Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
1 other identifier
interventional
161
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2011
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
June 23, 2015
CompletedJune 23, 2015
March 1, 2013
3.2 years
March 4, 2013
April 13, 2015
June 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Normal Body Temperature
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Day 1 to Day 5
Secondary Outcomes (8)
Percentage of Patients With Resolution of Influenza Symptoms
on the day 7 of the observation
Time to Resolution of the Influenza
Day 1 to Day 7
Mean Body Temperature
on days 1, 3 and 7 of the observation
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
on days 1, 3 and 7 of the observation
The Number of the Antipyretic Intake
Day 1 to Day 5
- +3 more secondary outcomes
Study Arms (2)
Ergoferon (1 tablet 3 times a day)
EXPERIMENTAL1 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.
Oseltamivir(Tamiflu): 75 mg two times a day.
ACTIVE COMPARATOROseltamivir for 5 days (75 mg b.i.d.).
Interventions
Safety and Efficiency of Ergoferon in treatment of Influenza
Safety and Efficiency in treatment of Influenza
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, 105064, 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, 117997, Russia
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, 129090, Russia
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
Saint Petersburg, 198328, 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, 214019, 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, 394036, Russia
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Yaroslavl, 150000, Russia
Related Publications (1)
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.
PMID: 27616034DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
- Organization
- Materia Medica Holding
Study Officials
- STUDY DIRECTOR
Mikhail Putilovskiy, MD, PhD
Materia Medica Holding
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 5, 2013
Study Start
February 1, 2011
Primary Completion
April 1, 2014
Study Completion
October 1, 2014
Last Updated
June 23, 2015
Results First Posted
June 23, 2015
Record last verified: 2013-03