Safety & Efficacy of Buprenorphine Transdermal Delivery System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement - Full Text View

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00403234

Purpose

The objectives in this study are to evaluate: (1) efficacy of BTDS 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.

Condition	Intervention	Phase
Postoperative Pain	Drug: Buprenorphine Transdermal Delivery System	Phase II

MedlinePlus related topics: Knee Replacement Surgery

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

The cumulative amount of PCA morphine(mg)
Pain intensity difference
Average Pain in the last 24 hours

Secondary Outcome Measures:

Knee Society Functional Score
Pain and functional sub-scores from the WOMAC OA Index
Mean total daily rescue use

Estimated Enrollment:	160
Study Start Date:	November 2006
Study Completion Date:	August 2007

Detailed Description:

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

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 ASA physical status classification of 1, 2 or 3
Scheduled to undergo unilateral 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 BMI is 40 or more.

Contacts and Locations

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

Locations

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

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BUP2003
Study First Received:	November 21, 2006
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00403234 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Postoperative pain
opioid
transdermal
TKA

Study placed in the following topic categories:

Signs and Symptoms
Buprenorphine
Postoperative Complications
Narcotic Antagonists
Central Nervous System Depressants
Narcotics

Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid
Pain, Postoperative

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Buprenorphine
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009