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

Completed · Phase 3

Conditions studied: Chronic Low Back Pain

In brief

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00315887

Run by

Purdue Pharma LP

People needed

250

Starts

1999-04-01

Expected to finish

1999-10-01

Last updated by the study team

2006-05-03

Who can join

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

You may qualify if…

• clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
• back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

You may not qualify if…

• receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
• scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Arthritis Center of Connecticut — Waterbury, Connecticut, United States
• University Clinical Research — DeLand, Florida, United States
• Gainesville Clinical Research Center — Gainesville, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Sarasota Arthritis Center — Sarasota, Florida, United States
• Coastal Medical Research — South Daytona Beach, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Private Practice — Weston, Florida, United States
• Pain Management & Rehabilitation — Terre Haute, Indiana, United States
• Mid-America Rheumatology Consultants — Overland Park, Kansas, United States
• Riverhills Healthcare — Crestview Hills, Kentucky, United States
• Arthritis & Osteoporosis Treatment & Research Center — Jackson, Mississippi, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• PrecisionMed, Inc. — Las Vegas, Nevada, United States
• Cornerstone Research Care — High Point, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• Center for Clinical Research — Austin, Texas, United States
• The Arthritis Clinic of Northern Virginia — Arlington, Virginia, United States
• Evergreen Clinical Research — Edmonds, Washington, United States
• Private Practice — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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