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Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Buprenorphine transdermal patch (Drug); Buprenorphine transdermal patch (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Purdue Pharma LP

Official(s) and/or principal investigator(s):
Sarah O'Keefe, BSN, Study Chair, Affiliation: Purdue Pharma L.P., Stamford, CT

Summary

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Clinical Details

Official title: A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The Number of Participants With Adverse Events (AEs) as a Measure of Safety.

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.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- osteoarthritis of the hip, knee, or spine for 1 year or longer.

- taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at

least 4 days a week. Exclusion Criteria:

- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days

of enrollment.

- requiring frequent analgesic therapy for chronic conditions in addition to

osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.

Locations and Contacts

Edwards Lake Medical Center, Birmingham, Alabama 35235, United States

Parkway Medical Center, Birmingham, Alabama 35215, United States

Rheumatogogy Associates of N. Alabama,, Huntsville, Alabama 35801, United States

Drug Research and Analysis Corp., Montgomery, Alabama 36106, United States

Meadowbrook Research, Scottsdale, Arizona 85251, United States

Research Solutions, LLC, Searcy, Arizona 72143, United States

Central Arkansas Research, Hot Springs, Arkansas 71913, United States

Crest Clinical Research, Inc, Anaheim, California 92804, United States

NuLife Clinical Research, Inc., Anaheim, California 92805, United States

Orange County Clinical Research, Cypress, California 90630, United States

Private Practice, Laguna Hills, California 90404, United States

Andwell Research, Laguna Niguel, California 92677, United States

Valerius Medical Group & Research Center Inc., Long Beach, California 90802, United States

Anesthesiology and Pain Management, Los Gatos, California 95032, United States

Scripps Clinic Ranchro Bernardo, San Diego, California 92128, United States

Orrin M. Troum & Medical Associates, Santa Monica, California 90404, United States

Diablo Clinical Research, Walnut Creek, California 94598, United States

Private Practice, Arvada, Colorado 80005, United States

Mountainview Clinical Research, Denver, Colorado 80209, United States

Private Practice, Aventura, Florida 33180, United States

Medical Research Associates, Clearwater, Florida 33761, United States

LifeSpan Clinical Research, Miami, Florida 33186, United States

Ocala Rheumatology Research Center, Ocala, Florida 34474, United States

Sarasota Arthritis Center, Sarasota, Florida 34239, United States

University Neurology, Sarasota, Florida 34243, United States

Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies, St. Cloud, Florida 34769, United States

Wilker/Powers Center for Clinical Studies, St. Cloud, Florida 34769, United States

Pinnacle Trials, Inc., Atlanta, Georgia 30329, United States

Clinical Investigative Services Med College of Georgia, Augusta, Georgia 30912, United States

America's Doctor (SMO), Gurnee, Illinois 60031, United States

Dolby Providers, Inc., New Orleans, Louisiana 70128, United States

Professional Clinical Research, Cadillac, Michigan 49601, United States

Private Practice, Oak Park, Michigan 48237, United States

Lake Michigan Clinical Research and Consulting, Inc., St. Joseph, Michigan 49085, United States

Research Center of the Ozarks, , MO, Everton, Missouri 65646, United States

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States

Cherry Hill Orthopedic Surgeons, Cherry Hill, New Jersey 08002, United States

Private Practice, Medford, New Jersey 08055, United States

Univeristy of Medicine and Dentistry of New Jersey, Stratford, New Jersey 08084, United States

Crescent Medical Assoc., Astoria, New York 11102, United States

Private Practice, Plainview, New York 11803, United States

State University of NY at Stonybrook, Stonybrook, New York 11794, United States

Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas, Charlotte, North Carolina 28207, United States

Albermarle Family Practice, Elizabeth City, North Carolina 27909, United States

New Hanover Medical Research, Wilmington, North Carolina 28412, United States

Odyssey Research Services, Bismark, North Dakota 58501, United States

Midwest Regional Research, Bellbrook, Ohio 45305, United States

COR Clinical Research, LLC, Oklahoma City, Oklahoma 73103, United States

Lyle, Austin Alexander PA, Tulsa, Oklahoma 74104, United States

Rouge Valley Clinical Research, Medford, Oregon 97504, United States

Southern Oregon Health & Wellness, Medford, Oregon 97504, United States

Keystone Clinical Solutions, Inc., Altoona, Pennsylvania 16602, United States

Arcuri Clinical Research, Philadelphia, Pennsylvania 19142, United States

Sidney Hillman Medical Center, Philadelphia, Pennsylvania 19103, United States

The Arthritis & Osteoporosis Center, Orangeburg, South Carolina 29118, United States

Alpha Clinical Research, Clarksville, Tennessee 37043, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Integrity Clinical Research, LLC (SMO), Milan, Tennessee 38358, United States

J. Lewis Research Foothill Family Clinic, Salt Lake City, Utah 84109, United States

J. Lewis Research Foothill Family Clinic South, Salt Lake City, Utah 84121, United States

LifeTree Clinical Reseach, Salt Lake City, Utah 84106, United States

Arthritis Clinic of No. Virginia, Arlington, Virginia 22205, United States

MedSource, Richmond, Virginia 23229, United States

Vantage Clinical Research Group, Lacey, Washington 98516, United States

Arthritis Northwest, Seattle, Washington 98166, United States

Clinical Trials Northwest, Yakima, Washington 98902, United States

Additional Information

Product Information

Starting date: January 2004
Last updated: August 27, 2012

Page last updated: August 20, 2015

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