Status:
COMPLETED
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 assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis ...
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
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
Exclusion
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 1999
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00314652
Start Date
June 1 1999
End Date
October 1 1999
Last Update
May 3 2006
Active Locations (22)
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1
Hawthorne & York, International, Ltd.
Phoenix, Arizona, United States, 85008
2
Arizona Research Center, LLC
Phoenix, Arizona, United States, 85023
3
ACRC/Arizona Clinical Research
Tucson, Arizona, United States, 85712
4
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712