Conditions: Chronic Nonmalignant Pain
Keywords: Chronic nonmalignant pain Opioid Transdermal Butrans (BTDS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 189
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Detailed description:
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Arms:
arm 1: Buprenorphine transdermal patch

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

Protocol document: