Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain opioid transdermal Butrans
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 660
Healthy volunteers: no

Brief summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) 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 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 HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Protocol document: