Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00490919

Run by

Purdue Pharma LP

People needed

539

Starts

2007-06-01

Expected to finish

2008-10-01

Last updated by the study team

2012-09-10

Who can join

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

You may qualify if…

• Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
• Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
• Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

You may not qualify if…

• Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
• Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
• Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
• Other protocol-specific inclusion/exclusion criteria may apply.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Radiant Research; Phoenix Southeast — Chandler, Arizona, United States
• Arizona Research Center Inc. — Phoenix, Arizona, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Anaheim, California, United States
• Lovelace Scientific Resources, Inc. — Beverly Hills, California, United States
• Research Facility — Carmichael, California, United States
• Advance Care Medical Group — City of Industry, California, United States
• Research Facility — Downey, California, United States
• Research Facility — Foothill Ranch, California, United States
• Research Facility — Sacramento, California, United States
• Research Facility — San Luis Obispo, California, United States
• Research Facility — Littleton, Colorado, United States
• Research Facility — Stamford, Connecticut, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Research Facility — Clearwater, Florida, United States
• University Clinical Research — DeLand, Florida, United States
• Arthritis Associates of S. FL — Delray Beach, Florida, United States
• Research Facility — Fort Myers, Florida, United States
• Century Clinical Research, Inc. — Holly Hill, Florida, United States
• Research Facility — Jupiter, Florida, United States
• Research Facility — Largo, Florida, United States
• Research Facility — Merritt Island, Florida, United States
• Research Facility — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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