A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Virgina Beach, Virginia 23454, United States