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Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain

Chronic Pain Clinical Trial

Official title:
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-Naïve Patients With Chronic Low Back Pain

Clinical Trial Summary

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

Clinical Trial Description

Patients with low back pain who are sub-optimally responsive to their current analgesic treatment begin open-label treatment with oxymorphone extended release (ER). During the Open-Label Titration Period, patients will receive daily oxymorphone ER by mouth (PO) q12h. The investigator will initiate the Open-Label Titration Period using study drug at a dose of 5 mg PO q12h for 2 days; thereafter, patients will continue receiving 5 mg q12h or be titrated at increments of 5-10 mg q12h every 3-7 days until stabilization is achieved. The goal of the Open-Label Titration Period is to determine for each patient a fixed dose of study medication that is tolerated and achieves adequate analgesia. Stabilized patients will be randomiozed to either continue with current dose of oxymorphone ER or receive placebo for a total duration of 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00225797
Study type Interventional
Source Endo Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date July 2005
View Details
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