Celecoxib (Celebrex) in the Management of Acute Renal Colic

NCT00304317

Last updated date
Study Location
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ureteral Calculi
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ureteral calculus <= 10 mm in largest diameter

- Patient elects conservative management over immediate surgical intervention

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Ureteral CalculiCelecoxib (Celebrex) in the Management of Acute Renal Colic
NCT00304317
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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:

  • 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
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
  • Drug: celecoxib
    Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
    Other Name: Celebrex
  • Other: Placebo
    Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
Study Arms  ICMJE
  • Experimental: I
    Celecoxib
    Intervention: Drug: celecoxib
  • Placebo Comparator: II
    Placebo
    Intervention: Other: Placebo
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
 (submitted: January 23, 2017)
0
Original Enrollment  ICMJE
 (submitted: March 16, 2006)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Manoj Monga, MDUniversity of Minnesota
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