CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,030 enrolled
Drug / intervention
Ondansetron Oral Solution +1 moredrug
Likely dose
Ondansetron Oral Solution 0.15mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03851835
NCT03851835Phase 3Completed
CompareCT.gov

Multi-dose Oral Ondansetron For Pediatric Gastroenteritis: A Pragmatic Randomized Controlled Trial

University of Calgary·interventional·Posted Feb 22, 2019·Updated Apr 25, 2025

In Brief

A Phase 3 clinical trial evaluating Ondansetron Oral Solution and Oral Placebo for Acute Gastroenteritis and 3 related conditions. Completed, enrolled 1,030 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Gastroenteritis, Viral Illness, Vomiting, Diarrhea
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR), Women and Children's Health Research Institute, Canada, The Hospital for Sick Children, Children's Hospital Research Institute of Manitoba, University of Manitoba, Université de Montréal, University of Ottawa, University of Alberta, Alberta Children's Hospital Research Institute, Western University, Canada

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 22, 2019
Enrollment StartSep 14, 2019
Primary CompletionJun 27, 2024
Study CompletionJul 6, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.4 years ago

Interventions

Ondansetron Oral Solutiondrug

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.

Oral Placebodrug

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.