Ureteral Calculi Clinical Trial
Official title:
Celecoxib in the Management of Acute Renal Colic
Verified date | January 2017 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in narcotic usage | at 48 hours | ||
Secondary | Increase in the percentage of spontaneous stone passage | 6 weeks | ||
Secondary | Shift in the size distribution of stones passed towards larger sizes | 6 weeks | ||
Secondary | Decrease in the time to spontaneous passage | 6 weeks |
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