Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System in Subjects With Osteoarthritis

Condition(s) targeted: Osteoarthritis

Intervention: Buprenorphine transdermal delivery system (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Purdue Pharma LP

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system 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.

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Completion of the 14-day double-blind phase.

Secondary outcome:

Proportion of days a subject had successful analgesia

rate of premature discontinuation

mean daily average pain over last 24 hours score

WOMAC Osteoarthritis Index score

Medical Outcome Study Sleep Scale score

and treatment satisfaction survey

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/

acetaminophen for their OA pain.

Exclusion Criteria:

- currently have condition requiring a stable regimen of 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.

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

Lovelace Scientific Resources, Beverly Hills, California 90211, United States

Southbay Pharma Research, Buena Park, California 90620, United States

Kaiser Permanente, Escondido, California 92025, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Univ. of Southern California, Santa Monica, California 90404, United States

Community Medical Providers, Clovis, California 93611, United States

Arthritis Center of CT, Waterbury, Connecticut 06708, United States

Lifespan Research Foundation, Inc., Miami, Florida 33186, United States

Neuro Science and Spine Assoc., Naples, Florida 34102, United States

Miami Beach Anesthesiology Associates, Miami Beach, Florida 33140, 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

PCM Medical Services, Lansing, Michigan 48917, United States

Westside Family Medical Center, Kalamazoo, Michigan 49009, 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

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

CEDRA Clinical Research,, Austin, Texas 78759, United States

Monroe Medical Foundation, Monroe, Wisconsin 53566, United States

Starting date: June 2003
Ending date: July 2004
Last updated: November 13, 2006