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| Sponsor: | Endo Pharmaceuticals |
|---|---|
| Information provided by: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00226421 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: Oxymorphone Extended Release |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 120 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 31 Study Locations
More Information
| Responsible Party: | Sr. Director Clinical R&D |
| ClinicalTrials.gov Identifier: | NCT00226421 History of Changes |
| Other Study ID Numbers: | EN3202-032 |
| Study First Received: | September 23, 2005 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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opioid oxymorphone chronic pain randomized, double-blind trial low back pain |
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Low Back Pain Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Oxymorphone Analgesics, Opioid Adjuvants, Anesthesia |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics |