Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

Phase 3

Terminated

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

• Registration Number: NCT00315458
• Lead Sponsor: Purdue Pharma LP

Brief Summary

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

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: 2003-12
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2006-04-17
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Results First Submitted: 2010-07-28
• Results First Submitted QC: 2010-08-30
• Results First Posted: 2010-09-23
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
• taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria

• requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
• scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTDS	Buprenorphine transdermal patch	Buprenorphine transdermal patches 10 or 20 mcg/h
Placebo	Placebo transdermal patch	Placebo to match buprenorphine transdermal patch 10 or 20

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) as a Measure of Safety	483 days	For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.

Trial Locations

Locations (47)

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Consultants; 🇺🇸 Birmingham, Alabama, United States

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

Private Practice; 🇺🇸 Muscle Shoals, Alabama, United States

Clinic for Rheumatic Diseases; 🇺🇸 Tuscaloosa, Alabama, United States

Radiant Research; 🇺🇸 Phoenix, Arizona, United States

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

ACRC/Arizona Clinical Research; 🇺🇸 Tuscon, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Southbay Pharma Research; 🇺🇸 Buena Park, California, United States

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