Status:
TERMINATED
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycod...
Detailed Description
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 rel...
Eligibility Criteria
Inclusion
- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
Exclusion
- Not currently taking and tolerating opioids.
- Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00312221
Start Date
April 1 2004
End Date
August 1 2005
Last Update
September 10 2012
Active Locations (23)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
International Clinical Research Network
Chula Vista, California, United States, 91910
3
Clinical Trials Research
Roseville, California, United States, 95661
4
Accelovance
San Diego, California, United States, 92108