Celecoxib (Celebrex) in the Management of Acute Renal Colic

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, manybacteria on urinalysis)

• Allergic-type reactions to sulfonamides

• Patients with known hypersensitivity to celecoxib

• Patients who have experienced asthma, urticaria, or allergic-type reactions aftertaking 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, ACEinhibitors, furosemide, warfarin (and other anticoagulants, not including low-doseaspirin), fluconazole, or lithium

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

• Significant or unstable cardiovascular disease defined as:

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

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

• angina at rest or uncontrolled angina

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

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

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

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

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