Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain Opioid Transdermal
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 354
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). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

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 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: