Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Collaborator: Napp Pharmaceuticals Limited
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.

• Good, very good or excellent pain control on current opioid therapy.

• Willing and able to use a telephone interactive voice response service.

Exclusion Criteria:

• Currently receiving daily morphine or oxycodone monotherapy.

• Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.