Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 10:12 PM
Study NCT ID:
NCT01256450
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2010-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}, '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': 'The oral or written use of study results by the Investigator is not permitted without the express written consent from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study drug dispensing in open-label titration phase to about 1 week after last dose (Day 91/follow-up visit) in the double-blind phase, up to 17 weeks', 'description': 'Analysis for open-label titration phase based on Safety population; all enrolled subjects who receive at least 1 dose of study drug. Analysis for double-blind treatment phase is based on Randomized population; all subjects who were randomized into double-blind treatment, even if study drug was not taken.', 'eventGroups': [{'id': 'EG000', 'title': 'OL Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period', 'otherNumAtRisk': 330, 'otherNumAffected': 163, 'seriousNumAtRisk': 330, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period', 'otherNumAtRisk': 117, 'otherNumAffected': 36, 'seriousNumAtRisk': 117, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'DB Placebo Film', 'description': 'Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period', 'otherNumAtRisk': 118, 'otherNumAffected': 28, 'seriousNumAtRisk': 118, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 118, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 45, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Intensity From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '0.33', 'spread': '1.944', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '2.093', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.5870', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.646', 'ciUpperLimit': '0.366', '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 Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Intensity Over Time Using NRS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': 'Day 14', 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.469', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '1.624', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.20', 'spread': '1.539', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.877', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.535', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '1.840', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.709', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '1.926', 'groupId': 'OG001'}]}]}, {'title': 'Day 70', 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.783', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '2.056', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '0.29', 'spread': '1.984', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '2.058', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84', 'description': 'Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Treatment as Assessed by an NRS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '≥0% Response', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': '≥10% Response', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '≥20% Response', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '≥30% Response', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '≥40% Response', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '≥50% Response', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '≥60% Response', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '≥70% Response', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '≥80% Response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '≥90% Response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '≥100% Response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '9.4', 'groupId': 'OG000'}, {'value': '11.9', '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 due to adverse event 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.'}, {'type': 'SECONDARY', 'title': 'Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '-0.32', 'spread': '2.091', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '2.110', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).', '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': 'Effectiveness', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '25.172', 'groupId': 'OG000'}, {'value': '-9.03', 'spread': '27.804', 'groupId': 'OG001'}]}]}, {'title': 'Side effects', 'categories': [{'measurements': [{'value': '3.09', 'spread': '14.137', 'groupId': 'OG000'}, {'value': '10.88', 'spread': '18.243', 'groupId': 'OG001'}]}]}, {'title': 'Convenience', 'categories': [{'measurements': [{'value': '-3.12', 'spread': '13.294', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '14.081', 'groupId': 'OG001'}]}]}, {'title': 'Global satisfaction', 'categories': [{'measurements': [{'value': '-8.19', 'spread': '26.146', 'groupId': 'OG000'}, {'value': '-11.73', 'spread': '26.829', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).", '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Roland Morris Disability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '0.09', 'spread': '5.606', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '4.319', '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 ITT population; all randomized subjects who received at least 1 dose of double-blind study medication'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '-0.30', 'spread': '1.409', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.329', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).', '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.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '-0.27', 'spread': '1.312', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '1.369', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).', '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.'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': 'Day 7', 'categories': [{'measurements': [{'value': '0.87', 'spread': '1.143', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '1.103', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.135', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.289', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.239', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '1.325', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.250', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.358', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.89', 'spread': '1.245', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.364', 'groupId': 'OG001'}]}]}, {'title': 'Day 70', 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.197', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.611', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.277', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '1.276', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Day 91', 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.143', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.370', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase', 'description': 'Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.', 'unitOfMeasure': 'Tablets per day', '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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OL Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period'}, {'id': 'FG001', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '334'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of analgesic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment', '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': '117'}, {'comment': 'Subjects were randomized to DB treatment after completing OL titration in the previous period.', 'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of analgesic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Opioid withdrawal symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'Of 334 subjects who were enrolled in the open-label (OL) titration phase; a total of 235 completed the open-label titration phase and were randomized in the double-blind (DB) treatment phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Buprenorphine HCl Buccal Film', 'description': 'Buprenorphine HCl buccal film, 60, 120, 180, or 240 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': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '89'}, {'value': '51.5', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '77'}, {'value': '52.0', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis based on Randomized population; all subjects who were randomized into the double-blind period, even if study drug was not taken in the period'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2015-02-24', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2010-12-07', 'dispFirstSubmitQcDate': '2015-02-24', 'resultsFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2010-12-07', 'dispFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-04', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity From Baseline to Week 12', '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': 'Change From Baseline in Pain Intensity Over Time Using NRS Scale', 'timeFrame': 'Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84', 'description': 'Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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).'}, {'measure': 'Number of Participants With Response to Treatment as Assessed by an NRS Scale', 'timeFrame': 'Week 12', 'description': 'Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).'}, {'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 due to adverse event in the double-blind treatment phase.'}, {'measure': 'Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale', 'timeFrame': 'Baseline, Week 12', 'description': 'Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).'}, {'measure': 'Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM', 'timeFrame': 'Baseline, Week 12', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction)."}, {'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 Subject's Overall Satisfaction With Study Drug", 'timeFrame': 'Baseline, Week 12', 'description': 'Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).'}, {'measure': "Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug", 'timeFrame': 'Baseline, Week 12', 'description': 'Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).'}, {'measure': 'Use of Rescue Medication', 'timeFrame': 'Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase', 'description': 'Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['buccal soluble film', 'enriched enrollment', 'randomized withdrawal'], 'conditions': ['Pain', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).', 'detailedDescription': 'This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.\n\nBuprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant and non-nursing female aged 18 or older\n* History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \\[11 point numerical rating scale\\] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\], and muscle relaxants) of approximately 12 to 24 hours\n* Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer\n* Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures\n* Female subjects of childbearing potential must be using a recognized effective method of birth control\n* Written informed consent obtained at Screening, prior to any procedure being performed\n\nExclusion Criteria:\n\n* Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis\n* Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening\n* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia\n* Corrected QT (QTc) interval of \\>450 milliseconds on the 12-lead electrocardiogram (ECG)\n* History of long QT syndrome, or an immediate family member with this condition\n* Diagnosis of moderate to severe hepatic impairment.\n* History of severe emesis with opioids\n* Clinically significant sleep apnea'}, 'identificationModule': {'nctId': 'NCT01256450', 'briefTitle': 'Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioDelivery Sciences International'}, 'officialTitle': 'A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'BUP-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEMA Buprenorphine', 'description': 'buprenorphine buccal soluble film', 'interventionNames': ['Drug: Buprenorphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BEMA Placebo', 'description': 'placebo buccal soluble film', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['buprenorphine buccal soluble film', 'BEMA Buprenorphine', 'BELBUCA', 'buprenorphine HCl buccal film'], 'description': 'buccal soluble film; applied to the buccal mucosa twice daily', 'armGroupLabels': ['BEMA Buprenorphine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo buccal soluble film', 'Placebo buccal film', 'BEMA placebo'], 'description': 'buccal soluble film; applied to the buccal mucosa twice daily', 'armGroupLabels': ['BEMA Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Orthopaedic Center - Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center, UCSD Center for Pain Medicine', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Gold Coast Research, LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '32129', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Accord Clinical Research, LLC', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Taylor Research, LLC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Millennium Pain Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'MediSphere Medical Research Center, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66211', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'International Clinical Research Institute', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MedVadis Research Corporation', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Office of Stephen H. Miller, MD', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Across American', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Pain Management', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Urgent Care Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Andrew Finn, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioDelivery Sciences International, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioDelivery Sciences International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}