drugset / Trial / NCT01843842

Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

NCT01843842 ↗

Phase 3 Completed 306 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is: * to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; * to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.

Timeline

Start
2013-04
Primary completion
2015-03
Completion
2015-03

Outcome

Met primary endpoint

registry analysis (superiority test); Ergoferon in Liquid Dosage Form vs Placebo; p = 0.016; Global Test Statistic NCT01843842 ↗

registry NUMBER Ergoferon in Liquid Dosage Form: Day 4: 44 percentage of participants NCT01843842 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ergoferon Protein / enzyme biologic 5 ml —