Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00315835
Status:
COMPLETED
Last Update Posted:
2006-04-19
First Post:
2006-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-10'}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '1997-11'}, 'lastUpdateSubmitDate': '2006-04-17', 'studyFirstSubmitDate': '2006-04-17', 'studyFirstSubmitQcDate': '2006-04-17', 'lastUpdatePostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical laboratory tests'}, {'measure': 'vital signs'}, {'measure': 'physical examinations'}, {'measure': 'electrocardiograms'}, {'measure': 'elicited opioid side effects'}, {'measure': 'pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)'}, {'measure': 'adverse events'}, {'measure': 'application site skin observations'}, {'measure': 'plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination'}], 'secondaryOutcomes': [{'measure': 'pain intensity'}, {'measure': 'acceptability of therapy'}, {'measure': 'quality of sleep'}, {'measure': 'rescue dose usage'}]}, 'conditionsModule': {'keywords': ['postoperative pain', 'opioid', 'transdermal'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.', 'detailedDescription': 'Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \\>/=4 days postoperatively.\n* in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \\>/=4 days post-surgery.\n\nExclusion Criteria:\n\n* receiving chronic opioid therapy preoperatively for \\>1 month that was at a total daily dose of \\>/= 60 mg of oral morphine equivalents.\n* have significant concurrent pulmonary conditions.\n\nOther protocol-specific exclusion/inclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00315835', 'briefTitle': 'Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'BP96-0104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Buprenorphine transdermal delivery system', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Park Place Therapeutic Center', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue Pharma LP', 'class': 'INDUSTRY'}}}}