NCT00531427

Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 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 pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization 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

• Chronic Pain
• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Buprenorphine	transdermal system 10 and 20 applied for 7-day wear
DRUG	Placebo	transdermal system (placebo) applied for 7-day wear

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-04-01
• Completion: 2009-11-01
• First posted: 2007-09-18
• Last updated: 2012-09-10
• Results posted: 2010-09-21

Locations

87 sites across 1 country: United States