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Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

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ClinicalTrials.gov Identifier: NCT00312572
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : September 23, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine transdermal patch Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
Study Start Date : June 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™

Experimental: BTDS 20
Initial doses (Level 1) of BTDS 20.
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312572


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Locations
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United States, Alabama
Southern Drug Research
Birmingham, Alabama, United States, 35007
United States, Arizona
Redpoint Research
Phoenix, Arizona, United States, 85029
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
Tucson Orthopedic Institute
Tucson, Arizona, United States, 85712
United States, Arkansas
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, United States, 71913
Private Practice
Pine Bluff, Arkansas, United States, 71603
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Lovelace Scientific Resources
Beverly Hills, California, United States, 90211
Southbay Pharma Research
Buena Park, California, United States, 90620
Community Medical Providers
Clovis, California, United States, 93611
Kaiser Permanente
Escondido, California, United States, 92025
Univ. of Southern California
Santa Monica, California, United States, 90404
United States, Connecticut
Arthritis Center of CT
Waterbury, Connecticut, United States, 06708
United States, Florida
Miami Beach Anesthesiology Associates
Miami Beach, Florida, United States, 33140
Lifespan Research Foundation, Inc.
Miami, Florida, United States, 33186
Neuro Science and Spine Assoc.
Naples, Florida, United States, 34102
West Broward Rheumatology Association, Inc.
Tamarac, Florida, United States, 33321
United States, Idaho
Intermountain Orthopaedics
Boise, Idaho, United States, 83702
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Bluegrass Orthopaedics
Lexington, Kentucky, United States, 40509
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Dolby Providers, Inc.
New Orleans, Louisiana, United States, 70128
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
PCM Medical Services
Lansing, Michigan, United States, 48917
United States, Missouri
HealthCare Research LLC
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Northeast Pain Research Center
Barrington, New Hampshire, United States, 03825
United States, North Carolina
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
United States, Ohio
Dayton Primary and Urgent Care
Dayton, Ohio, United States, 45402
United States, Oregon
The Medford Medical Clinic
Medford, Oregon, United States, 97504
United States, South Carolina
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, United States, 29118
United States, Texas
CEDRA Clinical Research,
Austin, Texas, United States, 78759
Renaissance Clinical Research & Hypertension Clinic
Dallas, Texas, United States, 75235
Spine Care Southwest.
Houston, Texas, United States, 77074
KRK Medical Research
Richardson, Texas, United States, 75080
United States, Wisconsin
Monroe Medical Foundation
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Purdue Pharma LP

Additional Information:
Publications of Results:
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Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312572     History of Changes
Other Study ID Numbers: BUP3018
First Posted: April 10, 2006    Key Record Dates
Results First Posted: September 23, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Purdue Pharma LP:
Osteoarthritis, opioid, transdermal
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen, hydrocodone drug combination
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents