Celecoxib (Celebrex) in the Management of Acute Renal Colic

• Status: Withdrawn
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Pfizer
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Ureteral calculus <= 10 mm in largest diameter

• Patient elects conservative management over immediate surgical intervention

Exclusion Criteria:

• Solitary kidney

• Renal insufficiency (creatinine [CR] > 1.8)

• Urinary infection (fever > 101 degrees Fahrenheit, positive urine culture, many bacteria on urinalysis)

• Allergic-type reactions to sulfonamides

• Patients with known hypersensitivity to celecoxib

• Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)

• Prior history of gastrointestinal (GI) bleed or active gastric ulcer disease

• Pregnancy/nursing

• Moderate-severe hepatic dysfunction (Child-Pugh Classification B or C)

• Concomitant use of drugs that inhibit P450 2C9, drugs metabolized by P450 2D6, ACE inhibitors, furosemide, warfarin (and other anticoagulants, not including low-dose aspirin), fluconazole, or lithium

• Women of child-bearing age unwilling to use effective contraception for the duration of the trial.

• Significant or unstable cardiovascular disease defined as:

• myocardial infarction or stroke less than 3 months prior to the study randomization

• planned revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass surgery [CABG]) at the time of study screening

• angina at rest or uncontrolled angina

• hospitalization or emergency department visits for cardiac-related illness less than 3 months prior to randomization

• uncontrolled hypertension (defined as systolic blood pressure [BP] > 140 mmHg and/or diastolic BP > 90 mmHg at the baseline visit)

• evidence of cardiac electrophysiologic instability including history of uncontrolled complex ventricular arrhythmia, uncontrolled atrial fibrillation or flutter, or uncontrolled supraventricular tachycardias with a ventricular response heart rate of > 100 beats per minute (BPM) at rest. (Subjects whose cardiac electrophysiologic instability is controlled with a pacemaker or implantable cardioverter defibrillator (ICD) are eligible.)

• symptoms, signs or treatment for congestive heart failure (CHF) or known left ventricular dysfunction with ejection fraction < 40%

• undergone coronary bypass surgery or any major surgery (cardiac or noncardiac) or trauma within the past 3 months