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

Phase 2TerminatedNCT00403234

Purdue Pharma LP10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (5)

Arizona Research Center

Phoenix, Arizona, United States

Accurate Clinical Trials, Inc

San Clemente, California, United States

Southeastern Clinical Research Consultants

Orlando, Florida, United States

Greater Chesapeake Orthopaedic Associates

Baltimore, Maryland, United States

Sewickley Valley Hospital

Sewickley, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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.

Time frame: From signed informed consent to 7 days after end of study (approx. 35 days)