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Sponsored by: |
Javelin Pharmaceuticals |
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Information provided by: | Javelin Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00448110 |
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery. The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
Condition | Intervention | Phase |
---|---|---|
Pain, Postoperative |
Drug: Intravenous Diclofenac (DIC075V) Drug: Parenteral Ketorolac |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional Inclusion/Exclusion Criteria May Apply
United States, Alabama | |
Alabama Clinical Therapeutics | |
Birmingham, Alabama, United States, 35235 | |
Helen Keller Hospital | |
Sheffield, Alabama, United States, 35660 | |
Drug Research and Analysis Corp. | |
Montgomery, Alabama, United States, 36106 | |
Eliza Coffee Memorial Hospital | |
Florence, Alabama, United States, 35630 | |
United States, Arkansas | |
Teton Research / Parkview Surgical | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Glendale Adventist Medical Center | |
Glendale, California, United States, 91206 | |
Saddleback Memorial Medical Center | |
Laguna Hills, California, United States, 92653 | |
Clinical Management Services | |
Arcadia, California, United States, 91107 | |
United States, Florida | |
Visions Clinical Research | |
Boynton Beach, Florida, United States, 33437 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, North Dakota | |
Clinical Research Services | |
Bismarck, North Dakota, United States, 58501 | |
United States, Texas | |
Clinical Research Center | |
Austin, Texas, United States, 78705 | |
Clinical Research Center | |
San Marcos, Texas, United States, 78666 | |
The Woman's Hospital of Texas | |
Houston, Texas, United States, 77054 | |
Memorial Hermann Healthcare System - Memorial City Hospital | |
Houston, Texas, United States, 77024 | |
United States, Utah | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 |
Study ID Numbers: | DFC-004 |
Study First Received: | March 13, 2007 |
Last Updated: | July 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00448110 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Postoperative Complications Ketorolac Diclofenac |
Pain Ketorolac Tromethamine Pain, Postoperative |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |