Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Status:
Terminated
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of
the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the
buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis
pain currently treated with oral opioids. The double-blind treatment intervention duration is
12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen)
will be provided to all subjects in addition to study drug.
This study was terminated early due to administrative reasons with only 20% of the planned
sample size; therefore, the primary objective was changed to focus on the safety evaluation.