Overview

Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Calgary
Collaborators:
Alberta Children's Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Children's Hospital Research Institute of Manitoba
The Hospital for Sick Children
Université de Montréal
University of Alberta
University of Manitoba
University of Ottawa
University of Western Ontario, Canada
Women and Children's Health Research Institute (WCHRI)
Treatments:
Ondansetron
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Diagnosis of acute intestinal infectious process (as defined by the protocol)
confirmed. by the treating MD.

- 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 neuroleptic medications, or any 5-HT3
receptor antagonist excluding ondansetron.

- Unable to complete follow-up.

- Previously enrolled in this study.