At a glance
ClinicalIndex Comparison Record- ✓At least 2 months history of nonmalignant chronic 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 telephone interactive voice response service
- ✕Currently receiving daily morphine or oxycodone monotherapy
- ✕Scheduled for surgery of the disease site (e.g., major joint replacement) or any other major surgery within the study period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
In Brief
A Phase 3 clinical trial evaluating Buprenorphine transdermal patch and Placebo to match BTDS for Chronic Non-malignant Pain. Completed, enrolled 267 participants across 42 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Placebo to match buprenorphine transdermal patch applied for 7-day wear.