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The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergoferon | Drug | Safety and Efficiency of Ergoferon in treatment of Influenza |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | on the day 7 of the observation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Putilovskiy, MD, PhD | Materia Medica Holding | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27616034 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergoferon Group (EG) | Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d. |
| FG001 | Oseltamivir Group (OG) | Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS included 78 patients per group: 5 patients excluded with the entry criteria violations (3, EG; 1, OG) and the lack of data (1, OG). PPSet contained 75 patients in EG and 72 ones in OG: 9 were excluded due to protocol violation (3, EG; 2, OG), the failure to satisfy not major entry criteria (3, OG) and due to assigning a prohibited drug (1, OG).
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergoferon Group (EG) | 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. Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented. | Posted | Number | Percentage of participants | Day 1 to Day 5 |
|
Adverse/Serious adverse events were registered from Day 1 to Day 7 and during 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=161, Safety Population)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ergoferon Group | Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 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 t.i.d. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials | Materia Medica Holding | +74952761575 | 302 | PutilovskiyMA@materiamedica.ru |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000621422 | ergoferon |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Oseltamivir | Drug | Safety and Efficiency in treatment of Influenza |
|
|
| 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. | Day 1 to Day 7 |
| 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) | on days 1, 3 and 7 of the observation |
| 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) | on days 1, 3 and 7 of the observation |
| The Number of the Antipyretic Intake | A subject recorded the number of antipyretic intake in patient diary. | Day 1 to Day 5 |
| 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). | Day 7 vs. Day 1 |
| 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). | Day 7 vs. Day 1 |
| Percentage of Patients With Complications of the Influenza | Pneumonia, sinusitis, otitis media are examples of the influenza complications | Day 1 to Day 7 |
| 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 |
| Insufficient data available |
|
| Do not meet inclusion criteria |
|
| Oseltamivir Group (OG) |
Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Oseltamivir Goup (OG) | Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza |
|
|
|
| Secondary | 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 | Per Protocol set. | Posted | Number | Percentage of participants | on the day 7 of the observation |
|
|
|
|
| Secondary | 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. | Per Protocol set | Posted | Mean | Standard Deviation | Days | Day 1 to Day 7 |
|
|
|
|
| Secondary | 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) | Per Protocol set | Posted | Mean | Standard Deviation | °C | on days 1, 3 and 7 of the observation |
|
|
|
|
| Secondary | 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) | Per Protocol set | Posted | Mean | Standard Deviation | Scores on a scale | on days 1, 3 and 7 of the observation |
|
|
|
|
| Secondary | The Number of the Antipyretic Intake | A subject recorded the number of antipyretic intake in patient diary. | Per Protocol set | Posted | Mean | Standard Deviation | Number of Doses | Day 1 to Day 5 |
|
|
|
|
| Secondary | 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). | Per Protocol set | Posted | Mean | Standard Deviation | Scores on a scale | Day 7 vs. Day 1 |
|
|
|
|
| Secondary | 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). | Per Protocol set | Posted | Mean | Standard Deviation | Scores on a scale | Day 7 vs. Day 1 |
|
|
|
|
| Secondary | Percentage of Patients With Complications of the Influenza | Pneumonia, sinusitis, otitis media are examples of the influenza complications | Per Protocol set | Posted | Number | Percentage of participants | Day 1 to Day 7 |
|
|
|
|
| 0 |
| 81 |
| 11 |
| 81 |
| EG001 | Oseltamivir Group | Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.). | 0 | 80 | 15 | 80 |
| Acute pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Throat burning sensation of | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abnormal feces | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urine mucous | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urine white blood cells increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Urine red blood cells increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Crystal urine | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Bacteria urine | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Specific gravity urine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Bilirubin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood monocytes increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| ESR increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Respiratory symptoms |
|
| All symptoms |
|
| Respiratory symptoms |
|
| All influenza symptoms |
|
| Axillary temperature, Day 7 |
|
| Common symptoms, Day 7 |
|
| Respiratory symptoms, Day 1 |
|
| Respiratory symptoms, Day 3 |
|
| Respiratory symptoms, Day 7 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|