Conditions: Low Back Pain
Keywords: Chronic pain opioid transdermal Moderate to severe chronic low back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 539
Healthy volunteers: no

Brief summary:
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Arms:
arm 1: Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7 days

Interventions: intervention 1: Buprenorphine transdermal system intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days intervention 2: transdermal system (placebo) worn for 7 days

Protocol document: