Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children.

Abstract

BACKGROUND:

This study was conducted based on a request from the European Medicines Agency to generate robust data on domperidone efficacy in children in the relief of symptoms of nausea and vomiting by assessing the effect of a low-dose and short treatment duration.

METHODS:

In this randomized, double-blind, phase 3 study, children ages 6 months to 12 years with acute gastroenteritis randomly (1:1) received oral domperidone 0.25 mg/kg with oral rehydration therapy (ORT) or matching placebo thrice daily for 2 to 7 days. The proportion of patients with no vomiting episodes (primary endpoint) and patients ages ≥4 years with no nausea episodes (key secondary endpoint) within 48 hours of first treatment administration were evaluated.

RESULTS:

The study was terminated early following futility analysis. At early termination, 292 patients randomly received domperidone (n = 147) or placebo (n = 145). The proportion of patients with no vomiting episodes within 48-hours of first treatment administration was similar between domperidone (32.0%) and placebo groups (33.8%). Similarly, there was no significant difference in proportion of patients ages ≥4 years with no nausea episodes within 48 hours of first treatment administration between domperidone (35.7%) and placebo (38.6%). Total 13 patients (domperidone, 3.4% [5/147] vs placebo, 5.5% [8/145]) reported ≥1 treatment-emergent adverse events. No deaths or adverse events of special interest (extrapyramidal symptoms and QT prolongation) were reported.

CONCLUSIONS:

Low-dose of domperidone with ORT did not significantly differ from placebo in reducing vomiting and nausea episodes in pediatric patients with acute gastroenteritis (AG), and the safety profile was similar between both groups.

• Authors: Gerhard Leitz, Peter Hu, Carlos Appiani, Qing Li, Essack Mitha, Maria Garces-Sanchez, Rajeev Gupta
• Journal: Journal of pediatric gastroenterology and nutrition (J Pediatr Gastroenterol Nutr) Vol. 69 Issue 4 Pg. 425-430 (10 2019) ISSN: 1536-4801 [Electronic] United States
• PMID: 31181017 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiemetics
• Domperidone

Topics

• Acute Disease
• Administration, Oral
• Antiemetics (administration & dosage, therapeutic use)
• Child
• Child, Preschool
• Domperidone (administration & dosage, therapeutic use)
• Double-Blind Method
• Europe
• Female
• Gastroenteritis (complications)
• Humans
• Infant
• Male
• Nausea (complications, drug therapy)
• Russia
• South Africa
• Treatment Outcome
• Vomiting (complications, drug therapy)