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Sponsored by: |
Purdue Pharma LP |
---|---|
Information provided by: | Purdue Pharma LP |
ClinicalTrials.gov Identifier: | NCT00403234 |
The objectives in this study are to evaluate: (1) efficacy of BTDS on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: Buprenorphine Transdermal Delivery System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty |
Estimated Enrollment: | 160 |
Study Start Date: | November 2006 |
Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Accurate Clinical Trials, Inc | |
San Clemente, California, United States, 92672 | |
United States, Florida | |
Southeastern Clinical Research Consultants | |
Orlando, Florida, United States, 32804 | |
United States, Maryland | |
Greater Chesapeake Orthopaedic Associates | |
Baltimore, Maryland, United States, 21218 |
Study ID Numbers: | BUP2003 |
Study First Received: | November 21, 2006 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00403234 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Postoperative pain opioid transdermal TKA |
Signs and Symptoms Buprenorphine Postoperative Complications Narcotic Antagonists Central Nervous System Depressants Narcotics |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid Pain, Postoperative |
Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pain Pharmacologic Actions Signs and Symptoms Buprenorphine Pathologic Processes |
Postoperative Complications Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative Analgesics, Opioid |