Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-31 @ 2:53 PM
Study NCT ID:
NCT00424593
Status:
COMPLETED
Last Update Posted:
2009-11-20
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Duloxetine Versus Placebo in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'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': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data in this module is for the 13 Week acute double-blind treatment phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase', 'otherNumAtRisk': 115, 'otherNumAffected': 72, 'seriousNumAtRisk': 115, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks', 'otherNumAtRisk': 121, 'otherNumAffected': 59, 'seriousNumAtRisk': 121, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.32', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.', 'statisticalMethod': 'Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 13', 'description': 'A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with baseline and at least one non-missing post-baseline value.'}, {'type': 'SECONDARY', 'title': "Patient's Global Impression of Improvement (PGI-I)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 13', 'description': "A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with at least one non-missing post-baseline value. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': '13 Week Baseline', 'categories': [{'measurements': [{'value': '10.39', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '10.87', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': '13 Week Change from Baseline', 'categories': [{'measurements': [{'value': '-3.13', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '4.85', 'groupId': 'OG001'}]}]}, {'title': '54 Week Baseline (n=59, n=82)', 'categories': [{'measurements': [{'value': '7.83', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '9.59', 'spread': '6.11', 'groupId': 'OG001'}]}]}, {'title': '54 Week Change from Baseline (n=59, n=82)', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '5.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for 13 Week Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Average Pain Score Baseline', 'categories': [{'measurements': [{'value': '5.94', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain Score Change from Baseline', 'categories': [{'measurements': [{'value': '-1.92', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain Score Baseline', 'categories': [{'measurements': [{'value': '6.91', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain Score Change from Baseline', 'categories': [{'measurements': [{'value': '-1.97', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Night Pain Score Baseline', 'categories': [{'measurements': [{'value': '5.46', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'Night Pain Score Change from Baseline', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '1.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Average Pain Score Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Worst Pain Score Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Night Pain Score Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'description': '24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Worst Pain Score Week 13 Baseline', 'categories': [{'measurements': [{'value': '7.43', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.55', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-1.72', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain Score Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '4.49', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain Score Week 13 Baseline', 'categories': [{'measurements': [{'value': '4.22', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain Score Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.36', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'Least Pain Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain Score Week 13 Baseline', 'categories': [{'measurements': [{'value': '5.91', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.08', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain Score Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '3.40', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now Score Week 13 Baseline', 'categories': [{'measurements': [{'value': '5.42', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '5.55', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.29', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now Score Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.75', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Pain Right Now Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'General Activity Week 13 Baseline', 'categories': [{'measurements': [{'value': '5.07', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '5.60', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'General Activity Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'General Activity Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '3.11', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'General Activity Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Mood Week 13 Baseline', 'categories': [{'measurements': [{'value': '3.89', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Mood Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.70', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '3.24', 'groupId': 'OG001'}]}]}, {'title': 'Mood Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '1.89', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': 'Mood Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability Week 13 Baseline', 'categories': [{'measurements': [{'value': '4.49', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.01', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.49', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Walking Ability Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work Week 13 Baseline', 'categories': [{'measurements': [{'value': '5.01', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '5.39', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.10', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Normal Work Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Relations With People Week 13 Baseline', 'categories': [{'measurements': [{'value': '2.75', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Relations With People Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': 'Relations With People Week 54 Baseline (n=80,n=97)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Relations With People Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Week 13 Baseline', 'categories': [{'measurements': [{'value': '4.12', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.66', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.38', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life Week 13 Baseline', 'categories': [{'measurements': [{'value': '3.57', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '1.61', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Enjoyment of Life Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference Week 13 Baseline', 'categories': [{'measurements': [{'value': '4.13', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.76', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Average Interference Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Worst Pain Score Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Least Pain Score Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Average Pain Score Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Pain Right Now Score Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for General Activity Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Mood Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Walking Ability Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Normal Work Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Relations With People Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Sleep Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Enjoyment of Life Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Average Interference Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Week 13 Baseline', 'categories': [{'measurements': [{'value': '3.23', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Baseline (n=81, n=97)', 'categories': [{'measurements': [{'value': '2.21', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Change from Baseline (n=81, n=97)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 13', 'description': 'Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with non-missing response values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 13', 'description': 'Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants with non-missing response values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Week 13 Baseline', 'categories': [{'measurements': [{'value': '8.03', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '8.29', 'spread': '5.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.01', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Baseline (n=71, n=86)', 'categories': [{'measurements': [{'value': '5.42', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '6.70', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Change from Baseline (n=71, n=86)', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Mental Component Summary Baseline', 'categories': [{'measurements': [{'value': '49.69', 'spread': '9.99', 'groupId': 'OG000'}, {'value': '49.60', 'spread': '11.11', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Summary Change from Baseline', 'categories': [{'measurements': [{'value': '2.05', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '10.45', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Summary Baseline', 'categories': [{'measurements': [{'value': '33.39', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '32.62', 'spread': '7.37', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Summary Change from Baseline', 'categories': [{'measurements': [{'value': '5.69', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '8.97', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain Baseline', 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.42', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain Change from Baseline', 'categories': [{'measurements': [{'value': '1.55', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'General Health Baseline', 'categories': [{'measurements': [{'value': '16.27', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '15.75', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'General Health Change from Baseline', 'categories': [{'measurements': [{'value': '1.73', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '4.08', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health Baseline', 'categories': [{'measurements': [{'value': '22.06', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '21.95', 'spread': '4.52', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health Change from Baseline', 'categories': [{'measurements': [{'value': '1.19', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Baseline', 'categories': [{'measurements': [{'value': '19.53', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '19.87', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Change from Baseline', 'categories': [{'measurements': [{'value': '2.59', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional Baseline', 'categories': [{'measurements': [{'value': '4.57', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional Change from Baseline', 'categories': [{'measurements': [{'value': '0.44', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical Baseline', 'categories': [{'measurements': [{'value': '5.24', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical Change from Baseline', 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning Baseline', 'categories': [{'measurements': [{'value': '7.83', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning Change from Baseline', 'categories': [{'measurements': [{'value': '0.51', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Vitality Baseline', 'categories': [{'measurements': [{'value': '15.16', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '14.79', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': 'Vitality Change from Baseline', 'categories': [{'measurements': [{'value': '1.08', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '4.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Mental Component Summary Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Physical Component Summary Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Bodily Pain Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for General Health Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Mental Health Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Physical Functioning Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.170', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Role-Emotional Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.306', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Role-Physical Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Social Functioning Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Vitality Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'description': "The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \\[MCS\\] and physical component summary \\[PCS\\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Absenteeism Score Week 13 Baseline (n=35, n=32)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Absenteeism Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Absenteeism Score Week 54 Baseline (n=24, n=32)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Absenteeism Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism Score Week 13 Baseline (n=37, n=31)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism Score Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism Score Week 54 Baseline (n=24, n=34)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Presenteeism Score Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Work Productivity Loss Week 13 Baseline(n=33,n=29)', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Work Productivity Loss Week 13 Change', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Work Productivity Loss Week 54 Baseline(n=24,n=32)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Work Productivity Loss Week 54 Change', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Activity Impairment Week 13 Baseline (n=103,n=105)', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Activity Impairment Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Activity Impairment Week 54 Baseline (n=70, n=86)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Activity Impairment Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.063', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Absenteeism Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.452', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Presenteeism Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.736', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Work Productivity Loss Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Work Activity Impairment Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.\n\n1. Absenteeism=(Q2/(Q2+Q4))\\*100\n2. Presenteeism=(Q5/10)\\*100\n3. Work productivity loss=(Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\])\\*100\n4. Activity Impairment=(Q6/10)\\*100', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Week 13 Baseline', 'categories': [{'measurements': [{'value': '6.94', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '6.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '6.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '5.93', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '7.69', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Change from Baseline (n=80, n=97)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '6.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 13 Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Anxiety Subscale Baseline (n=102, n=104)', 'categories': [{'measurements': [{'value': '4.94', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '4.41', 'spread': '3.67', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety Subscale Change from Baseline', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'Depression Subscale Baseline (n=103, n=105)', 'categories': [{'measurements': [{'value': '3.65', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '3.42', 'groupId': 'OG001'}]}]}, {'title': 'Depression Subscale Change from Baseline', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.122', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Anxiety Subscale Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.262', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Depression Subscale Change from Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'description': "A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.90', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '25.10', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '0.57', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '2.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on rank transformation.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'unitOfMeasure': 'millimole per Liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '303.23', 'spread': '79.04', 'groupId': 'OG000'}, {'value': '298.07', 'spread': '82.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-6.27', 'spread': '37.81', 'groupId': 'OG000'}, {'value': '8.68', 'spread': '43.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA based on rank transformation.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13', 'unitOfMeasure': 'micromole per Liter (μmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Week 13 Baseline', 'categories': [{'measurements': [{'value': '72.21', 'spread': '8.90', 'groupId': 'OG000'}, {'value': '72.31', 'spread': '9.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '2.05', 'spread': '10.60', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '10.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Baseline (n=76, n=90)', 'categories': [{'measurements': [{'value': '74.95', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '71.03', 'spread': '7.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.46', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '7.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 13 Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Systolic Blood Pressure (SBP) Week 13 Baseline', 'categories': [{'measurements': [{'value': '127.44', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '127.62', 'spread': '14.75', 'groupId': 'OG001'}]}]}, {'title': 'SBP Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '11.12', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '13.30', 'groupId': 'OG001'}]}]}, {'title': 'SBP Week 54 Baseline (n=76, n=90)', 'categories': [{'measurements': [{'value': '127.04', 'spread': '14.10', 'groupId': 'OG000'}, {'value': '127.07', 'spread': '14.99', 'groupId': 'OG001'}]}]}, {'title': 'SBP Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-1.42', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '12.98', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure (DBP) Week 13 Baseline', 'categories': [{'measurements': [{'value': '79.92', 'spread': '8.63', 'groupId': 'OG000'}, {'value': '80.38', 'spread': '8.36', 'groupId': 'OG001'}]}]}, {'title': 'DBP Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '0.32', 'spread': '8.27', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'DBP Week 54 Baseline (n=76, n=90)', 'categories': [{'measurements': [{'value': '81.53', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '79.74', 'spread': '8.74', 'groupId': 'OG001'}]}]}, {'title': 'DBP Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '-2.00', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for SBP Week 13 Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for DBP Week 13 Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'classes': [{'title': 'Week 13 Baseline', 'categories': [{'measurements': [{'value': '76.63', 'spread': '14.83', 'groupId': 'OG000'}, {'value': '76.29', 'spread': '14.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 Change from Baseline', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Baseline (n=81, n=97)', 'categories': [{'measurements': [{'value': '76.57', 'spread': '14.61', 'groupId': 'OG000'}, {'value': '75.34', 'spread': '13.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 54 Change from Baseline', 'categories': [{'measurements': [{'value': '1.42', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 13 Change from Baseline.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 13, Week 54', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.\n\nNote: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serious Adverse Events During the Dose-Blind Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}], 'classes': [{'title': 'Patients with ≥1 Serious Adverse Event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Accidental overdose', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute tonsillitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Angiopathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Back pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Femur fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hand fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Road traffic accident', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal ideation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Tonsillitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 13 though Week 54', 'description': 'Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}], 'classes': [{'title': 'Headache', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal pain upper', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Hyperhidrosis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 13 through Week 54', 'description': 'Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}], 'periods': [{'title': 'Acute Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Dose-Blind Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '83 duloxetine patients from the acute phase entered the dose-blind period.', 'groupId': 'FG000', 'numSubjects': '181'}, {'comment': '98 placebo patients from acute phase entered dose-blind period and received duloxetine.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.81', 'spread': '14.92', 'groupId': 'BG000'}, {'value': '51.15', 'spread': '13.46', 'groupId': 'BG001'}, {'value': '51.47', 'spread': '14.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.63', 'spread': '4.42', 'groupId': 'BG000'}, {'value': '27.03', 'spread': '3.81', 'groupId': 'BG001'}, {'value': '27.33', 'spread': '4.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Pain Inventory (BPI) Average Pain Score', 'classes': [{'categories': [{'measurements': [{'value': '5.91', 'spread': '1.59', 'groupId': 'BG000'}, {'value': '5.96', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '5.94', 'spread': '1.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Chronic Lower Back Pain Since Onset', 'classes': [{'categories': [{'measurements': [{'value': '8.79', 'spread': '8.75', 'groupId': 'BG000'}, {'value': '9.54', 'spread': '8.60', 'groupId': 'BG001'}, {'value': '9.18', 'spread': '8.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '165.92', 'spread': '10.39', 'groupId': 'BG000'}, {'value': '167.40', 'spread': '11.34', 'groupId': 'BG001'}, {'value': '166.68', 'spread': '10.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.24', 'spread': '14.71', 'groupId': 'BG000'}, {'value': '75.89', 'spread': '13.94', 'groupId': 'BG001'}, {'value': '76.06', 'spread': '14.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2007-01-17', 'resultsFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-16', 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious Adverse Events During the Dose-Blind Extension Phase', 'timeFrame': 'Week 13 though Week 54', 'description': 'Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.'}, {'measure': 'Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase', 'timeFrame': 'Week 13 through Week 54', 'description': 'Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores', 'timeFrame': 'Baseline, Week 13', 'description': 'A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).'}], 'secondaryOutcomes': [{'measure': "Patient's Global Impression of Improvement (PGI-I)", 'timeFrame': 'Week 13', 'description': "A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse)."}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).'}, {'measure': 'Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale', 'timeFrame': 'Baseline, Week 13', 'description': '24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) 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.'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).'}, {'measure': 'Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria', 'timeFrame': 'Week 13', 'description': 'Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.'}, {'measure': 'Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria', 'timeFrame': 'Week 13', 'description': 'Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.'}, {'measure': 'Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)', 'timeFrame': 'Baseline, Week 13', 'description': "The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \\[MCS\\] and physical component summary \\[PCS\\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30."}, {'measure': 'Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)', 'timeFrame': 'Baseline, Week 13', 'description': 'The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.\n\n1. Absenteeism=(Q2/(Q2+Q4))\\*100\n2. Presenteeism=(Q5/10)\\*100\n3. Work productivity loss=(Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\])\\*100\n4. Activity Impairment=(Q6/10)\\*100'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores', 'timeFrame': 'Baseline, Week 13, Week 54', 'description': 'A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.'}, {'measure': 'Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores', 'timeFrame': 'Baseline, Week 13', 'description': "A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'"}, {'measure': 'Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate', 'timeFrame': 'Baseline, Week 13'}, {'measure': 'Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid', 'timeFrame': 'Baseline, Week 13'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate', 'timeFrame': 'Baseline, Week 13, Week 54'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure', 'timeFrame': 'Baseline, Week 13, Week 54'}, {'measure': 'Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight', 'timeFrame': 'Baseline, Week 13, Week 54'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Back Pain Without Radiation']}, 'referencesModule': {'references': [{'pmid': '24650448', 'type': 'DERIVED', 'citation': 'Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.'}, {'pmid': '20546509', 'type': 'DERIVED', 'citation': 'Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.'}, {'pmid': '20461028', 'type': 'DERIVED', 'citation': 'Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.\n\nWhether duloxetine once daily can help patients with Chronic Low Back Pain.\n\nPatients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female outpatients 18 years of age with chronic low back pain\n* Females of child bearing potential must test negative on a pregnancy test at visit 1.\n\nExclusion Criteria:\n\n* Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness\n* Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions\n* Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study\n* Have acute liver injury (such as hepatitis) or severe cirrhosis\n* Have had previous exposure to duloxetine\n* Have a body mass index (BMI) over 40\n* Have a major depressive disorder\n* Require daily narcotics\n* Have suicidal risk\n* Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures'}, 'identificationModule': {'nctId': 'NCT00424593', 'briefTitle': 'Duloxetine Versus Placebo in Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '10544'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMEN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'every day (QD), by mouth (PO), 13 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['LY248686', 'Cymbalta'], 'description': '30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase', 'armGroupLabels': ['Duloxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'every day (QD), by mouth (PO), 13 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80060240', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '04026-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04027-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '12400', 'city': 'Saint-Affrique', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 43.95575, 'lon': 2.88915}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '73479', 'city': 'Ellwangen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 48.96164, 'lon': 10.13173}}, {'zip': '82166', 'city': 'Gräfelfing', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 48.11878, 'lon': 11.42939}}, {'zip': '22143', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '65191', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '66260', 'city': 'San Pedro Garza García', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 25.6604, 'lon': -100.40651}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3039 BD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}