Celecoxib (Celebrex) in the Management of Acute Renal Colic

Sponsor

University of Minnesota (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00304317

Collaborator

Pfizer (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Drug: celecoxib Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Celecoxib in the Management of Acute Renal Colic

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Celecoxib	Drug: celecoxib Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone. Other Names: Celebrex
Placebo Comparator: II Placebo	Other: Placebo Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

Arm

Intervention/Treatment

Experimental: I

Celecoxib

Drug: celecoxib

Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.

Other Names:

Celebrex

Placebo Comparator: II

Placebo

Other: Placebo

Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

Outcome Measures

Primary Outcome Measures

Decrease in narcotic usage [at 48 hours]

Secondary Outcome Measures

Increase in the percentage of spontaneous stone passage [6 weeks]
Shift in the size distribution of stones passed towards larger sizes [6 weeks]
Decrease in the time to spontaneous passage [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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