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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00226395 |
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
Condition | Intervention | Phase |
---|---|---|
Acute Pain |
Drug: Oxymorphone immediate release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery |
Estimated Enrollment: | 320 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | August 2005 |
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Montgomery Women's Health Associates | |
Montgomery, Alabama, United States, 36113 | |
The Medical Center, Dept. Clinical research | |
Birmingham, Alabama, United States, 35205 | |
Brookwood Medical Center | |
Birmingham, Alabama, United States, 35205 | |
United States, Arizona | |
Arrowhead Community Hospital | |
Phoenix, Arizona, United States, 85023 | |
Paradise Valley Hospital | |
Phoenix, Arizona, United States, 85023 | |
John C Lincoln Hospital | |
Phoenix, Arizona, United States, 85023 | |
United States, California | |
Saddleback Memorial Medical Center | |
Laguna Hills, California, United States, 92653 | |
Huntington Memorial Hospital | |
Pasadena, California, United States, 91109 | |
Glendale Adventist Medical Center | |
Glendale, California, United States, 91206 | |
United States, Florida | |
Palm West Hospital | |
Palm Springs, Florida, United States, 33461 | |
Sacred Heart Hospital | |
Pensacola, Florida, United States, 32514 | |
United States, North Carolina | |
Forsyth Medical Center | |
Winston-Salem, North Carolina, United States, 27103 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Medical Park Hospital | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Pennsylvania | |
Univ. Pittsburgh Medical center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Univ. Pittsburgh Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Memorial Hermann Memorial City Hospital | |
Houston, Texas, United States, 77024 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
McKay-Dee Hospital | |
Salt Lake City, Utah, United States, 84124 | |
LDS Hospital | |
Salt Lake City, Utah, United States, 84124 | |
Cottonwood Hospital | |
Salt Lake City, Utah, United States, 84124 |
Study ID Numbers: | EN3203-009 |
Study First Received: | September 23, 2005 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00226395 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oxymorphone acute pain abdominal surgery opioids |
Adjuvants, Immunologic Anesthetics Central Nervous System Depressants Narcotics Pain |
Peripheral Nervous System Agents Analgesics Analgesics, Opioid 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 Oxymorphone |