NCT03162458

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

Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 1 Month – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Upper Respiratory Infections

Interventions

Type	Name	Description
DRUG	Anaferon for children (liquid dosage form)	10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
DRUG	Placebo (liquid dosage form)	10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.

Timeline

• Start date: 2015-01-22
• Primary completion: 2015-04-29
• Completion: 2015-04-29
• First posted: 2017-05-22
• Last updated: 2018-11-28
• Results posted: 2018-08-03

Locations

7 sites across 1 country: Russia