Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 5:58 AM
Study NCT ID:
NCT01117766
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2010-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.', 'otherNumAtRisk': 28, 'otherNumAffected': 20, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.', 'otherNumAtRisk': 30, 'otherNumAffected': 15, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tongue coated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradyphrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypnagogic hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Menopause and related conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=15,16)', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '1.735', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '1.730', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=18,21)', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '1.924', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.984', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.537', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.536', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)=participants with present pain intensity score \\>=4 out of 10 for brush evoked allodynia at screening and randomization, \\>=4 out of 7 non missing values in week prior to randomization, \\>4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=16,17)', 'categories': [{'measurements': [{'value': '-53.441', 'spread': '114.7084', 'groupId': 'OG000'}, {'value': '-49.180', 'spread': '94.3329', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=17,20)', 'categories': [{'measurements': [{'value': '-49.808', 'spread': '100.2094', 'groupId': 'OG000'}, {'value': '-18.921', 'spread': '104.3942', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6539', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.32', 'ciLowerLimit': '-70.20', 'ciUpperLimit': '45.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.872', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3678', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.91', 'ciLowerLimit': '-78.54', 'ciUpperLimit': '30.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.807', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Dynamic area brush in cm\\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \\* perpendicular height); Σ ( ½ ri \\* sin(45) r(i+1) ) = Σ ( (ri \\* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (Size 8, n=15,16)', 'categories': [{'measurements': [{'value': '-0.133', 'spread': '1.7494', 'groupId': 'OG000'}, {'value': '0.417', 'spread': '2.6063', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 16, n=15,16)', 'categories': [{'measurements': [{'value': '-1.356', 'spread': '2.4800', 'groupId': 'OG000'}, {'value': '0.208', 'spread': '2.6412', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 32, n=15,16)', 'categories': [{'measurements': [{'value': '-0.200', 'spread': '1.8551', 'groupId': 'OG000'}, {'value': '-0.188', 'spread': '2.1636', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 64, n=15,16)', 'categories': [{'measurements': [{'value': '-1.128', 'spread': '2.0304', 'groupId': 'OG000'}, {'value': '0.561', 'spread': '2.9543', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 128, n=15,16)', 'categories': [{'measurements': [{'value': '-1.267', 'spread': '1.6868', 'groupId': 'OG000'}, {'value': '-0.097', 'spread': '1.3385', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 256, n=15,16)', 'categories': [{'measurements': [{'value': '-0.773', 'spread': '2.2420', 'groupId': 'OG000'}, {'value': '-0.171', 'spread': '1.4133', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (Size 512, n=15,16)', 'categories': [{'measurements': [{'value': '-1.533', 'spread': '1.7873', 'groupId': 'OG000'}, {'value': '-0.480', 'spread': '1.1183', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 8, n=18,21)', 'categories': [{'measurements': [{'value': '-0.370', 'spread': '1.2674', 'groupId': 'OG000'}, {'value': '-0.429', 'spread': '1.7132', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 16, n=18,21)', 'categories': [{'measurements': [{'value': '-0.611', 'spread': '1.2693', 'groupId': 'OG000'}, {'value': '-0.889', 'spread': '2.2616', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 32, n=18,21)', 'categories': [{'measurements': [{'value': '-0.333', 'spread': '1.4597', 'groupId': 'OG000'}, {'value': '-0.825', 'spread': '2.1386', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 64, n=18,21)', 'categories': [{'measurements': [{'value': '-1.116', 'spread': '1.6152', 'groupId': 'OG000'}, {'value': '-0.462', 'spread': '3.1381', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 128, n=18,21)', 'categories': [{'measurements': [{'value': '-1.315', 'spread': '1.9322', 'groupId': 'OG000'}, {'value': '-0.841', 'spread': '2.2843', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 256, n=18,21)', 'categories': [{'measurements': [{'value': '-1.322', 'spread': '1.8729', 'groupId': 'OG000'}, {'value': '-0.751', 'spread': '2.5072', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (Size 512, n=18,21)', 'categories': [{'measurements': [{'value': '-1.836', 'spread': '1.7249', 'groupId': 'OG000'}, {'value': '-0.420', 'spread': '2.0238', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '-0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.342', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}, {'pValue': '0.1294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.370', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=16,17)', 'categories': [{'measurements': [{'value': '-75.571', 'spread': '148.8301', 'groupId': 'OG000'}, {'value': '-3.232', 'spread': '125.8041', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=17,20)', 'categories': [{'measurements': [{'value': '-75.834', 'spread': '133.9530', 'groupId': 'OG000'}, {'value': '-4.130', 'spread': '129.8261', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.54', 'ciLowerLimit': '-116.12', 'ciUpperLimit': '-6.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.298', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.06', 'ciLowerLimit': '-105.67', 'ciUpperLimit': '7.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.501', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Punctate allodynia area in cm\\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \\* perpendicular height); Σ ( ½ ri \\* sin(45) r(i+1) ) = Σ ( (ri \\* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (5 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-0.821', 'spread': '1.2039', 'groupId': 'OG000'}, {'value': '-1.402', 'spread': '3.0295', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (10 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-0.333', 'spread': '1.3318', 'groupId': 'OG000'}, {'value': '-1.313', 'spread': '2.0402', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (15 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-0.567', 'spread': '2.3442', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '1.3478', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (20 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-0.500', 'spread': '1.9365', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '1.4314', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (5 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.726', 'spread': '1.3375', 'groupId': 'OG000'}, {'value': '-0.703', 'spread': '2.4746', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (10 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.278', 'spread': '1.3086', 'groupId': 'OG000'}, {'value': '-0.810', 'spread': '1.6239', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (15 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.583', 'spread': '1.2632', 'groupId': 'OG000'}, {'value': '0.095', 'spread': '1.5622', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (20 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.111', 'spread': '1.4507', 'groupId': 'OG000'}, {'value': '-0.333', 'spread': '0.7130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '1.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.478', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}, {'pValue': '0.9673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.299', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (40 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-1.100', 'spread': '2.2216', 'groupId': 'OG000'}, {'value': '-0.625', 'spread': '2.3130', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (44 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '0.400', 'spread': '3.4959', 'groupId': 'OG000'}, {'value': '-0.938', 'spread': '2.8395', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (47 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-0.908', 'spread': '2.5249', 'groupId': 'OG000'}, {'value': '-0.578', 'spread': '3.3112', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visits 3 and 6) (50 degrees, n=15,16)', 'categories': [{'measurements': [{'value': '-1.385', 'spread': '2.8981', 'groupId': 'OG000'}, {'value': '-0.865', 'spread': '2.1050', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (40 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.639', 'spread': '2.5771', 'groupId': 'OG000'}, {'value': '-0.143', 'spread': '0.9506', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (44 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.444', 'spread': '4.1084', 'groupId': 'OG000'}, {'value': '-0.495', 'spread': '2.9959', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (47 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.337', 'spread': '3.0065', 'groupId': 'OG000'}, {'value': '-0.083', 'spread': '2.7679', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (50 degrees, n=18,21)', 'categories': [{'measurements': [{'value': '-0.566', 'spread': '2.2423', 'groupId': 'OG000'}, {'value': '-0.387', 'spread': '2.6689', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '1.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.642', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}, {'pValue': '0.8536', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.500', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical analysis was based on the average pain score across all levels of stimuli.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=19,18)', 'categories': [{'measurements': [{'value': '-1.456', 'spread': '1.8287', 'groupId': 'OG000'}, {'value': '-0.484', 'spread': '2.0721', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=18,18)', 'categories': [{'measurements': [{'value': '-1.397', 'spread': '1.4823', 'groupId': 'OG000'}, {'value': '-0.769', 'spread': '1.4778', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-2.73', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.586', 'estimateComment': "In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.", 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0403', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.467', 'estimateComment': "In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.", 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (\\>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=15,16)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=18,21)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.433', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.54', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '-0.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.465', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': "PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'title': 'Week 3 (Visits 3 and 6) (n=7,10)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visits 4 and 7) (n=11,11)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.722', 'groupDescription': 'Week 3 (Visits 3 and 6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.588', 'groupDescription': 'Week 4 (Visits 4 and 7)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to match the pregabalin doses BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.67', 'spread': '21.404', 'groupId': 'OG000'}, {'value': '-7.72', 'spread': '19.384', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-17.13', 'ciUpperLimit': '8.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.292', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 (Visits 4 and 7) of each period', 'description': 'NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. n=18, 18; number of participants contributing to the mean.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin Then Placebo', 'description': 'During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.'}, {'id': 'FG001', 'title': 'Placebo Then Pregabalin', 'description': 'Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Includes all participants randomized to receive pregabalin first and placebo first.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2010-05-04', 'resultsFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-09-01', 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.'}, {'measure': 'Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Dynamic area brush in cm\\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \\* perpendicular height); Σ ( ½ ri \\* sin(45) r(i+1) ) = Σ ( (ri \\* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)'}, {'measure': 'Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.'}, {'measure': 'Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Punctate allodynia area in cm\\^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length \\* perpendicular height); Σ ( ½ ri \\* sin(45) r(i+1) ) = Σ ( (ri \\* r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)'}, {'measure': 'Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.'}, {'measure': 'Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (\\>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).'}, {'measure': "Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7", 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': "PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse."}, {'measure': 'Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7', 'timeFrame': 'Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period', 'description': 'Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"'}, {'measure': 'Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7', 'timeFrame': 'Week 4 (Visits 4 and 7) of each period', 'description': 'NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.'}]}, 'conditionsModule': {'keywords': ['Methodology', 'Quantitative Sensory Testing', 'Neuropathies Pain', 'Pregabalin'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011015&StudyName=Study%20To%20Assess%20The%20Reproducibility%20And%20Sensitivity%20Of%20Quantitative%20Sensory%20Testing%20In%20Patients%20With%20Neuropathic%20Pain%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.', 'detailedDescription': 'Methodology to assess reproducibility and sensitivity of quantitative sensory testing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.\n* A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.\n* Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.\n\nExclusion Criteria:\n\n* Patients who have undergone neurolytic or neurosurgical therapy.\n* Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.\n* Patients who have previously been treated with pregabalin.'}, 'identificationModule': {'nctId': 'NCT01117766', 'briefTitle': 'Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo', 'orgStudyIdInfo': {'id': 'A9011015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active drug', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients', 'armGroupLabels': ['Active drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'BID dosing for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}