The Safety and Efficacy of the Buprenorphine Transdermal System in Subjects With Chronic Back Pain.

Condition(s) targeted: Back Pain

Intervention: Buprenorphine transdermal delivery system (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Purdue Pharma LP

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Official title: A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

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

Primary outcome: Pain on the average and pain right now scores on days 1, 7, 21, 30, 45, 60, 75, 84, and, if applicable, at early termination.

Secondary outcome:

Discontinuation due to lack of efficacy

Medical Outcomes Study health survey

therapeutic response

patient preference

daily patient diary for average pain

time to stable pain management

number of post-titration dose adjustments

patient satisfaction.

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:

- clinical evidence of stable, chronic (>2 months) back pain related to intervertebral

disc disease, nerve root entrapment, spondylolithiasis, and osteoarthritis or other, similar nonmalignant conditions.

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

drug considered at a therapeutic and/or tolerated dose or, subjects currently taking Exclusion Criteria:

- receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or

receiving more than 12 tablets per day of short-acting opioid-containing products.

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

postoperative 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

Phoenix Orthopedic Center, Ltd., Phoenix, Arizona 85023, United States

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

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

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

SeaView Research, Miami, Florida 33134, United States

Atlanta Research Center, Decatur, Georgia 30033, United States

The Center for Pharmaceutical Research, P.C., Kansas City, Missouri 64114, United States

New Jersey Research Foundation, Linwood, New Jersey 08221, United States

North Carolina Clinical Research, Inc., Raleigh, North Carolina 27607, United States

Research Across America, Dallas, Texas 75234, United States

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

Starting date: December 1997
Ending date: May 1998
Last updated: April 29, 2006