Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Status:
Completed
Trial end date:
2009-11-01
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 pain due to osteoarthritis (OA) of the knee. The
double-blind treatment intervention duration is 12 weeks, during which time supplemental
analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and
acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to
all subjects in addition to study drug.