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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%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
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
65 Previous Clinical Trials
12,510 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration (FDA) sanctioned Ondansetron?

"As Ondansetron is an approved medication, it has been given a rating of 3 on our 1-3 scale to denote its safety."

Answered by AI

Is there still room to enroll in this research project?

"According to the details listed on clinicaltrials.gov, this trial is presently accepting participants and was first posted online on January 1st 2021 with an update on June 28th 2022."

Answered by AI

Who qualifies as a potential participant for this clinical experiment?

"This experiment is looking for 50 participants, aged between two and twenty, who present with hematochezia. Furthermore, all subjects must be of suitable age to undergo colonoscopy and have a medical indication to do so."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. The clinical trial data hosted on the official website displays that, since its inception in January 1st 2021 and most recent amendment on June 28th 2022, this research is currently searching for 50 subjects at a single location."

Answered by AI

Is there an upper age limit to enrolling in this trial?

"According to the given inclusion criteria, only those between 2 and 20 years of age can be accepted into this trial. There are 125 trials involving individuals under 18 and 393 studies targeting over 65s."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
South Carolina
What site did they apply to?
SUNY Downstate University Hospital of Brooklyn
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried everything to lose weight but I am hoping that this will work.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Examining the Effect of Ondansetron on Bowel Prep Success
Thomas Wallach 2021. "Examining the Effect of Ondansetron on Bowel Prep Success". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05439772.
~10 spots leftby Apr 2025
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