Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Phase 3

Terminated

• Conditions: Osteoarthritis
• Interventions: Drug: Buprenorphine transdermal patch

• 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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Results First Submitted: 2010-07-15
• Results First Submitted QC: 2010-08-30
• Results First Posted: 2010-09-23
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 196

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.

Exclusion Criteria

• 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.

Trial Locations

Locations (26)

Alabama Neurology and Pain Medicine; 🇺🇸 Alabaster, Alabama, United States

Research Facility; 🇺🇸 New Berlin, Wisconsin, United States

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

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

HealthSouth Metro West Hospital; 🇺🇸 Fairfield, Alabama, United States

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

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

NTOUCH Research Corporation; 🇺🇸 San Diego, California, United States

Radiant Research; 🇺🇸 Greer, South Carolina, United States

Idaho Arthritis Osteoporosis; 🇺🇸 Meridian, Idaho, United States

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