Leitz G, et al. - Through a randomized, double-blind, phase 3 study done on the basis of a request from the European Medicines Agency, of 292 children aged 6 months to 12 years with acute gastroenteritis, to create strong data on domperidone efficiency in children in the relief of symptoms of nausea and vomiting by evaluating the impact of a low-dose and short treatment span. Between domperidone and the placebo group, the proportion of patients with no vomiting events within 48-hours of first treatment administration was comparable. Furthermore, no important variation in proportion of patients aged ≥ 4 years with no nausea incidents within 48 hours of first treatment administration between domperidone and placebo was noted. A total of 13 patients listed ≥ 1 treatment-emergent adverse events. No deaths or adverse events of particular concern were recorded. Thus, in pediatric patients with acute gastroenteritis, low-dose of domperidone with oral rehydration therapy did not significantly vary from placebo in decreasing vomiting and nausea events, and the safety profile was comparable between both groups.