Celecoxib (Celebrex) in the Management of Acute Renal Colic

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

• Drug: celecoxib
  Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
  Other Name: Celebrex
• Other: Placebo
  Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

• Experimental: I
  Celecoxib
  Intervention: Drug: celecoxib
• Placebo Comparator: II
  Placebo
  Intervention: Other: Placebo

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