NCT00312221

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Detailed description

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
DRUG	Buprenorphine	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
DRUG	oxycodone immediate-release	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Timeline

• Start date: 2004-04-01
• Primary completion: 2005-07-01
• Completion: 2005-08-01
• First posted: 2006-04-07
• Last updated: 2012-09-10
• Results posted: 2010-09-15

Locations

23 sites across 1 country: United States