Trial Outcomes & Findings for Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children (NCT NCT01843842)
NCT ID: NCT01843842
Last Updated: 2018-11-29
Results Overview
Based on the data mentioned in a patient's diary
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
306 participants
Primary outcome timeframe
On day 2, 3 and 4 of observation
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
Ergoferon in Liquid Dosage Form
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
152
|
|
Overall Study
COMPLETED
|
153
|
151
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ergoferon in Liquid Dosage Form
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Overall Study
Do not meet inclusion criteria
|
1
|
1
|
Baseline Characteristics
Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Baseline characteristics by cohort
| Measure |
Ergoferon in Liquid Dosage Form
n=154 Participants
1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day
|
Placebo
n=152 Participants
1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.8 years
STANDARD_DEVIATION 4.1 • n=93 Participants
|
10.2 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
10.0 years
STANDARD_DEVIATION 4.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
154 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
306 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: On day 2, 3 and 4 of observationPopulation: Per Protocol set
Based on the data mentioned in a patient's diary
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Day 2
|
9 percentage of participants
|
1 percentage of participants
|
|
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Day 3
|
21 percentage of participants
|
11 percentage of participants
|
|
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Day 4
|
44 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and days 2, 3, 4 and 5 of observationPopulation: Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries.
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=138 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=142 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Day 5, Morning
|
-1.90 °C
Standard Deviation 0.37
|
-1.86 °C
Standard Deviation 0.38
|
|
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Day 2, Morning
|
-0.96 °C
Standard Deviation 0.55
|
-0.79 °C
Standard Deviation 0.53
|
|
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Day 3, Morning
|
-1.49 °C
Standard Deviation 0.47
|
-1.30 °C
Standard Deviation 0.50
|
|
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Day 4, Morning
|
-1.77 °C
Standard Deviation 0.41
|
-1.69 °C
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: On day 2, 3, 4, 5 of observationPopulation: Per Protocol set.
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 2, Morning
|
21 percentage of participants
|
16 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 2, Evening
|
29 percentage of participants
|
22 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 3, Morning
|
68 percentage of participants
|
53 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 3, Evening
|
59 percentage of participants
|
51 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 4, Morning
|
89 percentage of participants
|
86 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 4, Evening
|
81 percentage of participants
|
78 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 5, Morning
|
98 percentage of participants
|
97 percentage of participants
|
|
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Day 5, Evening
|
94 percentage of participants
|
95 percentage of participants
|
SECONDARY outcome
Timeframe: on Days 2, 3, 4, 5 of ObservationPopulation: Per Protocol set
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Fever (Day 3, doctor's examination)
|
0.3 Score
Standard Deviation 0.5
|
0.4 Score
Standard Deviation 0.6
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Non-specific (Day 3, doctor's examination)
|
1.7 Score
Standard Deviation 1.8
|
1.9 Score
Standard Deviation 1.8
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Nasal/Throat/Chest (Day 3, doctor's examination)
|
3.6 Score
Standard Deviation 2.2
|
3.7 Score
Standard Deviation 2.1
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
All symptoms (Day 3, doctor's examination)
|
5.5 Score
Standard Deviation 3.7
|
6.0 Score
Standard Deviation 3.6
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Fever (Day 2, patient diary data)
|
0.8 Score
Standard Deviation 0.7
|
1.0 Score
Standard Deviation 0.8
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Non-specific (Day 2, patient diary data)
|
3.3 Score
Standard Deviation 3.0
|
4.1 Score
Standard Deviation 3.1
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Nasal/Throat/Chest (Day 2, patient diary data)
|
4.4 Score
Standard Deviation 2.8
|
5.0 Score
Standard Deviation 2.8
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
All symptoms (Day 2, patient diary data)
|
9.4 Score
Standard Deviation 6.1
|
11.1 Score
Standard Deviation 6.3
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Fever (Day 3, patient diary data)
|
0.3 Score
Standard Deviation 0.5
|
0.5 Score
Standard Deviation 0.6
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Non-specific (Day 3, patient diary data)
|
1.7 Score
Standard Deviation 1.9
|
1.9 Score
Standard Deviation 1.8
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Nasal/Throat/Chest (Day 3, patient diary data)
|
3.3 Score
Standard Deviation 2.2
|
3.6 Score
Standard Deviation 2.1
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
All symptoms (Day 3, patient diary data)
|
5.6 Score
Standard Deviation 4.2
|
6.4 Score
Standard Deviation 4.1
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Fever (Day 4, patient diary data)
|
0.1 Score
Standard Deviation 0.3
|
0.1 Score
Standard Deviation 0.4
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Non-specific (Day 4, patient diary data)
|
0.6 Score
Standard Deviation 1.1
|
0.8 Score
Standard Deviation 1.2
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Nasal/Throat/Chest (Day 4, patient diary data)
|
2.3 Score
Standard Deviation 2.0
|
2.3 Score
Standard Deviation 1.4
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
All symptoms (Day 4, patient diary data)
|
3.1 Score
Standard Deviation 2.9
|
3.3 Score
Standard Deviation 2.5
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Fever (Day 5, patient diary data)
|
0.0 Score
Standard Deviation 0.2
|
0.0 Score
Standard Deviation 0.2
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Non-specific (Day 5, patient diary data)
|
0.2 Score
Standard Deviation 0.8
|
0.2 Score
Standard Deviation 0.6
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
Nasal/Throat/Chest (Day 5, patient diary data)
|
1.3 Score
Standard Deviation 1.5
|
1.3 Score
Standard Deviation 1.2
|
|
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
All symptoms (Day 5, patient diary data)
|
1.6 Score
Standard Deviation 2.0
|
1.6 Score
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: baseline and days 2, 3, 4 and 5 of observationPopulation: Per Protocol set.
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Nasal/ throat/ chest symptoms
|
84.0 hours
Standard Deviation 33.2
|
88.9 hours
Standard Deviation 29.9
|
|
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Fever
|
26.7 hours
Standard Deviation 22.9
|
31.6 hours
Standard Deviation 23.9
|
|
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Non-specific symptoms
|
55.2 hours
Standard Deviation 31.0
|
60.8 hours
Standard Deviation 30.5
|
|
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
All symptoms
|
86.0 hours
Standard Deviation 30.8
|
91.1 hours
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: On days 1-6 of observationPopulation: Per Protocol set.
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Fever (Days 1, 3, 6 doctor's examination)
|
1.3 AUC score*day
Standard Deviation 0.6
|
1.5 AUC score*day
Standard Deviation 0.7
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Non-specific (Days 1, 3, 6 doctor's examination)
|
4.9 AUC score*day
Standard Deviation 3.0
|
5.2 AUC score*day
Standard Deviation 2.6
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Nasal/Throat/Chest (Days 1, 3, 6 doctor's examinat
|
6.9 AUC score*day
Standard Deviation 3.6
|
7.2 AUC score*day
Standard Deviation 3.3
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
All symptoms (Days 1, 3, 6 doctor's examination)
|
13.1 AUC score*day
Standard Deviation 5.7
|
13.9 AUC score*day
Standard Deviation 5.3
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Fever (Days 1-5, patient diary data)
|
2.1 AUC score*day
Standard Deviation 1.6
|
2.6 AUC score*day
Standard Deviation 1.7
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Non-specific (Days 1-5, patient diary data)
|
8.7 AUC score*day
Standard Deviation 6.7
|
10.1 AUC score*day
Standard Deviation 6.6
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
Nasal/Throat/Chest (Days 1-5, patient diary data)
|
13.4 AUC score*day
Standard Deviation 8.0
|
14.4 AUC score*day
Standard Deviation 7.1
|
|
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
All symptoms (Days 1-5, patient diary data)
|
26.3 AUC score*day
Standard Deviation 14.8
|
29.6 AUC score*day
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: On day 1, 2, 3, 4 and 5 of the treatmentPopulation: Per Protocol set.
Based on data mentioned in a patient's diary
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Number of Intakes of Antipyretics if Indicated
Day 1
|
0.84 Number of intakes
Standard Deviation 0.86
|
0.85 Number of intakes
Standard Deviation 0.78
|
|
Number of Intakes of Antipyretics if Indicated
Day 2
|
0.20 Number of intakes
Standard Deviation 0.57
|
0.30 Number of intakes
Standard Deviation 0.71
|
|
Number of Intakes of Antipyretics if Indicated
Day 3
|
0.08 Number of intakes
Standard Deviation 0.36
|
0.09 Number of intakes
Standard Deviation 0.40
|
|
Number of Intakes of Antipyretics if Indicated
Day 4
|
0.03 Number of intakes
Standard Deviation 0.26
|
0.03 Number of intakes
Standard Deviation 0.25
|
|
Number of Intakes of Antipyretics if Indicated
Day 5
|
0.01 Number of intakes
Standard Deviation 0.17
|
0.00 Number of intakes
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: On days 1-6 of observationPopulation: Per Protocol set.
The development of disease complications requiring antibiotics administration or hospitalization
Outcome measures
| Measure |
Ergoferon in Liquid Dosage Form
n=145 Participants
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=148 Participants
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Percentage of Patients With Exacerbation of the Disease Course
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Ergoferon in Liquid Dosage Form
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ergoferon in Liquid Dosage Form
n=154 participants at risk
Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
Placebo
n=152 participants at risk
Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear ache
|
0.65%
1/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.00%
0/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.66%
1/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.00%
0/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
|
Nervous system disorders
Dizziness
|
0.65%
1/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.00%
0/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
|
Psychiatric disorders
Disturbance of a night's sleep
|
0.00%
0/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.66%
1/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.65%
1/154 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
0.00%
0/152 • Adverse/Serious adverse events were registered from Day 1 to Day 6
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=306, Safety Population)
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials
Materia Medica Holding
Phone: +74952761575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER