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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.).
Safety and Efficiency in treatment of Influenza
Other Name: Tamiflu
- 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)
- 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
- 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.
- 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)
- 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)
- The Number of the Antipyretic Intake [ Time Frame: Day 1 to Day 5 ]A subject recorded the number of antipyretic intake in patient diary.
- 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).
- 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).
- 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
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
|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|
|Study Director:||Mikhail Putilovskiy, MD, PhD||Materia Medica Holding|