NCT00304317

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

March 16, 2006

Last Update Submit

January 23, 2017

Conditions

Ureteral Calculi

Keywords

calculiureteral calculiureter

Outcome Measures

Primary Outcomes (1)

  • Decrease in narcotic usage

    at 48 hours

Secondary Outcomes (3)

  • Increase in the percentage of spontaneous stone passage

    6 weeks

  • Shift in the size distribution of stones passed towards larger sizes

    6 weeks

  • Decrease in the time to spontaneous passage

    6 weeks

Study Arms (2)

I

EXPERIMENTAL

Celecoxib

Drug: celecoxib

II

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

celecoxibDRUG

Take two capsules (400 mg) by mouth immediately, then take one capsule (200 mg) by mouth every 12 hours until gone.

Also known as: Celebrex
I
PlaceboOTHER

Take two capsules by mouth immediately, then take one capsule by mouth every 12 hours until gone.

II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ureteral calculus \<= 10 mm in largest diameter
  • Patient elects conservative management over immediate surgical intervention

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ureteral CalculiCalculi

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Manoj Monga, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(1)