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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00226421 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males or females 18 years of age or older
– In good health as determined by the Investigator on the basis of medical history and physical examination.
Exclusion Criteria:
Study ID Numbers: | EN3202-032 |
Study First Received: | September 23, 2005 |
Last Updated: | December 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00226421 |
Health Authority: | United States: Food and Drug Administration |
opioid oxymorphone chronic pain randomized, double-blind trial low back pain |
Low Back Pain Pain Back Pain Oxymorphone |
Adjuvants, Anesthesia Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |