Celecoxib (Celebrex) in the Management of Acute Renal Colic
Ureteral Calculi
About this trial
This is an interventional treatment trial for Ureteral Calculi focused on measuring calculi, ureteral calculi, ureter
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
I
II
Celecoxib
Placebo