Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.