Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,030

Participants

Timeline

Start Date

September 14, 2019

Primary Completion Date

June 27, 2024

Study Completion Date

July 6, 2024

Conditions
Acute GastroenteritisViral IllnessVomitingDiarrhea
Interventions
DRUG

Ondansetron Oral Solution

Six doses of oral ondansetron (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24 hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed.

DRUG

Oral Placebo

Six doses of oral placebo (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24-hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed.

Trial Locations (6)

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2C8

Stollery Children's Hospital, Edmonton

R3A 1S1

Children's Hospital of Winnipeg, Winnipeg

N6A 5W9

Children's Hospital London Health Sciences Centre, London

K1H 8L1

Children's Hospital of Eastern Ontario (CHEO), Ottawa

HT3 1C5

Centre Hospitalier Universitaire Sainte Justine, Montreal

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Women and Children's Health Research Institute (WCHRI)

UNKNOWN

collaborator

The Hospital for Sick Children

OTHER

collaborator

Children's Hospital Research Institute of Manitoba

OTHER

collaborator

University of Manitoba

OTHER

collaborator

Université de Montréal

OTHER

collaborator

University of Ottawa

OTHER

collaborator

University of Alberta

OTHER

collaborator

Alberta Children's Hospital Research Institute

OTHER

collaborator

Western University, Canada

OTHER

lead

University of Calgary

OTHER

NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis | Biotech Hunter | Biotech Hunter