Status:
COMPLETED
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Lead Sponsor:
Materia Medica Holding
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- Patients of both sexes aged from 18 to 60 inclusively.
- 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.
- Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
- The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
- Signed Informed Consent form for participation in the study.
Exclusion
- Patients aged below 18 years and above 60 years.
- Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
- Vaccination against influenza prior to epidemic season onset.
- Medical history of polyvalent allergy.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
- Chronic renal insufficiency.
- Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
- Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
- Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
- 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.
- Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
- 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.
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01804946
Start Date
February 1 2011
End Date
October 1 2014
Last Update
June 23 2015
Active Locations (8)
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1
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, Russia, 105064
2
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, 117997
3
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, Russia, 129090
4
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
Saint Petersburg, Russia, 198328