Status:
TERMINATED
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Lead Sponsor:
Purdue Pharma LP
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 o...
Detailed Description
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 mo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00403234
Start Date
November 1 2006
End Date
August 1 2007
Last Update
September 3 2012
Active Locations (5)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85023
2
Accurate Clinical Trials, Inc
San Clemente, California, United States, 92672
3
Southeastern Clinical Research Consultants
Orlando, Florida, United States, 32804
4
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, United States, 21218