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

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ClinicalTrials.gov Identifier: NCT01804946
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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

Condition or disease Intervention/treatment Phase
Influenza Drug: Ergoferon Drug: Oseltamivir Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Study Start Date : February 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: 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.
Drug: Ergoferon
Safety and Efficiency of Ergoferon in treatment of Influenza

Active Comparator: Oseltamivir(Tamiflu): 75 mg two times a day.
Oseltamivir for 5 days (75 mg b.i.d.).
Drug: Oseltamivir
Safety and Efficiency in treatment of Influenza
Other Name: Tamiflu




Primary Outcome Measures :
  1. Percentage of Patients With Normal Body Temperature [ Time Frame: Day 1 to Day 5 ]
    Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)


Secondary Outcome Measures :
  1. Percentage of Patients With Resolution of Influenza Symptoms [ Time Frame: on the day 7 of the observation ]
    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

  2. Time to Resolution of the Influenza [ Time Frame: Day 1 to Day 7 ]

    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.


  3. Mean Body Temperature [ Time Frame: on days 1, 3 and 7 of the observation ]
    The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)

  4. Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms) [ Time Frame: on days 1, 3 and 7 of the observation ]
    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)

  5. The Number of the Antipyretic Intake [ Time Frame: Day 1 to Day 5 ]
    A subject recorded the number of antipyretic intake in patient diary.

  6. Change in the Patient's Quality of Life. [ Time Frame: Day 7 vs. Day 1 ]
    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).

  7. Change in the Subjective Health Status [ Time Frame: Day 7 vs. Day 1 ]
    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).

  8. Percentage of Patients With Complications of the Influenza [ Time Frame: Day 1 to Day 7 ]
    Pneumonia, sinusitis, otitis media are examples of the influenza complications



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804946


Locations
Russian Federation
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, Russian Federation, 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, Russian Federation, 117997
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, Russian Federation, 129090
State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Smolensk, Russian Federation, 214019
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
St. Petersburg, Russian Federation, 198328
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
St. Petersburg, Russian Federation
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, Russian Federation, 394036
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Yaroslavl, Russian Federation, 150000
Sponsors and Collaborators
Materia Medica Holding
Investigators
Study Director: Mikhail Putilovskiy, MD, PhD Materia Medica Holding

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01804946     History of Changes
Other Study ID Numbers: MMH-ER-001
First Posted: March 5, 2013    Key Record Dates
Results First Posted: June 23, 2015
Last Update Posted: June 23, 2015
Last Verified: March 2013

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action