NCT01843842

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

Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).

Conditions

• Acute Upper Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Ergoferon	Safety and Efficiency of liquid dosage form
DRUG	Placebo	Safety and Efficiency of liquid dosage form

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-05-01
• Last updated: 2018-11-29
• Results posted: 2018-08-03

Locations

11 sites across 1 country: Russia