Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Materia Medica

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Drug: Ergoferon; Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01804946

MMH-ER-001

Details and patient eligibility

About

The purpose of this study is:

• to assess clinical efficiency of Ergoferon for treatment of influenza
• to assess safety of Ergoferon for treatment of influenza
• to compare efficiency of Ergoferon and Tamiflu for treatment of influenza

Enrollment: 161 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of both sexes aged from 18 to 60 inclusively.
2. Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
4. The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
5. Signed Informed Consent form for participation in the study.

Exclusion criteria

1. Patients aged below 18 years and above 60 years.
2. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
3. Vaccination against influenza prior to epidemic season onset.
4. Medical history of polyvalent allergy.
5. Allergy/ intolerance to any of the components of medications used in the treatment.
6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
7. Chronic renal insufficiency.
8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
11. Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
12. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
13. The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
14. The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

Ergoferon (1 tablet 3 times a day)

Experimental group

Description:

1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.

Treatment:

Drug: Ergoferon

Oseltamivir(Tamiflu): 75 mg two times a day.

Active Comparator group

Description:

Oseltamivir for 5 days (75 mg b.i.d.).

Treatment:

Drug: Oseltamivir