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Sponsors and Collaborators: |
University of Minnesota Pfizer |
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Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00304317 |
The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2 (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone will:
Condition | Intervention | Phase |
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Ureteral Calculi |
Drug: celecoxib Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Celecoxib in the Management of Acute Renal Colic |
Enrollment: | 57 |
Study Start Date: | March 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
Celecoxib
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Drug: celecoxib
Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
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II: Placebo Comparator
Placebo
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Other: Placebo
Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
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The study will be conducted as a prospective, randomized, double-blind controlled clinical trial. One-hundred and fifty-four patients with symptoms of acute renal colic and a ureteral calculus less than 10 mm in largest diameter on flat plain abdominal x-ray (KUB) or non-contrast computer tomography (CT) scan will be randomized in this trial. At the time of presentation with acute renal colic to the Emergency Department, the patient will be recruited for involvement. After informed consent, patients will be provided either 200 mg of Celebrex or a placebo equivalent. They will be instructed to follow the recommended dosing regimen for acute pain, taking two tablets in the emergency room (400 mg), followed by one tablet 12 hours later (200 mg), then one tablet twice a day for 10 days. Patients will be provided a prescription for Vicodin (1-2 tablets of 5/500 every 4-6 hours) to be taken as required for pain. Throughout the study, patients will be asked to strain urine for passage of calculus and note date and time of passage. Patients will also be asked to maintain a daily narcotic diary and complete a daily pain analog scale provided by our institution. Patients will be followed in the Urology Department's Stone Clinic with weekly imaging studies (KUB or CT scan) and renal function tests (serum creatinine) for 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Significant or unstable cardiovascular disease defined as:
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Manoj Monga, MD | University of Minnesota |
Responsible Party: | University of Minnesota ( Manoj Monga, MD ) |
Study ID Numbers: | 0405M60562, 3485B |
Study First Received: | March 16, 2006 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00304317 History of Changes |
Health Authority: | United States: Institutional Review Board |
calculi ureteral calculi ureter |
Pathological Conditions, Anatomical Anti-Inflammatory Agents Urinary Calculi Celecoxib Urolithiasis Colic Cyclooxygenase Inhibitors Ureteral Calculi Ureteral Diseases |
Calculi Ureterolithiasis Urologic Diseases Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Pathological Conditions, Anatomical Urinary Calculi Celecoxib Molecular Mechanisms of Pharmacological Action Urolithiasis Physiological Effects of Drugs Cyclooxygenase Inhibitors Ureteral Calculi Ureteral Diseases Enzyme Inhibitors Calculi |
Pharmacologic Actions Ureterolithiasis Urologic Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |