Celecoxib (Celebrex) in the Management of Acute Renal Colic

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Ureteral Calculi

In brief

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

Key facts

Study ID

NCT00304317

Run by

University of Minnesota

People needed

0

Starts

2006-03-01

Expected to finish

2008-08-01

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ureteral calculus <= 10 mm in largest diameter
• Patient elects conservative management over immediate surgical intervention

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.