Status:
COMPLETED
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate re...
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
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
- taking \>/=3 opioid doses per day with or without acceptable pain control.
Exclusion
- receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
November 1 1996
Trial Type :
INTERVENTIONAL
End Date :
December 1 1999
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00315848
Start Date
November 1 1996
End Date
December 1 1999
Last Update
May 3 2006
Active Locations (10)
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1
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
2
Arizona Research and Education
Phoenix, Arizona, United States, 85012
3
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
4
Western Integrated Pain Treatment Centers
Westminster, Colorado, United States, 80030