Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-04 @ 3:53 PM
Study NCT ID:
NCT00312195
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2006-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-733-1333', 'title': 'Clinical Leader, Executive Medical Director', 'organization': 'Purdue Pharma L.P.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.', 'description': 'Adverse Events were learned of through spontaneous reports and subject interview.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.', 'otherNumAtRisk': 138, 'otherNumAffected': 21, 'seriousNumAtRisk': 138, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.', 'otherNumAtRisk': 129, 'otherNumAffected': 25, 'seriousNumAtRisk': 129, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Open-label Run-in Period BTDS 5, 10 or 20', 'description': 'Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.', 'otherNumAtRisk': 588, 'otherNumAffected': 245, 'seriousNumAtRisk': 588, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Headache', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Asthenia', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Nausea', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 112}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Vomit', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Dizziness', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Somnolence', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Erythema at site', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 43}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Pruritus at site', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 588, 'numAffected': 58}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}], 'seriousEvents': [{'term': 'Pain abdominal', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Abscess', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Injury accidental', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Cellulitis', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Pain, chest', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Fibrillation, atrial', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Gastroenteritis', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Dehydration', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}, {'term': 'Depression', 'notes': 'Systematic and nonsystematic assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 588, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART (5.0)'}], 'frequencyThreshold': '4.50'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'OG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Placebo and BTDS combined.'}], 'classes': [{'title': 'Subjects With Ineffective Treatment', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}]}, {'title': 'Reason: took more than 1 gram of acetaminophen/day', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}, {'title': 'Reason: required a change in TDS dose', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Reason: difficulty keeping patch on', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Reason: discontinued due to ineffective treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.0217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.95', 'pValueComment': 'P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.2544', 'estimateComment': 'Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.', 'groupDescription': 'H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Double-blind phase (14 days)', 'description': 'Ineffective treatment was defined as:\n\n* Subject took \\>1 gram of acetaminophen in a 24-hour period, or\n* Subject required a change in transdermal patch (TDS) dose, or\n* Subject had difficulty in keeping the TDS on, or\n* Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).\n\nNote: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.'}, {'type': 'SECONDARY', 'title': 'Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'OG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The time of ineffective treatment was calculated as the earliest of the following:\n\n* The date the subject first took \\>1 gram of acetaminophen,\n* The visit date when ineffective treatment was first determined, or\n* The date the last patch was removed.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'OG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.'}], 'classes': [{'title': "Subjects w/ineffective treatment or who discont'd", 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Ineffective Treatment', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to other reasons', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Note: The total numbers of "Subjects w/ineffective treatment or who discont\'d" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.'}, {'type': 'SECONDARY', 'title': 'The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'OG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.', 'unitOfMeasure': 'Tablets', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'FG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.', 'preAssignmentDetails': 'The Run-in period (N = 588 subjects started) consisted of titration from buprenorphine transdermal patch (BTDS) 5 to BTDS 10, or 20 mcg/h for tolerability. If BTDS was not tolerated or pain increased, the subject was discontinued. N = 267 subjects were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind Placebo Patch', 'description': 'Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'BG001', 'title': 'Double-blind BTDS', 'description': 'Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '11.48', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '13.34', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '12.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2006-04-05', 'resultsFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2006-04-06', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-28', 'studyFirstPostDateStruct': {'date': '2006-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.', 'timeFrame': 'Double-blind phase (14 days)', 'description': 'Ineffective treatment was defined as:\n\n* Subject took \\>1 gram of acetaminophen in a 24-hour period, or\n* Subject required a change in transdermal patch (TDS) dose, or\n* Subject had difficulty in keeping the TDS on, or\n* Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).\n\nNote: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.'}], 'secondaryOutcomes': [{'measure': 'Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment', 'timeFrame': '14 days', 'description': 'The time of ineffective treatment was calculated as the earliest of the following:\n\n* The date the subject first took \\>1 gram of acetaminophen,\n* The visit date when ineffective treatment was first determined, or\n* The date the last patch was removed.'}, {'measure': 'The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase', 'timeFrame': '14 days', 'description': 'Note: The total numbers of "Subjects w/ineffective treatment or who discont\'d" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.'}, {'measure': 'The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).', 'timeFrame': '14 days', 'description': 'The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.'}]}, 'conditionsModule': {'keywords': ['Chronic pain', 'opioid', 'transdermal', 'Butrans™ [BTDS]'], 'conditions': ['Chronic Non-malignant Pain']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.', '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': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.\n* Good, very good or excellent pain control on current opioid therapy.\n* Willing and able to use a telephone interactive voice response service.\n\nExclusion Criteria:\n\n* Currently receiving daily morphine or oxycodone monotherapy.\n* Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.\n\nOther protocol-specific exclusion/inclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00312195', 'briefTitle': 'Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes', 'orgStudyIdInfo': {'id': 'BUP3201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTDS (5, 10 or 20)', 'description': 'Buprenorphine transdermal patch', 'interventionNames': ['Drug: Buprenorphine transdermal patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to match BTDS', 'description': 'Placebo to match buprenorphine transdermal patch', 'interventionNames': ['Drug: Placebo to match BTDS']}], 'interventions': [{'name': 'Buprenorphine transdermal patch', 'type': 'DRUG', 'otherNames': ['Butrans™'], 'description': 'Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.', 'armGroupLabels': ['BTDS (5, 10 or 20)']}, {'name': 'Placebo to match BTDS', 'type': 'DRUG', 'description': 'Placebo to match buprenorphine transdermal patch applied for 7-day wear.', 'armGroupLabels': ['Placebo to match BTDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hawthorne and York', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center Inc', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06611', 'city': 'Trumbull', 'state': 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