CompletedPhase 3

Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

Canada1,030 participantsStarted 2019-09-14

Plain-language summary

A phase III, double-blind, parallel-design, randomized, placebo-controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.

Who can participate

Age range

6 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willingness to comply with all study procedures and availability for the duration of the study. * Diagnosis of acute intestinal infectious process (as defined by the protocol) confirmed. by the treating physician. * Age 6 months to 17.99 years. * Presence of ≥ 3 episodes of vomiting in the preceding 24-hour period. * Duration of vomiting and/or diarrheal symptoms \< 72 hours. * A minimum of 1 episode of vomiting within 6 hours of the screening process performed by the research team. * A minimum of 1 dose of ondansetron (oral or intravenous) provided during the current emergency department visit. Exclusion Criteria: * Bilious or bloody vomit during current illness. * Known hypersensitivity to ondansetron or any serotonin receptor antagonist (e.g. palonosetron, dolasetron, granisetron). * Known allergic reaction to components of ondansetron (citric acid, sodium benzoate, sodium citrate dihydrate, and strawberry flavor, sorbitol) or the placebo medication (methylparaben, glycerin, citric acid, potassium sorbate, sorbitol, strawberry flavor). * History or family history (first degree relative) of prolonged QT syndrome. * Presence of complex congenital heart disease. * History or family history (first degree relative) of cardiac arrhythmia. * Concomitant use (within the past 48 hours) of any of the following: QTc prolonging medications, medications known to cause torsades de pointes, medications that cause electrolyte abnormalities, serotonergic or neurole…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Development of moderate to severe disease as defined by the Modified Vesikari Scale (MVS) Score of ≥ 9 following ED evaluation - change in the MVS score between Hour 0 and Hour 168 of the study.

Timeframe: Measured 24, 48, and 168 hours after baseline visit

Trial details

NCT IDNCT03851835

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-27

View on ClinicalTrials.gov More Acute Gastroenteritis trials

Who can participate

Age range

6 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.