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Celecoxib (Celebrex) in the Management of Acute Renal Colic

Primary Purpose

Ureteral Calculi

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Calculi focused on measuring calculi, ureteral calculi, ureter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

I

II

Arm Description

Celecoxib

Placebo

Outcomes

Primary Outcome Measures

Decrease in narcotic usage

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2006
Last Updated
January 23, 2017
Sponsor
University of Minnesota
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00304317
Brief Title
Celecoxib (Celebrex) in the Management of Acute Renal Colic
Official Title
Celecoxib in the Management of Acute Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI is no longer at the University of Minnesota
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi
Keywords
calculi, ureteral calculi, ureter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Celecoxib
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
Primary Outcome Measure Information:
Title
Decrease in narcotic usage
Time Frame
at 48 hours
Secondary Outcome Measure Information:
Title
Increase in the percentage of spontaneous stone passage
Time Frame
6 weeks
Title
Shift in the size distribution of stones passed towards larger sizes
Time Frame
6 weeks
Title
Decrease in the time to spontaneous passage
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Celecoxib (Celebrex) in the Management of Acute Renal Colic

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