Status:
TERMINATED
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphin...
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, knee, or spine for 1 year or longer.
- taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
Exclusion
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00320801
Start Date
January 1 2004
End Date
March 1 2005
Last Update
September 3 2012
Active Locations (66)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Edwards Lake Medical Center
Birmingham, Alabama, United States, 35235
3
Rheumatogogy Associates of N. Alabama,
Huntsville, Alabama, United States, 35801
4
Drug Research and Analysis Corp.
Montgomery, Alabama, United States, 36106