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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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

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Acute Upper Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ergoferon (5 ml 3 times a day)

Group Type EXPERIMENTAL

Ergoferon

Intervention Type DRUG

Safety and Efficiency of liquid dosage form

Placebo (5 ml 3 times a day)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Safety and Efficiency of liquid dosage form

Interventions

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Ergoferon

Safety and Efficiency of liquid dosage form

Intervention Type DRUG

Placebo

Safety and Efficiency of liquid dosage form

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients of both sexes aged over 3 years and under 18 years.
2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
3. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
4. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
5. Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.

Exclusion Criteria

1. Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
2. Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
3. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
4. Medical history of sarcoidosis.
5. Oncological diseases.
6. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
7. Medical history of polyvalent allergy.
8. Allergy/ intolerance to any of the components of medications used in the treatment.
9. Impaired glucose tolerance, diabetes mellitus.
10. Hereditary fructose intolerance (as the study drug contains maltitol).
11. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
14. Mental disorders of patient or of patient's parents/adopters.
15. Patient's parents/ adopters, who from investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
16. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
17. Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
18. Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No