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Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Placebo transdermal patch
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, opioid, transdermal

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids. taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain. Exclusion Criteria: requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine. scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/inclusion criteria may apply.

Sites / Locations

  • Parkway Medical Center
  • Clinical Research Consultants
  • Winston Physician Services, Inc
  • Private Practice
  • Clinic for Rheumatic Diseases
  • Radiant Research
  • Arizona Research Center
  • ACRC/Arizona Clinical Research
  • University of Arkansas for Medical Sciences
  • Southbay Pharma Research
  • Torrence Clinical Research
  • Comprehensive Neuroscience Inc
  • Chiefland Medical Center
  • University Clinical Research Deland
  • Florida Medical Research Institute
  • Drug Study Institute
  • Coastal Medical Research
  • Ormond Medical Arts Pharmaceutical Res Ctr
  • The Arthritis Center
  • Avancia Research
  • Coastal Medical Research
  • Palm Beach Research Center
  • Gold Coast Research LLC
  • Georgia Medical Research Institute
  • Internal Medicine Northwest
  • MediSphere Medical Research Center
  • University of Louisville Medical/Rheumatology
  • Clinical Trials Management, LLC
  • Future Care Studies
  • Bay Area Health Clinic
  • Medex Healthcare Research Inc
  • Beth Israel Medical Center
  • Health Research Institute
  • Keystone Clinical Solutions
  • Altoona Center for Clinical Research
  • BioMedical Research Associates
  • University Orthopedics Center
  • Omega Medical Research
  • Low Country Rheumatology
  • Brown Clinic
  • Holston Medical Group
  • CSS Research
  • Prime Care Medical Center
  • Team Research of Central Texas
  • Quality Research
  • Advanced Pain Management and Rehab Hilltop Med Center
  • Sentara Medical Group
  • Physicians Clinic of Spokane

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTDS

Placebo

Arm Description

Buprenorphine transdermal patches 10 or 20 mcg/h

Placebo to match buprenorphine transdermal patch 10 or 20

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) as a Measure of Safety
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2006
Last Updated
August 27, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00315458
Brief Title
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons.
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (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 original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the 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
Osteoarthritis
Keywords
osteoarthritis, opioid, transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patches 10 or 20 mcg/h
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match buprenorphine transdermal patch 10 or 20
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal patch
Intervention Description
Placebo to match buprenorphine transdermal patch 10 or 20.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Description
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
Time Frame
483 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids. taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain. Exclusion Criteria: requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine. scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Facility Information:
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Clinical Research Consultants
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Winston Physician Services, Inc
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Private Practice
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Clinic for Rheumatic Diseases
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Radiant Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
ACRC/Arizona Clinical Research
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southbay Pharma Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Torrence Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Comprehensive Neuroscience Inc
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Chiefland Medical Center
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
University Clinical Research Deland
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Coastal Medical Research
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Res Ctr
City
Ormond Beach,
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Avancia Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Coastal Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Gold Coast Research LLC
City
Weston
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Georgia Medical Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Internal Medicine Northwest
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
MediSphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
University of Louisville Medical/Rheumatology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Bay Area Health Clinic
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Medex Healthcare Research Inc
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Keystone Clinical Solutions
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
BioMedical Research Associates
City
Shippensburg
State/Province
Pennsylvania
ZIP/Postal Code
17257
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Low Country Rheumatology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Brown Clinic
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
CSS Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Prime Care Medical Center
City
Selmer
State/Province
Tennessee
ZIP/Postal Code
38375
Country
United States
Facility Name
Team Research of Central Texas
City
Harker Heights
State/Province
Texas
ZIP/Postal Code
76548
Country
United States
Facility Name
Quality Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Advanced Pain Management and Rehab Hilltop Med Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Sentara Medical Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Physicians Clinic of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
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

Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

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