drugset / Trial / NCT03851835
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
Phase 3
Completed
1030 enrolled
University of Calgary
Alberta Children's Hospital Research Institute · collabCanadian Institutes of Health Research (CIHR) · collabChildren's Hospital Research Institute of Manitoba · collabThe Hospital for Sick Children · collabUniversity of Alberta · collabUniversity of Manitoba · collabUniversity of Ottawa · collabUniversité de Montréal · collabWestern University, Canada · collabWomen and Children's Health Research Institute, Canada · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-09-14
- Primary completion
- 2024-06-27
- Completion
- 2024-07-06
Outcome
Met primary endpoint
paper ondansetron was associated with a lower risk of moderate-to-severe gastroenteritis than placebo (adjusted odds ratio, 0.50; 95% CI, 0.40 to 0.60). PMID 40673584 ↗
Publications
- Sumner M, Xie J, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Finkelstein Y, Pechlivanoglou P, Klassen T, Freedman SB; Pediatric Emergency Research Canada (PERC). Persistent Vomiting Among Children With Acute Gastroenteritis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610898. doi: 10.1001/jamanetworkopen.2026.10898.
- Freedman SB, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Pechlivanoglou P, Finkelstein Y, Heath A, Zhang JZ, Wallace A, Offringa M, Klassen TP; Pediatric Emergency Research Canada Innovative Clinical Trials Study Group. Multidose Ondansetron after Emergency Visits in Children with Gastroenteritis. N Engl J Med. 2025 Jul 17;393(3):255-266. doi: 10.1056/NEJMoa2503596.
- Heath A, Rios JD, Williamson-Urquhart S, Pechlivanoglou P, Offringa M, McCabe C, Hopkin G, Plint AC, Dixon A, Beer D, Gouin S, Joubert G, Klassen TP, Freedman SB; PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials. 2020 Aug 24;21(1):735. doi: 10.1186/s13063-020-04651-1.
- Freedman SB, Williamson-Urquhart S, Heath A, Pechlivanoglou P, Hopkin G, Gouin S, Plint AC, Dixon A, Beer D, Joubert G, McCabe C, Finkelstein Y, Klassen TP; KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group. Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial. Trials. 2020 May 27;21(1):435. doi: 10.1186/s13063-020-04347-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ondansetron | Other / unclassified | 0.15 mg/kg | Oral |