Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 5:12 AM
Study NCT ID:
NCT01057693
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.', 'otherNumAtRisk': 665, 'otherNumAffected': 331, 'seriousNumAtRisk': 665, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.', 'otherNumAtRisk': 147, 'otherNumAffected': 86, 'seriousNumAtRisk': 147, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.', 'otherNumAtRisk': 149, 'otherNumAffected': 94, 'seriousNumAtRisk': 149, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cystoid macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Retinopathy hypertensive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitreous disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lip disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophageal spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breakthrough pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 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'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Single-Blind Baseline', 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 19 (DB Phase)', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.09', 'groupDescription': 'P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 19 (DB Phase)', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Time to Loss of Pain Response (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) were not estimable because less than 50% participants experienced loss of pain response.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) were not estimable because less than 50% participants experienced loss of pain response.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'SB Baseline up to Week 19', 'description': 'Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (\\<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline (n= 663)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 6 (SB Phase) (n= 658)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6 (SB Phase)', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. "N" (number of participants analyzed): participants who were evaluable for this measure and "n": participants who were evaluable for specified time-point. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Pain Scores (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'Week 1 (n= 657)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (n= 636)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 (n= 613)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n= 585)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 (n= 565)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n= 548)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, 2, 3, 4, 5, 6', 'description': 'Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time-point.'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Pain Scores (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'DB Baseline (n= 147, 147)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n= 144, 145)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n= 143, 142)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n= 140, 133)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n= 138, 133)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 11 (n= 138, 128)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n= 135, 123)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n= 134, 122)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n= 133, 122)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n= 131, 118)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n= 132, 118)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 17 (n= 128, 115)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n= 128, 115)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 19 (n= 115, 104)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19', 'description': 'Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': '>=30 % Reduction', 'categories': [{'measurements': [{'value': '49.92', 'groupId': 'OG000'}]}]}, {'title': '>=50 % Reduction', 'categories': [{'measurements': [{'value': '27.22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': '>=30% Reduction', 'categories': [{'measurements': [{'value': '82.99', 'groupId': 'OG000'}, {'value': '79.19', 'groupId': 'OG001'}]}]}, {'title': '>=50% Reduction', 'categories': [{'measurements': [{'value': '62.59', 'groupId': 'OG000'}, {'value': '55.03', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline: Sleep disturbance (n= 665)', 'categories': [{'measurements': [{'value': '53.6', 'spread': '24.00', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Snoring (n= 664)', 'categories': [{'measurements': [{'value': '44.7', 'spread': '34.73', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Awaken SOB or With Headache (n=665)', 'categories': [{'measurements': [{'value': '18.9', 'spread': '24.18', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Quantity of sleep (n=663)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Sleep Adequacy (n=665)', 'categories': [{'measurements': [{'value': '39.2', 'spread': '23.22', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Somnolence (n=665)', 'categories': [{'measurements': [{'value': '42.6', 'spread': '23.49', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Sleep Problems Index (n=665)', 'categories': [{'measurements': [{'value': '49.2', 'spread': '18.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Sleep disturbance (n= 621)', 'categories': [{'measurements': [{'value': '33.6', 'spread': '24.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Snoring (n= 621)', 'categories': [{'measurements': [{'value': '39.9', 'spread': '34.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Awaken SOB or With Headache (n= 621)', 'categories': [{'measurements': [{'value': '12.6', 'spread': '22.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Quantity of sleep (n= 615)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Sleep Adequacy (n= 621)', 'categories': [{'measurements': [{'value': '52.6', 'spread': '25.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Somnolence (n= 621)', 'categories': [{'measurements': [{'value': '34.2', 'spread': '24.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Sleep Problems Index (n= 621)', 'categories': [{'measurements': [{'value': '34.4', 'spread': '18.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6', 'description': 'Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here "n" signifies participants who were evaluable for specified time-point.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Sleep disturbance', 'categories': [{'measurements': [{'value': '26.6', 'spread': '21.69', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '23.05', 'groupId': 'OG001'}]}]}, {'title': 'Snoring', 'categories': [{'measurements': [{'value': '41.9', 'spread': '36.24', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '35.95', 'groupId': 'OG001'}]}]}, {'title': 'Awaken SOB or With Headache', 'categories': [{'measurements': [{'value': '12.3', 'spread': '23.72', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '23.89', 'groupId': 'OG001'}]}]}, {'title': 'Quantity of sleep', 'categories': [{'measurements': [{'value': '6.7', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Adequacy', 'categories': [{'measurements': [{'value': '59.2', 'spread': '28.67', 'groupId': 'OG000'}, {'value': '59.0', 'spread': '27.67', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '29.7', 'spread': '24.39', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '22.98', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Problems Index', 'categories': [{'measurements': [{'value': '28.5', 'spread': '17.86', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '18.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'SB Baseline, Week 6', 'description': 'MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': 'MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Sleep Interference Score (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline (n= 663)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 (n= 657)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (n= 636)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 (n= 614)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n= 589)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 (n= 566)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n= 548)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 1, 2, 3, 4, 5, 6', 'description': 'Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point.'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Sleep Interference Score (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'DB Baseline (n= 147, 147)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n= 144, 145)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n= 143, 142)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n= 140, 134)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n= 138, 133)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 11 (n= 138, 128)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n= 136, 123)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n= 134, 122)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (n= 133, 122)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (n= 132, 120)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n= 132, 120)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 17 (n= 129, 116)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n= 128, 116)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 19 (n= 121, 111)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19', 'description': 'Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Endpoint Mean Sleep Interference Score (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '658', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Endpoint Mean Sleep Interference Score (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline: Total QOL Scores (n= 665)', 'categories': [{'measurements': [{'value': '42.6', 'spread': '22.22', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Ph Fn/Large Fiber (n= 665)', 'categories': [{'measurements': [{'value': '23.9', 'spread': '13.07', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Activities of Daily Living (n= 665)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.69', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Symptoms (n= 665)', 'categories': [{'measurements': [{'value': '10.8', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Small Fiber (n= 665)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.40', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Autonomic (n= 665)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Total QOL Scores (n= 618)', 'categories': [{'measurements': [{'value': '29.3', 'spread': '21.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Ph Fn/Large Fiber (n= 618)', 'categories': [{'measurements': [{'value': '15.8', 'spread': '12.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Activities of Daily Living (n= 618)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Symptoms (n= 618)', 'categories': [{'measurements': [{'value': '7.8', 'spread': '5.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Small Fiber (n= 618)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Autonomic (n= 618)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6', 'description': 'QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Total QOL Scores', 'categories': [{'measurements': [{'value': '21.9', 'spread': '20.02', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '21.06', 'groupId': 'OG001'}]}]}, {'title': 'Ph Fn/Large Fiber', 'categories': [{'measurements': [{'value': '11.4', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '12.72', 'groupId': 'OG001'}]}]}, {'title': 'Activities of Daily Living', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms', 'categories': [{'measurements': [{'value': '6.1', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '5.29', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber', 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Pain Visual Analog Scale (VAS) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline (n= 665)', 'categories': [{'measurements': [{'value': '68.1', 'spread': '13.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n= 621)', 'categories': [{'measurements': [{'value': '39.8', 'spread': '23.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6', 'description': 'Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point.'}, {'type': 'SECONDARY', 'title': 'Pain Visual Analog Scale (VAS) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '20.98', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '23.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline: Pain Severity (n= 665)', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: Pain Interference (n= 665)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Pain Severity (n= 637)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: Pain Interference (n= 637)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6', 'description': 'BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Pain Severity', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interference', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'SB Baseline: HADS-A (n= 663)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.95', 'groupId': 'OG000'}]}]}, {'title': 'SB Baseline: HADS-D (n= 663)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '3.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: HADS-A (n= 616)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 6: HADS-D (n= 616)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '3.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SB Baseline, Week 6', 'description': 'HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point.'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'HADS-A', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '3.56', 'groupId': 'OG001'}]}]}, {'title': 'HADS-D', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 19', 'description': 'HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}, {'title': 'Slightly Satisfied', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Neither Satisfied Nor Dissatisfied', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Slightly Dissatisfied', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Satisfied', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Neither Satisfied Nor Dissatisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Dissatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19', 'description': 'GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (\\>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.'}, {'id': 'FG001', 'title': 'Pregabalin DB', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants who experienced \\>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.'}], 'periods': [{'title': 'Single-Blind Phase (Up to Week 6)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '665'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '566'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Between Single-Blind and Double-Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '566'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind Phase (Week 7 to Week 19)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized, Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin SB', 'description': 'Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \\>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 Years', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': '45 to 64 Years', 'categories': [{'measurements': [{'value': '417', 'groupId': 'BG000'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '302', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '363', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 633}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-01-18', 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase', 'timeFrame': 'SB Baseline, Week 19 (DB Phase)', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.'}], 'secondaryOutcomes': [{'measure': 'Time to Loss of Pain Response (Double-Blind Phase)', 'timeFrame': 'SB Baseline up to Week 19', 'description': 'Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (\\<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.'}, {'measure': 'Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase', 'timeFrame': 'SB Baseline, Week 6 (SB Phase)', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.'}, {'measure': 'Weekly Mean Pain Scores (Single-Blind Phase)', 'timeFrame': 'Week 1, 2, 3, 4, 5, 6', 'description': 'Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.'}, {'measure': 'Weekly Mean Pain Scores (Double-Blind Phase)', 'timeFrame': 'DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19', 'description': 'Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.'}, {'measure': 'Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)', 'timeFrame': 'Week 6', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.'}, {'measure': 'Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.'}, {'measure': 'Patient Global Impression of Change (PGIC) (Single-Blind Phase)', 'timeFrame': 'Week 6', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported."}, {'measure': 'Patient Global Impression of Change (PGIC) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': "PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported."}, {'measure': 'Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.'}, {'measure': 'Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.'}, {'measure': 'Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.'}, {'measure': 'Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.'}, {'measure': 'Weekly Mean Sleep Interference Score (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 1, 2, 3, 4, 5, 6', 'description': 'Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.'}, {'measure': 'Weekly Mean Sleep Interference Score (Double-Blind Phase)', 'timeFrame': 'DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19', 'description': 'Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).'}, {'measure': 'Endpoint Mean Sleep Interference Score (Single-Blind Phase)', 'timeFrame': 'Week 6', 'description': 'Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).'}, {'measure': 'Endpoint Mean Sleep Interference Score (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).'}, {'measure': 'Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.'}, {'measure': 'Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.'}, {'measure': 'Pain Visual Analog Scale (VAS) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.'}, {'measure': 'Pain Visual Analog Scale (VAS) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.'}, {'measure': 'Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).'}, {'measure': 'Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)', 'timeFrame': 'SB Baseline, Week 6', 'description': 'HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.'}, {'measure': 'Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)', 'timeFrame': 'Week 6', 'description': 'GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.'}, {'measure': 'Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)', 'timeFrame': 'Week 19', 'description': 'GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic peripheral neuropathy', 'Lyrica', 'pregabalin', 'pain'], 'conditions': ['Diabetic Neuropathy, Painful']}, 'referencesModule': {'references': [{'pmid': '23887339', 'type': 'DERIVED', 'citation': 'Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081242&StudyName=Study%20Of%20Pregabalin%20%28Lyrica%29%20In%20Patients%20With%20Painful%20Diabetic%20Peripheral%20Neuropathy', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.\n\nExclusion Criteria:\n\n* Patients with other pain conditions cannot participate.'}, 'identificationModule': {'nctId': 'NCT01057693', 'briefTitle': 'Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY', 'orgStudyIdInfo': {'id': 'A0081242'}, 'secondaryIdInfos': [{'id': '2009-017389-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pregabalin (Lyrica)', 'interventionNames': ['Drug: pregabalin (Lyrica)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'pregabalin (Lyrica)', 'type': 'DRUG', 'description': 'Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.', 'armGroupLabels': ['pregabalin (Lyrica)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is supplied as capsules and given 3 times daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Greystone Medical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35476', 'city': 'Northport', 'state': 'Alabama', 'country': 'United States', 'facility': 'Neurology Clinic, PC', 'geoPoint': {'lat': 33.22901, 'lon': -87.57723}}, {'zip': '85295', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Horizon Clinical Research Associates, PLLC', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dedicated Clinical Research, Inc.', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dedicated Clinical Research', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novara Clinical Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Diagnostic Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Convergys Clinical Research, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Center for United Research, Inc.', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90015', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Healthcare Partners Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Keck School of Medicine, Department of Neurology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Richard S. 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