A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
Overview
- Phase
- Phase 3
- Intervention
- Buprenorphine transdermal patch
- Conditions
- Back Pain Lower Back Chronic
- Sponsor
- Purdue Pharma LP
- Enrollment
- 354
- Locations
- 81
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) as a Measure of Safety
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS
- •NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase
Exclusion Criteria
- •Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.
Arms & Interventions
BTDS
Buprenorphine transdermal patch
Intervention: Buprenorphine transdermal patch
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time Frame: 52-week extension phase
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).