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

NCT ID: NCT01804946

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-10-31

Brief Summary

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ergoferon (1 tablet 3 times a day)

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.

Group Type: EXPERIMENTAL

Ergoferon

Intervention Type: DRUG

Safety and Efficiency of Ergoferon in treatment of Influenza

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

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

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: DRUG

Safety and Efficiency in treatment of Influenza

Interventions

Ergoferon

Safety and Efficiency of Ergoferon in treatment of Influenza

Intervention Type: DRUG

Oseltamivir

Safety and Efficiency in treatment of Influenza

Intervention Type: DRUG

Other Intervention Names

Tamiflu

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhail Putilovskiy, MD, PhD

Role: STUDY_DIRECTOR

Materia Medica Holding

Locations

Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science

Moscow, , Russia

State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" of Ministry of Health and Social Development of Russian Federation

Moscow, , Russia

Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation

Moscow, , Russia

St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"

Saint Petersburg, , Russia

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"

Saint Petersburg, , Russia

State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation

Smolensk, , Russia

State Educational Institution of Higher Professional Education "Voronezh State Academy named after N.N. Burdenko" of Ministry of Health and Social Development of Russian Federation

Voronezh, , Russia

State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation

Yaroslavl, , Russia

Countries

Russia

References

Rafalsky V, Averyanov A, Bart B, Minina E, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Ergoferon versus oseltamivir in adult outpatients with seasonal influenza virus infection: a multicenter, open-label, randomized trial. Int J Infect Dis. 2016 Oct;51:47-55. doi: 10.1016/j.ijid.2016.09.002. Epub 2016 Sep 8.

Reference Type: DERIVED

PMID: 27616034 (View on PubMed)

Other Identifiers

MMH-ER-001

Identifier Type: -

Identifier Source: org_study_id