Conditions: Osteoarthritis
Keywords: Chronic pain opioid transdermal osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 529
Healthy volunteers: no

Brief summary:
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.

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, 10 or 20 micrograms/hour (mcg/h) arm 2: Placebo to match BTDS 5, 10 or 20 mcg/h

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

Protocol document: