Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Postoperative Pain
In brief
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) 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. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
Key facts
- Study ID
- NCT00403234
- Run by
- Purdue Pharma LP
- People needed
- 10
- Starts
- 2006-11-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2012-09-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
- Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
You may not qualify if…
- Subjects who have pain or disability in a site other than the operative joint.
- Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
- Subjects whose body mass index (BMI) is 40 or more.
Where it is running
- Arizona Research Center — Phoenix, Arizona, United States
- Accurate Clinical Trials, Inc — San Clemente, California, United States
- Southeastern Clinical Research Consultants — Orlando, Florida, United States
- Greater Chesapeake Orthopaedic Associates — Baltimore, Maryland, United States
- Sewickley Valley Hospital — Sewickley, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.