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.