Conditions: Chronic Non-malignant Pain
Keywords: Chronic pain opioid transdermal Butrans™ [BTDS]
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 267
Healthy volunteers: no

Brief summary:
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 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 arm 2: Placebo to match buprenorphine transdermal patch

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

Protocol document: