NCT00314652

Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (planned)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal delivery system

Timeline

• Start date: 1999-06-01
• Completion: 1999-10-01
• First posted: 2006-04-14
• Last updated: 2006-05-03

Locations

22 sites across 1 country: United States