Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 418
Healthy volunteers: no

Brief summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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 arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Interventions: intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: oxycodone immediate-release
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 intervention 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Protocol document: