Conditions: Back Pain
Keywords: chronic back pain opioid transdermal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for 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: Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20 arm 2: 5 mg oxycodone/325 mg acetaminophen tablets arm 3: Buprenorphine transdermal patch 5, 10, or 20 mcg/hour

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo oxycodone/acetaminophen tablets intervention 3: OXY/APAP intervention 4: Placebo transdermal patch (TDS)
Intervention descriptions: intervention 1: Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 3: 5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 4: Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear

Protocol document: