Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Phase 3

Terminated

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

• Registration Number: NCT00320801
• Lead Sponsor: Purdue Pharma LP

Brief Summary

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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: 2004-01
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Study First Posted: 2006-05-03
• Results First Submitted: 2010-07-28
• Results First Submitted QC: 2010-08-23
• Results First Posted: 2010-09-20
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• osteoarthritis of the hip, knee, or spine for 1 year or longer.
• taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

Exclusion Criteria

• taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTDS 5	Buprenorphine transdermal patch	Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
BTDS 20	Buprenorphine transdermal patch	Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.	Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)	Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).

Trial Locations

Locations (61)

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

Edwards Lake Medical Center; 🇺🇸 Birmingham, Alabama, United States

Rheumatogogy Associates of N. Alabama,; 🇺🇸 Huntsville, Alabama, United States

Drug Research and Analysis Corp.; 🇺🇸 Montgomery, Alabama, United States

Meadowbrook Research; 🇺🇸 Scottsdale, Arizona, United States

Research Solutions, LLC; 🇺🇸 Searcy, Arizona, United States

Central Arkansas Research; 🇺🇸 Hot Springs, Arkansas, United States

Crest Clinical Research, Inc; 🇺🇸 Anaheim, California, United States

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

Orange County Clinical Research; 🇺🇸 Cypress, California, United States

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