Ondansetron for Hematochezia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
SUNY Downstate University Hospital of Brooklyn, Brooklyn, NY
Hematochezia+8 More
Ondansetron - Drug
Eligibility
< 65
All Sexes
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Study Summary

This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

Eligible Conditions

  • Hematochezia
  • Eosinophilic Gastroenteritis
  • Inflammatory Bowel Diseases
  • Diarrhea
  • Weight Loss
  • Colicky Pain

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Hematochezia

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 24 hours after dose

24 hours after dose
Boston Bowel Preparation Scale
Symptoms associated with Bowel Prep

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Hematochezia

Side Effects for

Ondansetron
2%Deep Vein Thrombosis
2%Cerebrospinal fluid leak
2%Fever
0%Cerebrovascular Hematoma
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Deep Vein Thrombosis with 2%, Cerebrospinal fluid leak with 2%, Fever with 2%, Cerebrovascular Hematoma with 0%.

Trial Design

2 Treatment Groups

Control
1 of 2
Ondansetron
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Ondansetron · No Placebo Group · Phase 4

Ondansetron
Drug
Experimental Group · 1 Intervention: Ondansetron · Intervention Types: Drug
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron
2011
Completed Phase 4
~4010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours after dose
Closest Location: SUNY Downstate University Hospital of Brooklyn · Brooklyn, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2018First Recorded Clinical Trial
1 TrialsResearching Hematochezia
2 CompletedClinical Trials

Who is running the clinical trial?

State University of New York - Downstate Medical CenterLead Sponsor
58 Previous Clinical Trials
9,874 Total Patients Enrolled
Thomas Wallach, MDPrincipal InvestigatorSUNY Downstate HSU

Eligibility Criteria

Age < 65 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.