Status:
TERMINATED
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
Lead Sponsor:
Purdue Pharma LP
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to ...
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 who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
Exclusion
- Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
- Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
- 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 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01135524
Start Date
April 1 2004
End Date
August 1 2005
Last Update
September 10 2012
Active Locations (89)
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1
Alabama Neurology and Pain Medicine
Alabaster, Alabama, United States, 35007
2
Research Facility
Birmingham, Alabama, United States, 35215
3
The Birmingham Pain Center
Birmingham, Alabama, United States, 35244
4
University of Alabama Hospital
Birmingham, Alabama, United States, 35249