Conditions: Osteoarthritis
Keywords: osteoarthritis opioid transdermal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

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 patches 10 or 20 mcg/h arm 2: Placebo to match buprenorphine transdermal patch 10 or 20

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

Protocol document: