NCT00315835

Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.

A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (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 of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) 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. 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

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal delivery system

Timeline

• Start date: 1996-10-01
• Completion: 1997-11-01
• First posted: 2006-04-19
• Last updated: 2006-04-19

Locations

1 site across 1 country: United States