Status:
COMPLETED
Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
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
- Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
Exclusion
- Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
- Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.
- Refer to core study for additional inclusion/exclusion information.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01141283
Start Date
April 1 2003
End Date
July 1 2004
Last Update
September 3 2012
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Vista Medical Research Inc.
Mesa, Arizona, United States, 85206
2
Arthrocare, Arthritis Care and Research
Phoenix, Arizona, United States, 85012
3
Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
Phoenix, Arizona, United States, 85015
4
Arizona Research Center
Phoenix, Arizona, United States, 85023