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Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Buprenorphine 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:

  • Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.

Exclusion Criteria:

  • Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
  • Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
  • Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

Sites / Locations

  • Alabama Neurology and Pain Medicine
  • Research Facility
  • The Birmingham Pain Center
  • University of Alabama Hospital
  • HealthSouth Metro West Hospital
  • Research Facility
  • Arizona Research Center
  • Research Facility
  • Research Facility
  • Hot Springs Pain Clinic
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • NTOUCH Research Corporation
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Radiant Research
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Idaho Arthritis Osteoporosis
  • Research Facility
  • Research Facility
  • Integrated Clinical Trials
  • Louisville Endocrinology PSC
  • Research Facility
  • Research Facility
  • Research Facility
  • Dolby Providers
  • Research Facility
  • Patuxent Medical Group
  • Research Facility
  • Research Facility
  • Crystal Lake Health Center
  • Rheumatology PC
  • Research Facility
  • KC Pain Centers East
  • Research Facility
  • HealthCare Research LLC
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • The Arthritis Clinic and Carolina Bone and Joint
  • Triangle Orthopaedic Associates
  • Research Facility
  • Research Facility
  • Cornerstone Research Care
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • The Clinical Trial Center
  • Research Facility
  • New England Center for Clinical Research
  • Radiant Research
  • Allergy ARTS
  • Research Facility
  • Family Practice Associates
  • Research Facility
  • Research Facility
  • Research Facility
  • KRK Medical Research
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BTDS

Arm Description

Buprenorphine transdermal patch

Outcomes

Primary Outcome Measures

The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2010
Last Updated
September 5, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT01135524
Brief Title
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
Official Title
A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early for administrative reasons.
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 10 mcg/h applied transdermally 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 transdermally for 7-day wear.
Primary Outcome Measure Information:
Title
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. Exclusion Criteria: Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase. Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study. Refer to core study for additional inclusion/exclusion information.
Facility Information:
Facility Name
Alabama Neurology and Pain Medicine
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
Research Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
The Birmingham Pain Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
HealthSouth Metro West Hospital
City
Fairfield
State/Province
Alabama
ZIP/Postal Code
35064
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Research Facility
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Research Facility
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hot Springs Pain Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Research Facility
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Research Facility
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Research Facility
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Research Facility
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Research Facility
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
NTOUCH Research Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Research Facility
City
Torrence
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Research Facility
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Facility
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Research Facility
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Research Facility
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Facility
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Research Facility
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Research Facility
City
Jupiter
State/Province
Florida
ZIP/Postal Code
99458
Country
United States
Facility Name
Research Facility
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Research Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Facility
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Research Facility
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Research Facility
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Research Facility
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Research Facility
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Research Facility
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Research Facility
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Facility
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Research Facility
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Research Facility
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Idaho Arthritis Osteoporosis
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Research Facility
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Integrated Clinical Trials
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Louisville Endocrinology PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Facility
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Research Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Research Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Dolby Providers
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
Research Facility
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Patuxent Medical Group
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Research Facility
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Research Facility
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Crystal Lake Health Center
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
Country
United States
Facility Name
Rheumatology PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Research Facility
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
KC Pain Centers East
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Research Facility
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
HealthCare Research LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Facility
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Facility
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
The Arthritis Clinic and Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Triangle Orthopaedic Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Research Facility
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Research Facility
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Cornerstone Research Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
Facility Name
Research Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Facility
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Research Facility
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Research Facility
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Research Facility
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Allergy ARTS
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Research Facility
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Family Practice Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
KRK Medical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Research Facility
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Research Facility
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53218
Country
United States
Facility Name
Research Facility
City
New Berlin
State/Province
Wisconsin
ZIP/Postal Code
53151
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 Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

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