Status:
WITHDRAWN
Celecoxib (Celebrex) in the Management of Acute Renal Colic
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Pfizer
Conditions:
Ureteral Calculi
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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 th...
Eligibility Criteria
Inclusion
- Ureteral calculus \<= 10 mm in largest diameter
- Patient elects conservative management over immediate surgical intervention
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00304317
Start Date
March 1 2006
End Date
August 1 2008
Last Update
January 24 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455