Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-04 @ 7:51 PM
Study NCT ID:
NCT00941304
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2009-07-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'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': 'D010098', 'term': 'Oxycodone'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study drug administration (day 1) to follow-up visit (day 6 to 10)', 'description': 'Analysis based on Safety population; all subjects who received any study drug', 'eventGroups': [{'id': 'EG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule', 'otherNumAtRisk': 31, 'otherNumAffected': 9, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule', 'otherNumAtRisk': 30, 'otherNumAffected': 18, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule', 'otherNumAtRisk': 31, 'otherNumAffected': 25, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films', 'otherNumAtRisk': 31, 'otherNumAffected': 6, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alveolar osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity Difference From Baseline to 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '6.016', 'spread': '19.9786', 'groupId': 'OG000'}, {'value': '11.867', 'spread': '20.7418', 'groupId': 'OG001'}, {'value': '11.282', 'spread': '22.9711', 'groupId': 'OG002'}, {'value': '5.283', 'spread': '17.6360', 'groupId': 'OG003'}, {'value': '4.290', 'spread': '14.8645', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '.4739', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.34', 'ciLowerLimit': '-5.94', 'ciUpperLimit': '12.62', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.2183', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.26', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '16.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.0809', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.74', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '18.56', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 hours', 'description': 'Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief Over 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '7.274', 'spread': '8.7136', 'groupId': 'OG000'}, {'value': '9.858', 'spread': '9.3550', 'groupId': 'OG001'}, {'value': '10.500', 'spread': '9.9358', 'groupId': 'OG002'}, {'value': '6.392', 'spread': '8.6235', 'groupId': 'OG003'}, {'value': '6.242', 'spread': '6.6813', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Relief and Intensity Differences Over 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '13.290', 'spread': '28.1677', 'groupId': 'OG000'}, {'value': '21.725', 'spread': '29.7031', 'groupId': 'OG001'}, {'value': '21.782', 'spread': '32.2047', 'groupId': 'OG002'}, {'value': '11.675', 'spread': '25.8038', 'groupId': 'OG003'}, {'value': '10.532', 'spread': '20.5848', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Relief and Intensity Differences Over 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '0.339', 'spread': '3.4896', 'groupId': 'OG000'}, {'value': '1.533', 'spread': '3.5718', 'groupId': 'OG001'}, {'value': '1.056', 'spread': '3.9769', 'groupId': 'OG002'}, {'value': '0.850', 'spread': '3.5505', 'groupId': 'OG003'}, {'value': '1.484', 'spread': '3.6009', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Peak Pain Intensity Difference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '3.35', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '2.50', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '2.61', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Peak Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '1.36', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '1.33', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Onset of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to onset of analgesia and/or corresponding 95% confidence interval (CI) could not be determined as more than 50% of the subjects in treatment group failed to activate the stopwatch times within the protocol-specified 8-hour window.', 'groupId': 'OG000', 'lowerLimit': '3.083', 'upperLimit': 'NA'}, {'value': '2.43', 'comment': 'Median time to onset of analgesia and/or corresponding 95% confidence interval (CI) could not be determined as more than 50% of the subjects in treatment group failed to activate the stopwatch times within the protocol-specified 8-hour window.', 'groupId': 'OG001', 'lowerLimit': '0.617', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to onset of analgesia and/or corresponding 95% confidence interval (CI) could not be determined as more than 50% of the subjects in treatment group failed to activate the stopwatch times within the protocol-specified 8-hour window.', 'groupId': 'OG002', 'lowerLimit': '0.750', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to onset of analgesia and/or corresponding 95% confidence interval (CI) could not be determined as more than 50% of the subjects in treatment group failed to activate the stopwatch times within the protocol-specified 8-hour window.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to onset of analgesia and/or corresponding 95% confidence interval (CI) could not be determined as more than 50% of the subjects in treatment group failed to activate the stopwatch times within the protocol-specified 8-hour window.', 'groupId': 'OG004', 'lowerLimit': '1.017', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 hours', 'description': 'Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Duration of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '1.667', 'upperLimit': '5.083'}, {'value': '2.62', 'groupId': 'OG001', 'lowerLimit': '1.783', 'upperLimit': '19.117'}, {'value': '4.12', 'comment': 'Corresponding 95% CI for duration of analgesia could not be determined as many subjects did not use rescue medication within 24 hours.', 'groupId': 'OG002', 'lowerLimit': '2.067', 'upperLimit': 'NA'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.583', 'upperLimit': '3.300'}, {'value': '2.17', 'groupId': 'OG004', 'lowerLimit': '1.683', 'upperLimit': '2.750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'title': 'Excellent at 8 hours', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}, {'value': '6.7', 'groupId': 'OG003'}, {'value': '3.2', 'groupId': 'OG004'}]}]}, {'title': 'Excellent at 24 hours', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours and 24 hours', 'description': 'Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication you received for pain?"', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication for this subject?"', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Assessment Using CNS-VS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'OG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'OG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'classes': [{'title': 'Cognitive flexibility', 'categories': [{'measurements': [{'value': '5.9', 'spread': '17.14', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '18.93', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '14.53', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '10.81', 'groupId': 'OG003'}, {'value': '2.1', 'spread': '17.56', 'groupId': 'OG004'}]}]}, {'title': 'Executive functioning', 'categories': [{'measurements': [{'value': '5.7', 'spread': '17.35', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '16.00', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '13.49', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '10.83', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '17.19', 'groupId': 'OG004'}]}]}, {'title': 'Processing speed', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.73', 'groupId': 'OG001'}, {'value': '-9.1', 'spread': '14.48', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '9.12', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '9.63', 'groupId': 'OG004'}]}]}, {'title': 'Reaction time', 'categories': [{'measurements': [{'value': '26.9', 'spread': '79.82', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '102.16', 'groupId': 'OG001'}, {'value': '29.7', 'spread': '157.55', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '56.09', 'groupId': 'OG003'}, {'value': '-8.9', 'spread': '61.13', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening), 2 hours 15 minutes postdose', 'description': 'Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(\\*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that "lower score is better", otherwise higher scores are better.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'FG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'FG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'FG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '153', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '0.25-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'BG001', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M2', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule'}, {'id': 'BG002', 'title': '0.5-mg Buprenorphine HCl Buccal Film, M1', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo oral capsule and 2 placebo buccal films'}, {'id': 'BG004', 'title': 'Oxycodone 5 mg', 'description': 'Oxycodone 5-mg oral capsule and 2 placebo buccal films'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '30'}, {'value': '21.0', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '30'}, {'value': '21.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '27'}, {'value': '22.0', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '28'}, {'value': '21.0', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '29'}, {'value': '21.0', 'groupId': 'BG005', 'lowerLimit': '18', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '96', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis is based on Safety population; all subjects who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2015-02-24', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2009-07-15', 'dispFirstSubmitQcDate': '2015-02-24', 'resultsFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2009-07-16', 'dispFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference From Baseline to 8 Hours', 'timeFrame': 'Baseline, 8 hours', 'description': 'Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"'}], 'secondaryOutcomes': [{'measure': 'Total Pain Relief Over 8 Hours', 'timeFrame': '8 hours', 'description': 'Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"'}, {'measure': 'Sum of Pain Relief and Intensity Differences Over 8 Hours', 'timeFrame': '8 hours', 'description': 'Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"'}, {'measure': 'Sum of Pain Relief and Intensity Differences Over 2 Hours', 'timeFrame': '2 hours', 'description': 'Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"'}, {'measure': 'Peak Pain Intensity Difference', 'timeFrame': '24 hours', 'description': 'The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"'}, {'measure': 'Peak Pain Relief', 'timeFrame': '24 hours', 'description': 'Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"'}, {'measure': 'Onset of Analgesia', 'timeFrame': '8 hours', 'description': 'Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.'}, {'measure': 'Duration of Analgesia', 'timeFrame': '24 hours', 'description': 'Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.'}, {'measure': 'Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"', 'timeFrame': '8 hours and 24 hours', 'description': 'Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication you received for pain?"'}, {'measure': 'Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug', 'timeFrame': '24 hours', 'description': 'Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication for this subject?"'}, {'measure': 'Change From Baseline in Cognitive Assessment Using CNS-VS', 'timeFrame': 'Baseline (screening), 2 hours 15 minutes postdose', 'description': 'Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(\\*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that "lower score is better", otherwise higher scores are better.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone\n* males or non-pregnant females, aged 18 to 45 years\n* good general health and capable of providing informed consent\n\nExclusion Criteria:\n\n* history of substance abuse or dependence\n* positive urine toxicology screen or alcohol breath test\n* history of hypersensitivity to or allergy to any study drug\n* donation of blood within prior 30 days\n* use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours'}, 'identificationModule': {'nctId': 'NCT00941304', 'briefTitle': 'Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioDelivery Sciences International'}, 'officialTitle': 'A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction', 'orgStudyIdInfo': {'id': 'BUP-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Opioid', 'description': 'Oxycodone 5-mg oral capsule and 2 buccal placebo films', 'interventionNames': ['Drug: Oxycodone', 'Drug: Placebo Film']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose buprenorphine HCl buccal film', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule', 'interventionNames': ['Drug: Buprenorphine', 'Drug: Placebo Film', 'Drug: Placebo Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Mid Dose buprenorphine HCl buccal film', 'description': 'Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule', 'interventionNames': ['Drug: Buprenorphine', 'Drug: Placebo Film', 'Drug: Placebo Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose buprenorphine HCl buccal film', 'description': 'Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule', 'interventionNames': ['Drug: Buprenorphine', 'Drug: Placebo Film', 'Drug: Placebo Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo capsule and 2 buccal placebo films', 'interventionNames': ['Drug: Placebo Film', 'Drug: Placebo Capsule']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['Oxycodone capsule'], 'description': 'Single-dose of over-encapsulated oral 5-mg oxycodone capsule', 'armGroupLabels': ['Standard Opioid']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['BEMA Buprenorphine', 'BELBUCA', 'Buprenorphine HCl buccal film', 'Buprenorphine HCl buccal soluble film'], 'description': 'Single-dose of buprenorphine HCl buccal film', 'armGroupLabels': ['High Dose buprenorphine HCl buccal film', 'Low Dose buprenorphine HCl buccal film', 'Mid Dose buprenorphine HCl buccal film']}, {'name': 'Placebo Film', 'type': 'DRUG', 'otherNames': ['Placebo', 'Placebo buccal film', 'BEMA placebo'], 'description': 'Single-dose of placebo buccal film', 'armGroupLabels': ['High Dose buprenorphine HCl buccal film', 'Low Dose buprenorphine HCl buccal film', 'Mid Dose buprenorphine HCl buccal film', 'Placebo', 'Standard Opioid']}, {'name': 'Placebo Capsule', 'type': 'DRUG', 'otherNames': ['Placebo', 'Oxycodone placebo'], 'description': 'Single-dose of oral placebo capsule', 'armGroupLabels': ['High Dose buprenorphine HCl buccal film', 'Low Dose buprenorphine HCl buccal film', 'Mid Dose buprenorphine HCl buccal film', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Donald P. Bandy, DDS', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David Blum, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioDelivery Sciences International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioDelivery Sciences International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}