Celecoxib (Celebrex) in the Management of Acute Renal Colic

This study has been terminated.
(PI is no longer at the University of Minnesota)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00304317
First received: March 16, 2006
Last updated: May 20, 2014
Last verified: May 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Celecoxib in the Management of Acute Renal Colic

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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
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 Name: Celebrex
Placebo Comparator: II
Placebo
Other: Placebo
Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.
Other Name: placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Clinical and Translational Science Institute
Pfizer
Investigators
Principal Investigator: Manoj Monga, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00304317     History of Changes
Other Study ID Numbers: 0405M60562, 3485B
Study First Received: March 16, 2006
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
calculi
ureteral calculi
ureter

Additional relevant MeSH terms:
Calculi
Renal Colic
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014