The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low 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 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 chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Official title: Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days Vs. 5 Mg Oxycodone/325 Mg Acetaminophen Tablets q6h Prn Vs. Placebo in Patients With Chronic Low Back Pain

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 if applicable, 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.

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

Hawthorne & York, Intl, Ltd, Phoenix, Arizona 85008, United States

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

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

Atlanta Research Center, Atlanta, Georgia 30033, United States

Rheumatology Associates, Inc., Indianapolis, Indiana 46260, United States

Westside Family Medical Center, Kalamazoo, Michigan 49009, United States

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

The New York Hospital Cornell Medical Center, New York, New York 10021, United States

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

Pain Control Ctr Bowman Gray School of Med, Winston-Salem, North Carolina 27103, United States

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

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