Celecoxib (Celebrex) in the Management of Acute Renal Colic
NCT00304317
ABOUT THIS STUDY
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- Ureteral calculus <= 10 mm in largest diameter
- Patient elects conservative management over immediate surgical intervention
- 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
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- Minneapolis, Minnesota
Descriptive Information | ||||
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Brief Title ICMJE | Celecoxib (Celebrex) in the Management of Acute Renal Colic | |||
Official Title ICMJE | Celecoxib in the Management of Acute Renal Colic | |||
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:
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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 than 10 mm in largest diameter on flat plain abdominal x-ray (KUB) or non-contrast computer tomography (CT) scan will be randomized in this trial. At the time of presentation with acute renal colic to the Emergency Department, the patient will be recruited for involvement. After informed consent, patients will be provided either 200 mg of Celebrex or a placebo equivalent. They will be instructed to follow the recommended dosing regimen for acute pain, taking two tablets in the emergency room (400 mg), followed by one tablet 12 hours later (200 mg), then one tablet twice a day for 10 days. Patients will be provided a prescription for Vicodin (1-2 tablets of 5/500 every 4-6 hours) to be taken as required for pain. Throughout the study, patients will be asked to strain urine for passage of calculus and note date and time of passage. Patients will also be asked to maintain a daily narcotic diary and complete a daily pain analog scale provided by our institution. Patients will be followed in the Urology Department's Stone Clinic with weekly imaging studies (KUB or CT scan) and renal function tests (serum creatinine) for 4 weeks. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Ureteral Calculi | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Enrollment ICMJE | 154 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00304317 | |||
Other Study ID Numbers ICMJE | 0405M60562 3485B | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Minnesota | |||
Study Sponsor ICMJE | University of Minnesota | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Minnesota | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |