Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

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.

Conditions

• Acute Gastroenteritis
• Viral Illness
• Vomiting
• Diarrhea

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Women and Children's Health Research Institute (WCHRI)

  collaborator UNKNOWN

• The Hospital for Sick Children

  collaborator OTHER

• Children's Hospital Research Institute of Manitoba

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Alberta Children's Hospital Research Institute

  collaborator OTHER

• Western University, Canada

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Stephen Freedman, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-14

Primary Completion

2024-06-27

Completion

2024-07-06

Countries

• Canada

Study Locations