NCT00304317

Celecoxib (Celebrex) in the Management of Acute Renal Colic

Celecoxib in the Management of Acute Renal Colic

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * reduce pain medication usage * improve the percentage of spontaneous stone passage * decrease the time to spontaneous passage, and * shift the size distribution of stones passed towards larger sizes

Detailed description

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.

Conditions

• Ureteral Calculi

Interventions

Type	Name	Description
DRUG	celecoxib	Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
OTHER	Placebo	Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-03-17
• Last updated: 2017-01-24

Locations

1 site across 1 country: United States