Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
1 other identifier
interventional
204
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2003
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 10, 2006
CompletedResults Posted
Study results publicly available
September 23, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.1 years
April 7, 2006
July 29, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
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).
14 days
Study Arms (2)
BTDS10/20
EXPERIMENTALInitial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.
BTDS 20
EXPERIMENTALInitial doses (Level 1) of BTDS 20.
Interventions
Buprenorphine transdermal patch applied for 7-day wear.
Eligibility Criteria
You may qualify if:
- \- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (36)
Southern Drug Research
Birmingham, Alabama, 35007, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Tucson Orthopedic Institute
Tucson, Arizona, 85712, United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, 71913, United States
Private Practice
Pine Bluff, Arkansas, 71603, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Lovelace Scientific Resources
Beverly Hills, California, 90211, United States
Southbay Pharma Research
Buena Park, California, 90620, United States
Community Medical Providers
Clovis, California, 93611, United States
Kaiser Permanente
Escondido, California, 92025, United States
Univ. of Southern California
Santa Monica, California, 90404, United States
Arthritis Center of CT
Waterbury, Connecticut, 06708, United States
Lifespan Research Foundation, Inc.
Miami, Florida, 33186, United States
Miami Beach Anesthesiology Associates
Miami Beach, Florida, 33140, United States
Neuro Science and Spine Assoc.
Naples, Florida, 34102, United States
West Broward Rheumatology Association, Inc.
Tamarac, Florida, 33321, United States
Intermountain Orthopaedics
Boise, Idaho, 83702, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Bluegrass Orthopaedics
Lexington, Kentucky, 40509, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Dolby Providers, Inc.
New Orleans, Louisiana, 70128, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Westside Family Medical Center
Kalamazoo, Michigan, 49009, United States
PCM Medical Services
Lansing, Michigan, 48917, United States
HealthCare Research LLC
St Louis, Missouri, 63141, United States
Northeast Pain Research Center
Barrington, New Hampshire, 03825, United States
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Dayton Primary and Urgent Care
Dayton, Ohio, 45402, United States
The Medford Medical Clinic
Medford, Oregon, 97504, United States
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118, United States
CEDRA Clinical Research,
Austin, Texas, 78759, United States
Renaissance Clinical Research & Hypertension Clinic
Dallas, Texas, 75235, United States
Spine Care Southwest.
Houston, Texas, 77074, United States
KRK Medical Research
Richardson, Texas, 75080, United States
Monroe Medical Foundation
Monroe, Wisconsin, 53566, United States
Related Publications (1)
Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.
PMID: 22409388RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 10, 2006
Study Start
June 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
September 3, 2012
Results First Posted
September 23, 2010
Record last verified: 2012-08