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:
Purdue Pharma LP
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
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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 May 16, 2013