Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT02417935
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2015-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 91, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 86, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Open angle glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic gastroenteropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroduodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Xerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myringitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tinea manuum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and 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'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.358', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-2.286', 'spread': '0.133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.700', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.072', 'ciLowerLimit': '-0.295', 'ciUpperLimit': '0.439', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': '11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).\n\nMixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Improvement (PGI-I) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).\n\nMMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had at least one post baseline observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'title': 'Worst Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Relations with Other People', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.6', 'groupDescription': 'Worst Pain', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Least Pain', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'groupDescription': 'Average Pain', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Pain Right Now', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'groupDescription': 'General Activity', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'groupDescription': 'Mood', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.507', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.2', 'groupDescription': 'Walking Ability', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.1', 'groupDescription': 'Normal Work', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.1', 'groupDescription': 'Relations with other people', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'groupDescription': 'Sleep', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.1', 'groupDescription': 'Enjoyment of life', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.11', 'groupDescription': 'Average Interference Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.\n\nMMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BPI-SF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'title': 'Total Score', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Burning Pain', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Pressing Pain', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Paroxysmal Pain', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Evoked Pain', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Paresthesia/Dysesthesia', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '2.2', 'groupDescription': 'Total Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.355', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'groupDescription': 'Burning Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Pressing Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.4', 'groupDescription': 'Paroxysmal Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.345', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Evoked Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '.557', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Paresthesia/Dysesthesia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).\n\nAnalysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug \\& had baseline \\& at least one post-baseline observation for NPSI.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Improvement (CGI-I) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': "CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).\n\nMMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1004', 'spread': '0.0112', 'groupId': 'OG000'}, {'value': '0.1144', 'spread': '0.0112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0140', 'ciLowerLimit': '-0.0161', 'ciUpperLimit': '0.0441', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.\n\nANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline observation for EQ-5D.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.\n\nMMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BDI-II.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.166', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-2.160', 'spread': '0.131', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.976', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.005', 'ciLowerLimit': '-0.355', 'ciUpperLimit': '0.366', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.\n\nMMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for night pain NRS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.553', 'spread': '0.145', 'groupId': 'OG000'}, {'value': '-2.416', 'spread': '0.145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.503', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.136', 'ciLowerLimit': '-0.264', 'ciUpperLimit': '0.537', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.\n\nMMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for worst pain score NRS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.'}, {'id': 'OG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo.'}], 'classes': [{'title': '30% Reduction', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': '50% Reduction', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.632', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '30% reduction', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '.907', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '50% Reduction', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': '11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug \\& had baseline \\& at least one post-baseline observation for average pain score NRS .'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.\n\nParticipants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period.'}, {'id': 'FG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.\n\nParticipants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Tapering Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who discontinued treatment period had an option to enter the taper period', 'groupId': 'FG000', 'numSubjects': '134'}, {'comment': 'Participants who discontinued treatment period had an option to enter the taper period', 'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '12 week Treatment period, followed by 1 week Tapering period, followed by 1 week follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': 'Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period.\n\nParticipants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period.'}, {'id': 'BG001', 'title': 'Duloxetine', 'description': 'Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period.\n\nParticipants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '9.84', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '8.16', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '9.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Numeric Rating Scale (NRS)', 'classes': [{'title': 'Average Pain Score', 'categories': [{'measurements': [{'value': '5.35', 'spread': '1.129', 'groupId': 'BG000'}, {'value': '5.38', 'spread': '1.079', 'groupId': 'BG001'}, {'value': '5.37', 'spread': '1.102', 'groupId': 'BG002'}]}]}, {'title': 'Night Pain Score', 'categories': [{'measurements': [{'value': '4.61', 'spread': '1.855', 'groupId': 'BG000'}, {'value': '4.92', 'spread': '1.650', 'groupId': 'BG001'}, {'value': '4.76', 'spread': '1.759', 'groupId': 'BG002'}]}]}, {'title': 'Worst Pain Score', 'categories': [{'measurements': [{'value': '6.25', 'spread': '1.311', 'groupId': 'BG000'}, {'value': '6.22', 'spread': '1.237', 'groupId': 'BG001'}, {'value': '6.23', 'spread': '1.273', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '24-hour average pain, night pain \\& 24-hour worst pain severity scores were recorded on an 11-point NRS, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).Weekly mean was calculated based on daily score and used for the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Pain Inventory - Short Form (BPI-SF)', 'classes': [{'title': 'Worst Pain', 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.45', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '1.24', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '1.35', 'groupId': 'BG002'}]}]}, {'title': 'Least Pain', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.74', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '1.70', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '1.72', 'groupId': 'BG002'}]}]}, {'title': 'Average Pain', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '1.17', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '1.19', 'groupId': 'BG002'}]}]}, {'title': 'Pain Right Now', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.60', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '1.58', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '1.59', 'groupId': 'BG002'}]}]}, {'title': 'General Activity', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.14', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '2.21', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '2.18', 'groupId': 'BG002'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.32', 'groupId': 'BG000'}, {'value': '2.9', 'spread': '2.23', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '2.28', 'groupId': 'BG002'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.28', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '2.51', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '2.39', 'groupId': 'BG002'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.11', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '2.41', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '2.26', 'groupId': 'BG002'}]}]}, {'title': 'Relations With Other People', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.81', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '1.81', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '1.80', 'groupId': 'BG002'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.39', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '2.37', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '2.38', 'groupId': 'BG002'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.27', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '2.24', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '2.25', 'groupId': 'BG002'}]}]}, {'title': 'Average Interference Score', 'categories': [{'measurements': [{'value': '2.66', 'spread': '1.744', 'groupId': 'BG000'}, {'value': '2.63', 'spread': '1.875', 'groupId': 'BG001'}, {'value': '2.64', 'spread': '1.807', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BPI Severity (BPI-S) \\& BPI Interference Scores (BPI-I) are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory-II (BDI-II)', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '5.41', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '5.90', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '5.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neuropathic Pain Symptom Inventory (NPSI)', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '15.60', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '16.49', 'groupId': 'BG001'}, {'value': '31.9', 'spread': '16.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the patient. It assesses 5 different dimensions of neuropathic pain: burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. (range: 0 (no pain) -100 (worst imaginable pain)).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EuroQol 5 Dimension (EQ-5D)', 'classes': [{'categories': [{'measurements': [{'value': '0.7253', 'spread': '0.0903', 'groupId': 'BG000'}, {'value': '0.7337', 'spread': '0.1230', 'groupId': 'BG001'}, {'value': '0.7296', 'spread': '0.1079', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm.Range of the Index score is -0.111 - 1(higher score indicates better health state).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-02', 'size': 309841, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-25T06:34', 'hasProtocol': False}, {'date': '2014-05-29', 'size': 673119, 'label': 'Study Protocol: Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-25T06:36', 'hasProtocol': True}, {'date': '2014-09-30', 'size': 701414, 'label': 'Study Protocol: Protocol Amendment (a)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-25T06:37', 'hasProtocol': True}, {'date': '2015-04-17', 'size': 938924, 'label': 'Study Protocol: Protocol Amendment (b)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-25T06:39', 'hasProtocol': True}, {'date': '2016-08-05', 'size': 857896, 'label': 'Study Protocol: Protocol Amendment (c)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-25T06:41', 'hasProtocol': True}, {'date': '2016-09-14', 'size': 877607, 'label': 'Study Protocol: Protocol Amendment (d)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_005.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-25T06:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2015-04-13', 'resultsFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-09', 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 12', 'description': '11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).\n\nMixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean).'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Improvement (PGI-I) at 12 Weeks', 'timeFrame': 'Week 12', 'description': 'PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).\n\nMMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean.'}, {'measure': 'Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)', 'timeFrame': 'Baseline, Week 12', 'description': 'Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.\n\nMMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean.'}, {'measure': 'Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'Baseline, Week 12', 'description': 'NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).\n\nAnalysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean.'}, {'measure': 'Clinical Global Impression of Improvement (CGI-I) at 12 Weeks', 'timeFrame': 'Week 12', 'description': "CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).\n\nMMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean."}, {'measure': 'Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)', 'timeFrame': 'Baseline, Week 12', 'description': "The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.\n\nANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean."}, {'measure': 'Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score', 'timeFrame': 'Baseline, Week 12', 'description': 'Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.\n\nMMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean.'}, {'measure': 'Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS', 'timeFrame': 'Baseline, Week 12', 'description': 'Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.\n\nMMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean.'}, {'measure': 'Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.\n\nMMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean.'}, {'measure': 'Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks', 'timeFrame': 'Week 12', 'description': '11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '30271191', 'type': 'DERIVED', 'citation': 'Enomoto H, Yasuda H, Nishiyori A, Fujikoshi S, Furukawa M, Ishida M, Takahashi M, Tsuji T, Yoshikawa A, Alev L. Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin. J Pain Res. 2018 Sep 13;11:1857-1868. doi: 10.2147/JPR.S170646. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effectiveness and safety of the study drug known as duloxetine in participants with diabetic peripheral neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants present with pain due to bilateral, peripheral neuropathy\n* Participants who have hemoglobin A1c (HbA1c) ≤9.4% (National Glycohemoglobin Standardization Program \\[NGSP\\]) at screening\n* Participants who have HbA1c that has been measured 42 to 70 days prior to screening, and the range of variation in the values measured, thereafter, is within ±1.0% of the value measured at screening\n* Participants who have a score of at least 4 on the mean of the 24-hour average pain score measured using 11-point NRS (Numeric Rating Scale) in the daily diary (should be calculated from records 7 days immediately prior to randomization)\n* Participants who have made complete daily diary entries 80% or more of the time from screening to randomization\n\nExclusion Criteria:\n\n* Participants who have undergone renal transplant, or are currently undergoing renal dialysis\n* Participants who have uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension\n* Participants whose glycemic control has been poor within 70 days immediately prior to screening (for example, ketoacidosis requiring hospitalization, or hypoglycemia that may cause consciousness disorder)\n* Pregnant or lactating female participants, or male participants who are planning for their partners to be or become pregnant during the timeframe of the study\n* Participants who have hypersensitivity to multiple medications\n* Participants who answered "yes" to either question 4 (active suicidal ideation with some intent to act, without specific plan) or question 5 (active suicidal ideation with specific plan and intent) on the "suicidal ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or answered "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "suicidal behavior" portion of the C-SSRS; and the ideation or behavior occurred within the past month\n* Participants who have past history of psychiatric diseases, such as depression, anxiety disorder, eating disorder, etc., that required drug therapy in the past 1 year, or who are currently having complications of these diseases or any history of manic psychosis or bipolar disorder\n* Participants who have major depressive disorder as determined using the depression module of the Mini-International Neuropsychiatric Interview (MINI)\n* Participants who have complications of diseases that are considered to affect the assessment of diabetic peripheral neuropathic pain. For example, nerve diseases with pain other than diabetic peripheral neuropathic pain (cervical spondylosis, carpal tunnel syndrome, spinal canal stenosis, and post-herpetic pain), pain diseases other than nerve diseases (collagen diseases, gout, chronic obstructive arteriosclerosis, and arthritis), and other pain at the site of evaluation (skin diseases and traumatic injury) are excluded\n* Participants who have neuropathic pain suspected to be caused by alcohol\n* Participants who have been treated with a monoamine oxidase (MAO) inhibitor(s) within 14 days immediately prior to randomization. Participants who visited the investigator site 14 days prior to randomization, those who have been treated with MAO inhibitors(s), thereafter, are excluded\n* Participants who have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at a level ≥100 units/liter at screening\n* Participants who have total bilirubin at a level ≥1.5 milligrams/deciliter (mg/dL) at screening\n* Participants who have creatinine clearance (CrCL), calculated by Cockcroft-Gault, that is \\<1.0 milliliters/second (mL/s) (\\<60 mL/minute) at screening\n* Participants who have a white blood cell (WBC) value \\<2500/cubic millimeters (mm3), neutrophils \\<1500/mm3, or platelets \\<100×103/mm3 on their hematology tests at screening\n* Participants who are introduced to any treatments for diabetes, or a change in dosing regimen of any treatments for diabetes (exclude insulin treatment), or resumption of insulin treatment after screening\n* Participants who have been treated with prohibited concomitant drug(s), or who have undergone prohibited concomitant treatment(s) after screening\n* Participants who have taken restricted concomitant drugs 27 days immediately before screening, with continued use of the restricted concomitant drug prior to screening\n* Participants who have taken acetaminophen for 4 days or more 7 days immediately prior to randomization'}, 'identificationModule': {'nctId': 'NCT02417935', 'briefTitle': 'A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Japan Post-Marketing, Randomized, Double-Blind, Parallel-Group, Flexible Dose Comparative Study to Assess the Non-Inferiority of Duloxetine Compared With Pregabalin in Patients With Diabetic Peripheral Neuropathic Pain', 'orgStudyIdInfo': {'id': '14378'}, 'secondaryIdInfos': [{'id': 'F1J-JE-HMHA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'description': '20 milligrams (mg) duloxetine orally once a day (QD) for one week and then 40 mg duloxetine orally QD for 3 weeks. Duloxetine dosage may be increased up to 60 mg QD at week 4 or week 8. Placebo will be given with duloxetine for blinding. Dosage will be tapered down during the final week of the study.', 'interventionNames': ['Drug: Duloxetine', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': '150 mg pregabalin orally twice a day (BID) for 1 week and then 300 mg pregabalin orally BID for 3 weeks. Pregabalin dosage may be increased up to 450 mg BID at week 4 or 8, and increased up to 600 mg BID at week 8. Placebo will be given with pregabalin for blinding. Dosage will be tapered down during the final week of the study.', 'interventionNames': ['Drug: Pregabalin', 'Drug: Placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['LY248686'], 'description': 'Administered orally', 'armGroupLabels': ['Duloxetine']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Duloxetine', 'Pregabalin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shionogi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}