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Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

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); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Purdue Pharma LP

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

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

Primary outcome: The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.

Secondary outcome: Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site

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: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.

- an average pain due to osteoarthritis of moderate, moderately-severe, or severe for

the 14 days prior to enrollment. Exclusion Criteria:

- ingest opioid analgesics on a daily basis.

- ingest >2500 milligrams (mg) acetaminophen on a daily basis.

- require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of

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

Locations and Contacts

Vista Medical Research, Mesa, Arizona 85206, United States

Arizona Research Center, Phoenix, Arizona 85012, United States

Arizona Research Center, Phoenix, Arizona 85023, United States

Radiant Research, Phoenix, Arizona 85013, United States

ACRC/Arizona Clinical Research, Tucson, Arizona 85715, United States

Advance Pain Medicine, Bakersfield, California 93311, United States

Eastgate Medical Center, Cypress, California 90623, United States

University Osteoporosis Ctr, Loma Linda, California 92354, United States

San Diego Arthritis & Osteoporosis Medical Clinic, San Diego, California 92108, United States

Scripps Clinic Rancho Bernard, San Diego, California 92128, United States

CNS Clinical Trials, Inc, San Francisco, California 94121, United States

Mountain View Clinical Research, Denver, Colorado 80209, United States

Integrative Treatment Centers/Rocky Mtn Clin Res, Westminster, Colorado 80021, United States

Rocky Mountain Center for Clinical Research, Wheat Ridge, Colorado 80033, United States

Stamford Therapeutic Consortium, Bridgeport, Connecticut 66060, United States

Medical Specialists of the Palm Beaches, Atlantis, Florida 33462, United States

University Clinical Research Deland, Deland, Florida 32720, United States

Drug Study Institute, Jupiter, Florida 33458, United States

Coastal Medical Research, Orange City, Florida 32763, United States

Coastal Medical Research, Port Orange, Florida 32127, United States

Palm Beach Research Center, W. Palm Beach, Florida 33409, United States

Gold Coast Research, Weston, Florida 33331, United States

Non-Surgical Orthopedic & Spine Center, Marietta, Georgia 30060, United States

Columbus Internal Medical Associates, Columbus, Indiana 47201, United States

MediSphere Medical Research Ctr., Evansville, Indiana 47714, United States

Primary Care Research, Murray, Kentucky 42071, United States

Professional Clinical Research, Cadillac, Michigan 49601, United States

Sound Medical At West Front Primary Care, Traverse City, Michigan 49684, United States

Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care, New York, New York 10003, United States

All-Trials Clinical Research, LLC, Winston-Salem, North Carolina 27103, United States

Keystone Clinical, Altoona, Pennsylvania 16602, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

University Orthopedics Center, State College, Pennsylvania 16801, United States

Clinical Research Center of Reading, LLP, West Reading, Pennsylvania 19611, United States

Low Country Rheumatology, Charleston, South Carolina 29406, United States

Brown Clinic, Watertown, South Dakota 57201, United States

Private Practice, Dallas, Texas 75251, United States

Team Research of Central Texas, Harker Heights, Texas 76548, United States

Radiant Research San Antonio Northeast, San Antonio, Texas 78217, United States

ACCU Clinical Research Trials, Inc, Seguin, Texas 78155, United States

Wasatch Clinical Research, Salt Lake City, Utah 84107, United States

Advance Pain Management & Rehab, Virgina Beach, Virginia 23454, United States

Evergreen Clinical Research Associates, Edmonds, Washington 98026, United States

Internal Medicine Northwest, Tacoma, Washington 98405, United States

Additional Information

Product Information

Starting date: April 2003
Last updated: August 27, 2012

Page last updated: August 20, 2015

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