NCT00490919

Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain

Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal system	Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
DRUG	Placebo	transdermal system (placebo) worn for 7 days

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2007-06-25
• Last updated: 2012-09-10
• Results posted: 2010-09-09

Locations

86 sites across 1 country: United States