Celecoxib (Celebrex) in the Management of Acute Renal Colic

January 23, 2017 updated by: University of Minnesota

Celecoxib in the Management of Acute Renal Colic

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in narcotic usage
Time Frame: at 48 hours
at 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in the percentage of spontaneous stone passage
Time Frame: 6 weeks
6 weeks
Shift in the size distribution of stones passed towards larger sizes
Time Frame: 6 weeks
6 weeks
Decrease in the time to spontaneous passage
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Pfizer

Investigators

  • Principal Investigator: Manoj Monga, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405M60562
  • 3485B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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