Celecoxib (Celebrex) in the Management of Acute Renal Colic - Full Text View

Sponsors and Collaborators:	University of Minnesota Pfizer
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00304317

Purpose

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	Intervention	Phase
Ureteral Calculi	Drug: celecoxib Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Celecoxib in the Management of Acute Renal Colic

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

Decrease in narcotic usage [ Time Frame: at 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase in the percentage of spontaneous stone passage [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Shift in the size distribution of stones passed towards larger sizes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Decrease in the time to spontaneous passage [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	57
Study Start Date:	March 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Celecoxib	Drug: celecoxib Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
II: Placebo Comparator Placebo	Other: Placebo Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304317

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Pfizer

Investigators

Principal Investigator:

Manoj Monga, MD

University of Minnesota

More Information

No publications provided

Responsible Party:	University of Minnesota ( Manoj Monga, MD )
Study ID Numbers:	0405M60562, 3485B
Study First Received:	March 16, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00304317 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

calculi
ureteral calculi
ureter

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Urinary Calculi
Celecoxib
Urolithiasis
Colic
Cyclooxygenase Inhibitors
Ureteral Calculi
Ureteral Diseases

Calculi
Ureterolithiasis
Urologic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Urinary Calculi
Celecoxib
Molecular Mechanisms of Pharmacological Action
Urolithiasis
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Ureteral Calculi
Ureteral Diseases
Enzyme Inhibitors
Calculi

Pharmacologic Actions
Ureterolithiasis
Urologic Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 24, 2009