Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
August 27, 2012 updated by: Purdue Pharma LP
A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee.
The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35007
- Southern Drug Research
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Arizona
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Phoenix, Arizona, United States, 85029
- Redpoint Research
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Tucson, Arizona, United States, 85712
- Advanced Clinical Therapeutics
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Tucson, Arizona, United States, 85712
- Tucson Orthopedic Institute
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Hot Springs Mercy Pain Clinic
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Pine Bluff, Arkansas, United States, 71603
- Private Practice
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
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Beverly Hills, California, United States, 90211
- Lovelace Scientific Resources
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Buena Park, California, United States, 90620
- Southbay Pharma Research
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Clovis, California, United States, 93611
- Community Medical Providers
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Escondido, California, United States, 92025
- Kaiser Permanente
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Santa Monica, California, United States, 90404
- Univ. of Southern California
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Arthritis Center of CT
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Florida
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Miami, Florida, United States, 33186
- Lifespan Research Foundation, Inc.
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Miami Beach, Florida, United States, 33140
- Miami Beach Anesthesiology Associates
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Naples, Florida, United States, 34102
- Neuro Science and Spine Assoc.
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Tamarac, Florida, United States, 33321
- West Broward Rheumatology Association, Inc.
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Idaho
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Boise, Idaho, United States, 83702
- Intermountain Orthopaedics
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40509
- Bluegrass Orthopaedics
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Madisonville, Kentucky, United States, 42431
- Commonwealth Biomedical Research, LLC
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Louisiana
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New Orleans, Louisiana, United States, 70128
- Dolby Providers, Inc.
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Massachusetts
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Worcester, Massachusetts, United States, 01610
- Clinical Pharmacology Study Group
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Michigan
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Kalamazoo, Michigan, United States, 49009
- Westside Family Medical Center
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Lansing, Michigan, United States, 48917
- PCM Medical Services
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Missouri
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St. Louis, Missouri, United States, 63141
- HealthCare Research LLC
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New Hampshire
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Barrington, New Hampshire, United States, 03825
- Northeast Pain Research Center
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North Carolina
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Charlotte, North Carolina, United States, 28210
- The Arthritis Clinic and Carolina Bone and Joint
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Ohio
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Dayton, Ohio, United States, 45402
- Dayton Primary and Urgent Care
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Oregon
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Medford, Oregon, United States, 97504
- The Medford Medical Clinic
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South Carolina
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Orangeburg, South Carolina, United States, 29118
- The Arthritis and Osteoporosis Center
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Texas
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Austin, Texas, United States, 78759
- CEDRA Clinical Research,
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Dallas, Texas, United States, 75235
- Renaissance Clinical Research & Hypertension Clinic
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Houston, Texas, United States, 77074
- Spine Care Southwest.
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Richardson, Texas, United States, 75080
- KRK Medical Research
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Wisconsin
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Monroe, Wisconsin, United States, 53566
- Monroe Medical Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
Exclusion Criteria:
- currently have condition requiring a stable regimen of acetaminophen (APAP).
- a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
Other protocol-specific exclusion/inclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: BTDS10/20
Initial doses (Level 1) of BTDS 10.
Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.
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Buprenorphine transdermal patch applied for 7-day wear.
Other Names:
|
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EXPERIMENTAL: BTDS 20
Initial doses (Level 1) of BTDS 20.
|
Buprenorphine transdermal patch applied for 7-day wear.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
Time Frame: 14 days
|
The indicator variable was 1 = completion, and 0 = noncompletion.
For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).
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14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (ACTUAL)
July 1, 2004
Study Completion (ACTUAL)
July 1, 2004
Study Registration Dates
First Submitted
April 7, 2006
First Submitted That Met QC Criteria
April 7, 2006
First Posted (ESTIMATE)
April 10, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 3, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUP3018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.