Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-01-04 @ 12:05 AM
Study NCT ID:
NCT00315458
Status:
TERMINATED
Last Update Posted:
2012-09-03
First Post:
2006-04-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, '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': {'phone': '800-733-1333', 'title': 'Clinical Leader, Executive Medical Director', 'organization': 'Purdue Pharma L.P.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early for administrative reasons. The efficacy data are not presented since the primary objective of this study was changed identifying it as a safety study.'}}, 'adverseEventsModule': {'timeFrame': "Subjects with AEs that were ongoing at subject's last study visit were followed until resolution or 30 days after last visit, whichever came first. AEs reported during 7 days following last visit were followed until resoultion or 30 days after last visit.", 'description': 'AEs were learned of through spontaneous reports and subject interview.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference Treatment placebo 10 or 20 applied for 7-day wear', 'otherNumAtRisk': 51, 'otherNumAffected': 14, 'seriousNumAtRisk': 51, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-blind BTDS 10/20', 'description': 'Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear', 'otherNumAtRisk': 56, 'otherNumAffected': 22, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Run-in Period', 'description': 'Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear', 'otherNumAtRisk': 159, 'otherNumAffected': 60, 'seriousNumAtRisk': 159, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Overall BTDS Exposure', 'description': 'Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.', 'otherNumAtRisk': 159, 'otherNumAffected': 82, 'seriousNumAtRisk': 159, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Constipation', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Application site pruritus', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Application site erythema', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Application site rash', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Back Pain', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Headache', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Sweating Increased', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Somnolence', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Arthralgia', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Dizziness', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Acute myocardial infarction - DEATH', 'notes': 'DEATH (systematic and nonsystematic assessments)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Cervical spinal stenosis', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Acute exacerbation of COPD', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Recurrent Major Depression', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Confusion', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Hypoglycemia', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Near Syncope', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Pleural effusion', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'Chest Pain', 'notes': 'Systematic and non-systematic assessments.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}], 'frequencyThreshold': '4.50'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Placebo', 'description': 'Reference treatment placebo 10 or 20 applied for 7-day wear'}, {'id': 'OG001', 'title': 'Double-blind BTDS', 'description': 'Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear'}, {'id': 'OG002', 'title': 'Run-in Period', 'description': 'All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.'}, {'id': 'OG003', 'title': 'Overall BTDS Exposure', 'description': 'Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'All Other Adverse Events in ≥ 4.5% of Subjects', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '483 days', 'description': 'For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference Treatment placebo 10 or 20 applied for 7-day wear'}, {'id': 'FG001', 'title': 'Double-blind BTDS 10/20', 'description': 'Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear'}, {'id': 'FG002', 'title': 'Run-in Period BTDS 5/10/20', 'description': 'All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.'}, {'id': 'FG003', 'title': 'Extension Phase BTDS 5/10/20', 'description': 'Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '159'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Did not qualify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '12-Dec-2003 (First Patient First Visit) 02-Mar-2005 (Last Patient Last Visit of Extension). At the time of early termination, 39 centers had screened subjects, 22 centers had randomized subjects to the double-blind phase.', 'preAssignmentDetails': 'All subjects (N = 159) in the run-in period received BTDS 5 for the first 3 days, titrated to BTDS 10 or 20, continued stable nonopioid analgesic regimen for osteoarthritis (OA) pain, and took oxycodone immediate-release 5-mg capsules as supplemental analgesic therapy for primary OA pain site. N = 107 completed the run-in and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference Treatment placebo 10 or 20 applied for 7-day wear'}, {'id': 'BG001', 'title': 'Double-blind BTDS', 'description': 'Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '11.36', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '9.56', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '10.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'whyStopped': 'Administrative reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2006-04-17', 'resultsFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2006-04-17', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-30', 'studyFirstPostDateStruct': {'date': '2006-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) as a Measure of Safety', 'timeFrame': '483 days', 'description': 'For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.'}]}, 'conditionsModule': {'keywords': ['osteoarthritis', 'opioid', 'transdermal'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.', 'detailedDescription': 'Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.\n* taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.\n\nExclusion Criteria:\n\n* requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.\n* scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.\n\nOther protocol-specific exclusion/inclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00315458', 'briefTitle': 'Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.', 'nctIdAliases': ['NCT01137279'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids', 'orgStudyIdInfo': {'id': 'BUP3011 and BUP3011S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTDS', 'description': 'Buprenorphine transdermal patches 10 or 20 mcg/h', 'interventionNames': ['Drug: Buprenorphine transdermal patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to match buprenorphine transdermal patch 10 or 20', 'interventionNames': ['Drug: Placebo transdermal patch']}], 'interventions': [{'name': 'Buprenorphine transdermal patch', 'type': 'DRUG', 'otherNames': ['Butrans™'], 'description': 'Buprenorphine 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