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Ondansetron for Colonoscopy Prep

Phase 4
Waitlist Available
Led By Thomas Wallach, MD
Research Sponsored by State University of New York - Downstate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after dose
Awards & highlights

Study Summary

This trial is testing whether ondansetron can improve bowel prep outcomes and patient experience for children undergoing colonoscopies.

Who is the study for?
This trial is for children and teenagers aged between 2 and 20 who need a colonoscopy because of various gastrointestinal conditions. It's not suitable for those with known heart rhythm problems or long QT syndrome, which is an abnormality seen on an EKG.Check my eligibility
What is being tested?
The study tests if Ondansetron can improve the bowel cleaning process before a colonoscopy in young patients. Participants are randomly chosen to receive either Ondansetron or no treatment to see which works better.See study design
What are the potential side effects?
Ondansetron may cause headaches, constipation, fatigue, or a warm sensation. Rarely, it could affect heart rhythms but this risk excludes individuals with known arrhythmias from the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Boston Bowel Preparation Scale
Secondary outcome measures
Symptoms associated with Bowel Prep

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OndansetronExperimental Treatment1 Intervention
Pediatric patients between the ages of 2-20 who have a clinical indication for colonoscopy, who will undergo standard colonoscopy preparation of polyethylene glycol and bisacodyl with the addition of one dose of ondansetron prior to initiating bowel preparation.
Group II: ControlActive Control1 Intervention
Pediatric patients between the ages of 2-20 who have a clinical indication for colonoscopy, who will undergo standard colonoscopy preparation of polyethylene glycol and bisacodyl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron
FDA approved

Find a Location

Who is running the clinical trial?

State University of New York - Downstate Medical CenterLead Sponsor
66 Previous Clinical Trials
12,558 Total Patients Enrolled
Thomas Wallach, MDPrincipal InvestigatorSUNY Downstate HSU

Media Library

Ondansetron Clinical Trial Eligibility Overview. Trial Name: NCT05439772 — Phase 4
Blood in Stool Research Study Groups: Control, Ondansetron
Blood in Stool Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT05439772 — Phase 4
Ondansetron 2023 Treatment Timeline for Medical Study. Trial Name: NCT05439772 — Phase 4
Blood in Stool Patient Testimony for trial: Trial Name: NCT05439772 — Phase 4
~9 spots leftby May 2025
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