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 aged 6-months to 12-years with acute gastroenteritis randomly (1:1) received oral domperidone 0.25-mg/kg plus oral rehydration therapy (ORT) or matching placebo thrice-daily for 2-7 days. The proportion of patients with no vomiting episodes (primary endpoint) and patients aged ≥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 aged ≥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] versus placebo, 5.5% [8/145]) reported ≥1 treatment-emergent adverse events. No deaths or adverse events of special interest (extrapyramidal symptoms and QT prolongation)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 292 participants or records.
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