Clinical trial

Examining the Effect of Ondansetron on Bowel Prep Success

Name

1650686-6

Description

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.

Trial arms

Trial start

2021-01-01

Estimated PCD

2023-07-01

Trial end

2023-07-01

Status

Completed

Phase

Early phase I

Treatment

Ondansetron

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

Arms:

Ondansetron

Size

Primary endpoint

Boston Bowel Preparation Scale

24 hours after dose

Eligibility criteria

Inclusion Criteria: * Age \>2, \<20 * clinically indicated for a colonoscopy Exclusion Criteria: * known arrhythmia or long QT

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non-blinded randomized control trial', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}

Updated at

2023-12-20

1 organization

1 product

6 indications

Organization

State University of New York - Downstate Medical Center

Product

Ondansetron

Indication

Abdominal Pain

Indication