Status:
COMPLETED
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects w...
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 diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
Exclusion
- ingest opioid analgesics on a daily basis.
- ingest \>2500 milligrams (mg) acetaminophen on a daily basis.
- require \<20 mg or \>80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT00313846
Start Date
April 1 2003
End Date
June 1 2004
Last Update
September 3 2012
Active Locations (44)
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1
Vista Medical Research
Mesa, Arizona, United States, 85206
2
Arizona Research Center
Phoenix, Arizona, United States, 85012
3
Radiant Research
Phoenix, Arizona, United States, 85013
4
Arizona Research Center
Phoenix, Arizona, United States, 85023