Clinical trial NCT01843842: Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Upper Respiratory Tract Infections
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 306
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
timeFrame: On day 2, 3 and 4 of observation
Secondary outcomes:
measure: Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
timeFrame: baseline and days 2, 3, 4 and 5 of observation
measure: Percentage of Patients With Normal Body Temperature (≤37.0ºС)
timeFrame: On day 2, 3, 4, 5 of observation
measure: 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)
timeFrame: on Days 2, 3, 4, 5 of Observation
measure: Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
timeFrame: baseline and days 2, 3, 4 and 5 of observation
measure: Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
timeFrame: On days 1-6 of observation
measure: Number of Intakes of Antipyretics if Indicated
timeFrame: On day 1, 2, 3, 4 and 5 of the treatment
measure: Percentage of Patients With Exacerbation of the Disease Course
timeFrame: On days 1-6 of observation
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Municipal Institution "Child Health City Hospital №11"
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation
city: Perm
country: Russian Federation
facility: Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
city: St. Peterburg
country: Russian Federation
facility: St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"
city: St. Petersburg
country: Russian Federation
facility: State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
city: St. Petersburg
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
city: St. Petersburg
country: Russian Federation
facility: State Health Care Institution "Child Health City Hospital №22"
city: St.Petersburg
country: Russian Federation
facility: Limited Liability Company "Alliance Biomedical-Russian group"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health
Study officials:
References: