Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain
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.
|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-Naïve 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
- Safety as measured by AEs
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||July 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225797
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