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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.