Status:
COMPLETED
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with ost...
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
- \- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
Exclusion
- currently have condition requiring a stable regimen of acetaminophen (APAP).
- a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00312572
Start Date
June 1 2003
End Date
July 1 2004
Last Update
September 3 2012
Active Locations (36)
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1
Southern Drug Research
Birmingham, Alabama, United States, 35007
2
Redpoint Research
Phoenix, Arizona, United States, 85029
3
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
4
Tucson Orthopedic Institute
Tucson, Arizona, United States, 85712