Conditions: Osteoarthritis
Keywords: Osteoarthritis Opioid Transdermal
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 290
Healthy volunteers: no

Brief summary:
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Arms:
arm 1: Buprenorphine transdermal patch

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear intervention 3: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Protocol document: