drugset / Trial / NCT03162458

Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

NCT03162458 ↗

Phase 3 Completed 142 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose of the study: * To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections. * To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.

Timeline

Start
2015-01-22
Primary completion
2015-04-29
Completion
2015-04-29

Outcome

Met primary endpoint

registry MEAN Anaferon for Children: 87.7 (Standard Deviation 31.5) hours NCT03162458 ↗

registry analysis (superiority test); Anaferon for Children vs Placebo; p = 0.007; Wilcoxon (Mann-Whitney) NCT03162458 ↗

registry MEAN Anaferon for Children: 25.6 (Standard Deviation 17.2) AUC score*day NCT03162458 ↗

registry analysis (superiority test); Anaferon for Children vs Placebo; p = 0.0004; Wilcoxon (Mann-Whitney) NCT03162458 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Anaferon Unknown 10 unknown —