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

This study has been terminated.
(due to administrative reasons not related to efficacy or safety.)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00403234
First received: November 21, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Buprenorphine transdermal patch
Drug: Placebo BTDS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: From signed informed consent to 7 days after end of study (approx. 35 days) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 10
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTDS 10
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Other Name: Butrans™
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Other Name: Butrans™
Experimental: BTDS 30
Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo TDS
Placebo patches were similar to BTDS 10 and 20.
Drug: Placebo BTDS
Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403234

Locations
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Accurate Clinical Trials, Inc
San Clemente, California, United States, 92672
United States, Florida
Southeastern Clinical Research Consultants
Orlando, Florida, United States, 32804
United States, Maryland
Greater Chesapeake Orthopaedic Associates
Baltimore, Maryland, United States, 21218
United States, Pennsylvania
Sewickley Valley Hospital
Sewickley, Pennsylvania, United States, 15143
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00403234     History of Changes
Other Study ID Numbers: BUP2003
Study First Received: November 21, 2006
Results First Received: July 28, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Postoperative pain
opioid
transdermal
TKA (total knee arthroplasty)

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014