Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
- Registration Number
- NCT01135524
- Lead Sponsor
- Purdue Pharma LP
- 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 achieve stable pain control.
- 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 moderate to severe pain.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 196
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BTDS Buprenorphine transdermal patch Buprenorphine transdermal patch
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events as a Measure of Safety and Tolerability 52 weeks Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
HealthCare Research LLC
🇺🇸St. Louis, Missouri, United States
Louisville Endocrinology PSC
🇺🇸Louisville, Kentucky, United States
Alabama Neurology and Pain Medicine
🇺🇸Alabaster, Alabama, United States
Rheumatology PC
🇺🇸Kalamazoo, Michigan, United States
Family Practice Associates
🇺🇸Corpus Christi, Texas, United States
HealthSouth Metro West Hospital
🇺🇸Fairfield, Alabama, United States
Integrated Clinical Trials
🇺🇸West Des Moines, Iowa, United States
New England Center for Clinical Research
🇺🇸Cranston, Rhode Island, United States
Crystal Lake Health Center
🇺🇸Benzonia, Michigan, United States
The Arthritis Clinic and Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
Cornerstone Research Care
🇺🇸High Point, North Carolina, United States
Idaho Arthritis Osteoporosis
🇺🇸Meridian, Idaho, United States
The Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
NTOUCH Research Corporation
🇺🇸San Diego, California, United States
Triangle Orthopaedic Associates
🇺🇸Durham, North Carolina, United States
Research Facility
🇺🇸New Berlin, Wisconsin, United States
Patuxent Medical Group
🇺🇸Columbia, Maryland, United States
KC Pain Centers East
🇺🇸Independence, Missouri, United States
The Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Allergy ARTS
🇺🇸Amarillo, Texas, United States
KRK Medical Research
🇺🇸Richardson, Texas, United States
Hot Springs Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Dolby Providers
🇺🇸New Orleans, Louisiana, United States
Radiant Research
🇺🇸Greer, South Carolina, United States