Conditions: Osteoarthritis
Keywords: Chronic pain osteoarthritis transdermal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 188
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Protocol document: