NCT00226421

Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain

An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Experienced Patients With Chronic Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.

Detailed description

Patients with chronic low back pain on stable opioid treatment will be converted to oxymorphone extended release (ER)and enter an open-label treatment phase.During the Open-Label Titration Period (up to 28 days), patients will receive daily oxymorphone ER PO q12h. Patients stabilized on a dose that provides adequate pain relief will be randomized to either continue on the stabilized dose of oxymorphone ER or receive placebo in a double-blind fashion for a total duration of 12 weeks.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Oxymorphone Extended Release

Timeline

• Start date: 2004-10-01
• Completion: 2005-08-01
• First posted: 2005-09-27
• Last updated: 2024-01-02

Locations

31 sites across 1 country: United States