Conditions: Osteoarthritis
Keywords: Osteoarthritis Opioid Transdermal
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 196
Healthy volunteers: no

Brief summary:
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

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

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 transdermally for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.

Protocol document: