Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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-Experienced Patients With Chronic Low Back Pain|
- Change in pain intensity from baseline (pre-randomization) to last assessment.
- - Time to early discontinuation due to lack of efficacy
- - Patient's Global Assessment of Pain Medication
- - Physician's Global Assessment of Pain Medication
- - Pain Quality Assessment Scale
- - Safety as measured by AEs
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||August 2005|
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.
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