Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01675167
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2012-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'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': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalsite.inquiries@endo.com', 'title': 'Clinical Trial Coordinator', 'organization': 'Endo Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': "PI and Institution reserve the right to publish and present the results of the work performed provided that Institution and/or PI submits a copy of any proposed publication to Sponsor's agent for review and comment at least 90 days in advance of its presentation or submission for publication. In addition, if Sponsor's agent requests, Institution and/or PI will withhold publication or presentation for an additional 60 days to allow for establishing and preserving its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From informed consent at screening through 14 days after last dose in the double-blind treatment phase (up to 26 weeks)', 'description': 'Analysis based on Safety population; all enrolled subjects who received at least 1 dose of study drug in the respective period (open-label titration and double-blind treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'OL Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period', 'otherNumAtRisk': 810, 'otherNumAffected': 268, 'seriousNumAtRisk': 810, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period', 'otherNumAtRisk': 254, 'otherNumAffected': 42, 'seriousNumAtRisk': 254, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period', 'otherNumAtRisk': 256, 'otherNumAffected': 49, 'seriousNumAtRisk': 256, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 73, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 167, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 63, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 61, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 54, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pancreatitis relapsing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 810, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Average Daily Pain Intensity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '1.785', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '1.867', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.64', 'pValueComment': 'P value was adjusted using weighted z-test (CHW).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Treatment (Responder) Using NRS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'title': 'Responders with ≥30% pain reduction', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Responders with ≥50% pain reduction', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Responders with ≥30% pain reduction', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by stratum (dose level)', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Responders with ≥50% pain reduction', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by Stratum (Dose Level)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Prior to open-label titration to week 12 in double-blind treatment', 'description': 'Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Opioid Rescue Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'title': 'Week 1 (n=242, 246)', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=234, 204)', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=229, 189)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=229, 179)', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=222, 162)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=219, 161)', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=213, 154)', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=210, 152)', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=207, 146)', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=205, 145)', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Week 11 (n=203, 144)', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=201, 141)', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 12', 'description': 'Use of analgesic rescue medication recorded in subject diary', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.'}, {'type': 'SECONDARY', 'title': 'Time to Optimal Dose of Open-label Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'spread': '11.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 8 weeks in open-label titration', 'description': 'Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)', 'description': 'Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change \\[or condition has got worse\\]) to 7 (a great deal better, and a considerable improvement that made all the difference)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (19). Includes only participants with PGIC assessment at week 12 (n=231 buprenorphine and n=230 placebo).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Roland Morris Disability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '5.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with RMDQ assessment at week 12 (n=225 buprenorphine and n=231 placebo).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'title': 'Sleep problems index', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '7.857', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '8.359', 'groupId': 'OG001'}]}]}, {'title': 'Sleep disturbance', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '10.739', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '12.038', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '0.20', 'spread': '12.927', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '15.301', 'groupId': 'OG001'}]}]}, {'title': 'Sleep adequacy', 'categories': [{'measurements': [{'value': '0.13', 'spread': '17.924', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '18.326', 'groupId': 'OG001'}]}]}, {'title': 'Snoring', 'categories': [{'measurements': [{'value': '0.87', 'spread': '18.630', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '15.945', 'groupId': 'OG001'}]}]}, {'title': 'Awaken short of breath or headache', 'categories': [{'measurements': [{'value': '0.52', 'spread': '17.288', 'groupId': 'OG000'}, {'value': '-4.26', 'spread': '19.628', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'OG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'classes': [{'title': 'Quantity of Sleep/Optimal Sleep ≥7', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Quantity of Sleep/Optimal Sleep <7', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OL Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period'}, {'id': 'FG001', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'FG002', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}], 'periods': [{'title': 'Open-label Titration Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '815'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal due to opioid withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All subjects completing OL titration in the previous period were randomized to a DB treatment.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Subjects were randomized to DB treatment after completing OL titration in the previous period.', 'groupId': 'FG001', 'numSubjects': '254'}, {'comment': 'Subjects were randomized to DB treatment after completing OL titration in the previous period.', 'groupId': 'FG002', 'numSubjects': '257'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '206'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '110'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal due to opioid withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Of 1656 subjects screened, 938 subjects entered an analgesic taper phase and 1 subject was eligible to bypass the analgesic taper phase; a total of 815 subjects progressed to the open-label (OL) titration phase. Subjects who completed the open-label titration phase (511) were eligible for randomization in the double-blind (DB) treatment phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'BG001', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '78'}, {'value': '55.0', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '79'}, {'value': '54.0', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 815}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2015-03-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2012-08-27', 'dispFirstSubmitQcDate': '2015-06-10', 'resultsFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2012-08-27', 'dispFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Average Daily Pain Intensity Scores', 'timeFrame': 'Baseline, week 12', 'description': 'Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Response to Treatment (Responder) Using NRS Scale', 'timeFrame': 'Prior to open-label titration to week 12 in double-blind treatment', 'description': 'Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).'}, {'measure': 'Number of Subjects With Opioid Rescue Medication Use', 'timeFrame': 'Week 1 to Week 12', 'description': 'Use of analgesic rescue medication recorded in subject diary'}, {'measure': 'Time to Optimal Dose of Open-label Study Medication', 'timeFrame': 'Up to 8 weeks in open-label titration', 'description': 'Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment'}, {'measure': 'Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)', 'timeFrame': 'Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)', 'description': 'Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'Week 12', 'description': 'Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change \\[or condition has got worse\\]) to 7 (a great deal better, and a considerable improvement that made all the difference)'}, {'measure': 'Change From Baseline to Week 12 in Roland Morris Disability Questionnaire', 'timeFrame': 'Baseline, week 12', 'description': 'Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.'}, {'measure': 'Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale', 'timeFrame': 'Baseline, Week 12', 'description': 'Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).'}, {'measure': 'Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep', 'timeFrame': 'Week 12', 'description': 'Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CLBP', 'Chronic Low Back Pain', 'Chronic Pain', 'Back Pain'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of moderate to severe low back pain for ≥6 months\n* Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \\[PRN\\] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)\n* Stable health, as determine by Principal Investigator\n* Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year\n* Willing and able to comply with all protocol required visits and assessments\n\nExclusion Criteria:\n\n* Current cancer related pain or received chemotherapy within 6 months of screening\n* Subjects with history of other chronic painful conditions\n* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis\n* Allergy or contraindications of any opioid or acetaminophen\n* Surgical procedure for relief of pain within 6 months\n* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia\n* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)\n* History of long QT syndrome or a family member with this condition\n* Moderate to severe hepatic impairment\n* Moderate to severe renal impairment\n* Current or past history of alcohol abuse\n* Positive urine toxicology screen for drug of abuse\n* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values"}, 'identificationModule': {'nctId': 'NCT01675167', 'briefTitle': 'Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioDelivery Sciences International'}, 'officialTitle': 'Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia', 'orgStudyIdInfo': {'id': 'EN3409-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Buccal Film', 'description': 'Twice Daily Dosing', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Buprenorphine HCl Buccal Film', 'description': 'Twice Daily Dosing', 'interventionNames': ['Drug: Buprenorphine']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['BELBUCA', 'Buprenorphine HCl Buccal Film', 'BEMA Buprenorphine', 'EN3409'], 'description': 'Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily', 'armGroupLabels': ['Buprenorphine HCl Buccal Film']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Buccal Film', 'BEMA Placebo'], 'description': 'Matching Placebo Buccal Film twice daily', 'armGroupLabels': ['Placebo Buccal Film']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35565', 'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Haleyville Clinical Research LLC', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Horizon Research Group. 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