Status:
COMPLETED
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Women and Children's Health Research Institute (WCHRI)
Conditions:
Acute Gastroenteritis
Viral Illness
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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),...
Detailed Description
The annual burden of acute gastroenteritis in the United States includes 17 million related episodes and 473,832 hospitalizations. Although oral-rehydration therapy is recommended for children with mi...
Eligibility Criteria
Inclusion
- 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
- 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.
- History or family history of G6PD deficiency.
Key Trial Info
Start Date :
September 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2024
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT03851835
Start Date
September 14 2019
End Date
July 6 2024
Last Update
April 25 2025
Active Locations (6)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2C8
3
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3A 1S1
4
Children's Hospital London Health Sciences Centre
London, Ontario, Canada, N6A 5W9