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InfluenzaPhase 4NCT01804946

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

A Phase 4 study testing Ergoferon and Oseltamivir in people with Influenza, run by Materia Medica Holding at 8 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Influenza
What is being tested?
Ergoferon and Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
8 sitesRussia
Study dates
Feb 2011to Oct 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Russia8 sites

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

    Moscow, 105064

  • 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

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

    Moscow, 129090

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

    Saint Petersburg, 198328

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

    Saint Petersburg

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

    Smolensk, 214019

  • 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

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

    Yaroslavl, 150000

Other trials in Russia

About this study

Official title: Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

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
Being tested
Ergoferon, Oseltamivir
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErgoferonDrug

    Safety and Efficiency of Ergoferon in treatment of Influenza

  • OseltamivirDrug

    Also called Tamiflu

    Safety and Efficiency in treatment of Influenza

Study groups in NCT01804946
Study groupRoleWhat they receive
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.
Receives: Drug: Ergoferon
Oseltamivir(Tamiflu): 75 mg two times a day.Active comparatorOseltamivir for 5 days (75 mg b.i.d.).
Receives: Drug: Oseltamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Day 1 to Day 5

Secondary outcomes (8)

  1. Percentage of Patients With Resolution of Influenza Symptoms

    Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom

    Measured: on the day 7 of the observation

  2. Time to Resolution of the Influenza

    Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.

    The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.

    Measured: Day 1 to Day 7

  3. Mean Body Temperature

    The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)

    Measured: on days 1, 3 and 7 of the observation

  4. Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)

    The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)

    Measured: on days 1, 3 and 7 of the observation

  5. The Number of the Antipyretic Intake

    A subject recorded the number of antipyretic intake in patient diary.

    Measured: Day 1 to Day 5

  6. Change in the Patient's Quality of Life.

    The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).

    Measured: Day 7 vs. Day 1

  7. Change in the Subjective Health Status

    The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).

    Measured: Day 7 vs. Day 1

  8. Percentage of Patients With Complications of the Influenza

    Pneumonia, sinusitis, otitis media are examples of the influenza complications

    Measured: Day 1 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2013 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01804946
Sponsor's protocol ID
MMH-ER-001
Status last verified
Mar 2013
First submitted
4 Mar 2013
Last updated
23 Jun 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 27616034

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ergoferon and Oseltamivir in people with Influenza, run by Materia Medica Holding at 8 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Normal Body Temperature (time frame: Day 1 to Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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