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

Completed · Phase 3

Conditions studied: Back Pain

In brief

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.

Key facts

Study ID

NCT00315874

Run by

Purdue Pharma LP

People needed

225

Starts

1997-04-01

Expected to finish

1998-01-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
• taking >/=3 opioid doses per day with or without acceptable pain control.

You may not qualify if…

• 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.

Where it is running

• Hawthorne & York, Intl, Ltd — Phoenix, Arizona, United States
• Arizona Research & Education — Phoenix, Arizona, United States
• Gainesville Clinical Research Center — Gainesville, Florida, United States
• Park Place Therapeutic Center — Plantation, Florida, United States
• Atlanta Research Center — Atlanta, Georgia, United States
• Rheumatology Associates, Inc. — Indianapolis, Indiana, United States
• Westside Family Medical Center — Kalamazoo, Michigan, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• The New York Hospital Cornell Medical Center — New York, New York, United States
• NC Clinical Research, Inc. — Raleigh, North Carolina, United States
• Pain Control Ctr Bowman Gray School of Med — Winston-Salem, North Carolina, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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