NCT01151098

Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Nonmalignant Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear

Timeline

• Start date: 2001-04-01
• Primary completion: 2002-02-01
• Completion: 2002-02-01
• First posted: 2010-06-25
• Last updated: 2012-09-10
• Results posted: 2010-09-23

Locations

19 sites across 1 country: United States