The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis

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

Primary outcome: Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.

Secondary outcome:

Brief Pain Inventory

dropouts due to lack of efficacy

MOS health survey

VAS pain intensity

therapeutic response

patient preference

daily patient diary

and number of oxycodone/acetaminophen or placebo tablets taken

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

Criteria:

Inclusion Criteria:

- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory

drug considered at a therapeutic and/or tolerated dose or currently taking - taking >/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

- receiving opioids at an average daily dose of greater than 60 mg of oral morphine

equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.

- scheduled to have surgery (including dental) involving the use of post- or

preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Rheumatology Associates of North Alabama, Huntsville, Alabama 35801, United States

Arizona Research and Education, Phoenix, Arizona 85012, United States

Phoenix Center for Clinical Research, Phoenix, Arizona 85015, United States

Western Integrated Pain Treatment Centers, Westminster, Colorado 80030, United States

Gainesville Clinical Research Center, Gainesville, Florida 32605, United States

Park Place Therapeutic Center, Plantation, Florida 33324, United States

MediSphere Medical Research Center, L.L.C., Evansville, Indiana 47714, United States

Stratton VA Medical Center, Albany, New York 12208, United States

Metroplex Clinical Research Center, Dallas, Texas 75235, United States

Arthritis Diagnostic and Treatment Center, San Antonio, Texas 78240, United States

Starting date: November 1996
Ending date: December 1999
Last updated: April 29, 2006