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

NCT01843842 | Completed Phase 3 Results

• 1 other identifier: MMH-ER-007
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Acute Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)

  Based on the data mentioned in a patient's diary

  On day 2, 3 and 4 of observation

Secondary Outcomes (7)

• Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)

  baseline and days 2, 3, 4 and 5 of observation

• Percentage of Patients With Normal Body Temperature (≤37.0ºС)

  On day 2, 3, 4, 5 of observation

• Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)

  on Days 2, 3, 4, 5 of Observation

• Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data

  baseline and days 2, 3, 4 and 5 of observation

• Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)

  On days 1-6 of observation

Study Arms (2)

Ergoferon (5 ml 3 times a day)

EXPERIMENTAL

Drug: Ergoferon

Placebo (5 ml 3 times a day)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ergoferon DRUG

Safety and Efficiency of liquid dosage form

Ergoferon (5 ml 3 times a day)

Placebo DRUG

Safety and Efficiency of liquid dosage form

Placebo (5 ml 3 times a day)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of both sexes aged over 3 years and under 18 years.
• 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.
• The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
• 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.
• 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.

You may not qualify if:

• Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
• 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).
• 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.
• Medical history of sarcoidosis.
• Oncological diseases.
• Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
• Medical history of polyvalent allergy.
• Allergy/ intolerance to any of the components of medications used in the treatment.
• Impaired glucose tolerance, diabetes mellitus.
• Hereditary fructose intolerance (as the study drug contains maltitol).
• Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
• Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
• Mental disorders of patient or of patient's parents/adopters.
• 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.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (11)

State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"

Moscow, 119992, Russia

Location

State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation

Novosibirsk, 630091, Russia

Location

Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"

Perm, 614066, Russia

Location

St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"

Saint Peterburg, 193312, Russia

Location

State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"

Saint Petersburg, 191144, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"

Saint Petersburg, 192212, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation

Saint Petersburg, 194100, Russia

Location

Limited Liability Company "Alliance Biomedical-Russian group"

Saint Petersburg, 194356, Russia

Location

State Health Care Institution "Child Health City Hospital №22"

Saint Petersburg, 196650, Russia

Location

State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health

Yaroslavl, 150000, Russia

Location

Municipal Institution "Child Health City Hospital №11"

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761575

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 29, 2018
• Results First Posted: August 3, 2018

Record last verified: 2018-11

Locations

RU (11)