Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

Phase 3

Terminated

• Conditions: Back Pain Lower Back Chronic
• Interventions: Drug: Buprenorphine transdermal patch

• Registration Number: NCT01125917
• Lead Sponsor: Purdue Pharma LP

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-09
• Study Completion: 2008-01
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Results First Submitted: 2010-07-28
• Results First Submitted QC: 2010-08-25
• Results First Posted: 2010-09-21
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 354

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 20. 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.

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
Number of Participants With Adverse Events (AEs) as a Measure of Safety	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).

Trial Locations

Locations (81)

Birmingham Pain Center; 🇺🇸 Birmingham, Alabama, United States

Arthritis Clinical Intervention Program; 🇺🇸 Birmingham, Alabama, United States

Winston Physician Services, Inc; 🇺🇸 Haleyville, Alabama, United States

Arizona Research Center Inc; 🇺🇸 Phoenix, Arizona, United States

Radiant Research; 🇺🇸 Phoenix, Arizona, United States

Advanced Clinical Therapeutics; 🇺🇸 Tucson, Arizona, United States

Hot Springs Pain Clinic; 🇺🇸 Hot Springs, Arkansas, United States

NuLife Clinical Research, Inc.; 🇺🇸 Anaheim, California, United States

Lovelace Scientific Resources; 🇺🇸 Henderson, Nevada, United States

Northern California Research Corp; 🇺🇸 Carmichael, California, United States

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