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

NCT03162458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-11-28

Study results available
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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

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.

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162458 on ClinicalTrials.gov