Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    161
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
Study Started
Feb 28
2011
Primary Completion
Apr 30
2014
Study Completion
Oct 31
2014
Results Posted
Jun 23
2015
Estimate
Last Update
Jun 23
2015
Estimate

Drug Ergoferon

Safety and Efficiency of Ergoferon in treatment of Influenza

Drug Oseltamivir

Safety and Efficiency in treatment of Influenza

  • Other names: Tamiflu

Ergoferon (1 tablet 3 times a day) Experimental

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.

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

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

Criteria

Inclusion Criteria:

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 Criteria:

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.

Summary

Ergoferon Group

Oseltamivir Group

All Events

Event Type Organ System Event Term Ergoferon Group Oseltamivir Group

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)

Ergoferon Group (EG)

Evening, Day 1

4.0
Percentage of participants

Evening, Day 2

15.0
Percentage of participants

Evening, Day 3

41.0
Percentage of participants

Evening, Day 4

68.0
Percentage of participants

Evening, Day 5

84.0
Percentage of participants

Oseltamivir Goup (OG)

Evening, Day 1

1.0
Percentage of participants

Evening, Day 2

15.0
Percentage of participants

Evening, Day 3

43.0
Percentage of participants

Evening, Day 4

72.0
Percentage of participants

Evening, Day 5

88.0
Percentage of participants

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

Ergoferon Group

All symptoms

47.0
Percentage of participants

Common symptoms

61.0
Percentage of participants

Fever

100.0
Percentage of participants

Respiratory symptoms

83.0
Percentage of participants

Oseltamivir Group

All symptoms

49.0
Percentage of participants

Common symptoms

64.0
Percentage of participants

Fever

100.0
Percentage of participants

Respiratory symptoms

76.0
Percentage of participants

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.

Ergoferon Group

All influenza symptoms

2.6
Days (Mean)
Standard Deviation: 2.3

Common symptoms

2.6
Days (Mean)
Standard Deviation: 2.2

Fever

2.1
Days (Mean)
Standard Deviation: 1.4

Respiratory symptoms

2.7
Days (Mean)
Standard Deviation: 2.5

Oseltamivir Group

All influenza symptoms

2.5
Days (Mean)
Standard Deviation: 2.2

Common symptoms

2.4
Days (Mean)
Standard Deviation: 2.1

Fever

2.3
Days (Mean)
Standard Deviation: 1.6

Respiratory symptoms

2.6
Days (Mean)
Standard Deviation: 2.6

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)

Ergoferon Group

Axillary temperature, Day 1

38.3
°C (Mean)
Standard Deviation: 0.4

Axillary temperature, Day 3

37.0
°C (Mean)
Standard Deviation: 0.5

Axillary temperature, Day 7

36.5
°C (Mean)
Standard Deviation: 0.2

Oseltamivir Group

Axillary temperature, Day 1

38.3
°C (Mean)
Standard Deviation: 0.4

Axillary temperature, Day 3

37.0
°C (Mean)
Standard Deviation: 0.5

Axillary temperature, Day 7

36.6
°C (Mean)
Standard Deviation: 0.3

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)

Ergoferon Group

Common symptoms, Day 1

19.0
Scores on a scale (Mean)
Standard Deviation: 6.7

Common symptoms, Day 3

9.2
Scores on a scale (Mean)
Standard Deviation: 5.1

Common symptoms, Day 7

2.3
Scores on a scale (Mean)
Standard Deviation: 2.7

Respiratory symptoms, Day 1

6.1
Scores on a scale (Mean)
Standard Deviation: 3.7

Respiratory symptoms, Day 3

4.3
Scores on a scale (Mean)
Standard Deviation: 2.4

Respiratory symptoms, Day 7

1.3
Scores on a scale (Mean)
Standard Deviation: 1.5

Oseltamivir Group

Common symptoms, Day 1

18.6
Scores on a scale (Mean)
Standard Deviation: 6.3

Common symptoms, Day 3

7.8
Scores on a scale (Mean)
Standard Deviation: 4.3

Common symptoms, Day 7

1.9
Scores on a scale (Mean)
Standard Deviation: 2.3

Respiratory symptoms, Day 1

5.9
Scores on a scale (Mean)
Standard Deviation: 3.6

Respiratory symptoms, Day 3

4.0
Scores on a scale (Mean)
Standard Deviation: 2.7

Respiratory symptoms, Day 7

1.4
Scores on a scale (Mean)
Standard Deviation: 1.8

The Number of the Antipyretic Intake

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

Ergoferon Group

Day 1

0.65
Number of Doses (Mean)
Standard Deviation: 0.48

Day 2

0.4
Number of Doses (Mean)
Standard Deviation: 0.49

Day 3

0.19
Number of Doses (Mean)
Standard Deviation: 0.39

Day 4

0.01
Number of Doses (Mean)
Standard Deviation: 0.12

Day 5

Oseltamivir Group

Day 1

0.72
Number of Doses (Mean)
Standard Deviation: 0.45

Day 2

0.49
Number of Doses (Mean)
Standard Deviation: 0.50

Day 3

0.15
Number of Doses (Mean)
Standard Deviation: 0.36

Day 4

0.03
Number of Doses (Mean)
Standard Deviation: 0.17

Day 5

0.01
Number of Doses (Mean)
Standard Deviation: 0.12

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).

Ergoferon Group

Day 1

9.5
Scores on a scale (Mean)
Standard Deviation: 1.9

Day 7

5.4
Scores on a scale (Mean)
Standard Deviation: 0.9

Oseltamivir Group

Day 1

9.4
Scores on a scale (Mean)
Standard Deviation: 2.2

Day 7

5.4
Scores on a scale (Mean)
Standard Deviation: 0.8

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).

Ergoferon Group

Day 1

41.6
Scores on a scale (Mean)
Standard Deviation: 18.2

Day 7

87.7
Scores on a scale (Mean)
Standard Deviation: 10.7

Oseltamivir Group

Day 1

46.2
Scores on a scale (Mean)
Standard Deviation: 15.4

Day 7

88.0
Scores on a scale (Mean)
Standard Deviation: 10.6

Percentage of Patients With Complications of the Influenza

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

Ergoferon Group

Oseltamivir Group

2.0
Percentage of participants

Total

161
Participants

Age, Continuous

34.7
years (Mean)
Standard Deviation: 12.1

Region of Enrollment

Sex: Female, Male

Overall Study

Ergoferon Group (EG)

Oseltamivir Group (OG)

Drop/Withdrawal Reasons

Ergoferon Group (EG)

Oseltamivir Group (OG)