Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement

Phase 2

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: Buprenorphine transdermal patch; Drug: Placebo BTDS

• Registration Number: NCT00403234
• Lead Sponsor: Purdue Pharma LP

Brief Summary

The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.

Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became 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: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2007-04
• Study Completion: 2007-08
• 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: 10

Inclusion Criteria

• Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
• Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.

Exclusion Criteria

• Subjects who have pain or disability in a site other than the operative joint.
• Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
• Subjects whose body mass index (BMI) is 40 or more.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTDS 10	Buprenorphine transdermal patch	Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
BTDS 20	Buprenorphine transdermal patch	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Placebo TDS	Placebo BTDS	Placebo patches were similar to BTDS 10 and 20.
BTDS 30	Buprenorphine transdermal patch	Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) as a Measure of Safety	From signed informed consent to 7 days after end of study (approx. 35 days)	Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.

Trial Locations

Locations (5)

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

Greater Chesapeake Orthopaedic Associates; 🇺🇸 Baltimore, Maryland, United States

Southeastern Clinical Research Consultants; 🇺🇸 Orlando, Florida, United States

Accurate Clinical Trials, Inc; 🇺🇸 San Clemente, California, United States

Sewickley Valley Hospital; 🇺🇸 Sewickley, Pennsylvania, United States