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

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ClinicalTrials.gov Identifier: NCT00403234
Recruitment Status : Terminated (due to administrative reasons not related to efficacy or safety.)
First Posted : November 23, 2006
Results First Posted : September 21, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Buprenorphine transdermal patch Drug: Placebo BTDS Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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) ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00403234     History of Changes
Other Study ID Numbers: BUP2003
First Posted: November 23, 2006    Key Record Dates
Results First Posted: September 21, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012

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

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