Status:
TERMINATED
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with m...
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
- clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
- taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
Exclusion
- requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
- scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00315458
Start Date
December 1 2003
End Date
March 1 2005
Last Update
September 3 2012
Active Locations (48)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Clinical Research Consultants
Birmingham, Alabama, United States, 35244
3
Winston Physician Services, Inc
Haleyville, Alabama, United States, 35565
4
Private Practice
Muscle Shoals, Alabama, United States, 35661