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

Completed · Phase 3 · Has a placebo group

Conditions studied: Back Pain

In brief

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) 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.

Key facts

Study ID

NCT00315445

Run by

Purdue Pharma LP

People needed

134

Starts

1997-12-01

Expected to finish

1998-05-01

Last updated by the study team

2012-09-03

Who can join

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

You may qualify if…

• clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, 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 </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

You may not qualify if…

• 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.

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Phoenix Center for Clinical Research — Phoenix, Arizona, United States
• Phoenix Orthopedic Center, Ltd. — Phoenix, Arizona, United States
• Gainesville Clinical Research Center — Gainesville, Florida, United States
• SeaView Research — Miami, Florida, United States
• Park Place Therapeutic Center — Plantation, Florida, United States
• Atlanta Research Center — Decatur, Georgia, United States
• The Center for Pharmaceutical Research, P.C. — Kansas City, Missouri, United States
• New Jersey Research Foundation — Linwood, New Jersey, United States
• North Carolina Clinical Research, Inc. — Raleigh, North Carolina, United States
• Research Across America — Dallas, Texas, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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