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

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Placebo BTDS
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Research Center
  • Accurate Clinical Trials, Inc
  • Southeastern Clinical Research Consultants
  • Greater Chesapeake Orthopaedic Associates
  • Sewickley Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BTDS 10

BTDS 20

BTDS 30

Placebo TDS

Arm Description

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear

Placebo patches were similar to BTDS 10 and 20.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2006
Last Updated
August 27, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00403234
Brief Title
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
due to administrative reasons not related to efficacy or safety.
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS 10
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Arm Title
BTDS 20
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Arm Title
BTDS 30
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear
Arm Title
Placebo TDS
Arm Type
Placebo Comparator
Arm Description
Placebo patches were similar to BTDS 10 and 20.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Placebo BTDS
Intervention Description
Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Accurate Clinical Trials, Inc
City
San Clemente
State/Province
California
ZIP/Postal Code
92672
Country
United States
Facility Name
Southeastern Clinical Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Greater Chesapeake Orthopaedic Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Sewickley Valley Hospital
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States

12. IPD Sharing Statement

Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information

Learn more about this trial

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

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