Examining the Effect of Ondansetron on Bowel Prep Success

NCT05439772 | Completed Phase 4 FDA Drug

• 1 other identifier: 1650686-6
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic Gastroenteritis; Diarrhea; Hematochezia; Weight Loss

Keywords

colonoscopy; bowel preparation; ondansetron

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale

  validated scoring system of bowel preparation

  24 hours after dose

Secondary Outcomes (1)

• Symptoms associated with Bowel Prep

  24 hours after dose

Study Arms (2)

Control

NO 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

Ondansetron

EXPERIMENTAL

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.

Drug: Ondansetron

Interventions

Ondansetron DRUG

Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

Also known as: Zofran

Ondansetron

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \>2, \<20
• clinically indicated for a colonoscopy

You may not qualify if:

• known arrhythmia or long QT

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate University Hospital of Brooklyn

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• Arostegui D, Armaly P, Castro Ochoa K, Lemus VV, Peshimam J, Sharma S, Schwarz S, Wallach T. Pilot Study of Ondansetron in Improvement of Pediatric Colonoscopy Preparation Outcomes at an Urban Academic Center. JPGN Rep. 2023 Sep 8;4(4):e366. doi: 10.1097/PG9.0000000000000366. eCollection 2023 Nov.

  PMID: 38034452 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic enteropathy; Diarrhea; Gastrointestinal Hemorrhage; Weight Loss

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hemorrhage; Pathologic Processes; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Thomas Wallach, MD

  SUNY Downstate HSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-blinded randomized control trial

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 30, 2022
• Study Start: January 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)