Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection (NCT NCT04244084)
NCT ID: NCT04244084
Last Updated: 2022-05-17
Results Overview
Outcome Measure is evaluated on the basis of the "ARVI severity scale" to calculate total symptom score (TSS) in patients with confirmed virus by Polymerase chain reaction (PCR). ARVI's resolution criteria: temperature ≤37.3°С + TSS ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
14 days of observation.
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
MMH-407
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
122
|
|
Overall Study
COMPLETED
|
118
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 12.6 • n=118 Participants
|
38.5 years
STANDARD_DEVIATION 11.6 • n=122 Participants
|
38.5 years
STANDARD_DEVIATION 12.1 • n=240 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=118 Participants
|
68 Participants
n=122 Participants
|
147 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=118 Participants
|
54 Participants
n=122 Participants
|
93 Participants
n=240 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
118 participants
n=118 Participants
|
122 participants
n=122 Participants
|
240 participants
n=240 Participants
|
PRIMARY outcome
Timeframe: 14 days of observation.Outcome Measure is evaluated on the basis of the "ARVI severity scale" to calculate total symptom score (TSS) in patients with confirmed virus by Polymerase chain reaction (PCR). ARVI's resolution criteria: temperature ≤37.3°С + TSS ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Outcome measures
| Measure |
MMH-407
n=78 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=73 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
|
4.1 days
Standard Deviation 1.9
|
5.0 days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: On days 1- 6 of the observation.Outcome Measure is based on the area under the curve (AUC) for TSS. AUC was calculated between 6 points (by TSS for every 6 days of the treatment and observation). The minimum value for the AUC was "0" and the maximum value was "234" units (day\*score). Higher TSS and AUC scores meant worse results.
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)
|
48.5 day*score
Standard Deviation 21.7
|
52.6 day*score
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: On days 3, 4, 5 and 6 of observation.ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Day 3
|
15 Participants
|
8 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Day 4
|
44 Participants
|
38 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Day 5
|
74 Participants
|
70 Participants
|
|
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Day 6
|
86 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 14 days of observation.Acute Respiratory Viral Infection (ARVI) Symptoms resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)
|
4.4 days
Standard Deviation 2.2
|
4.8 days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: On days 3, 4, 5 and 6 of observation.Outcome Measure is based on the Percentage of Patients With Resolution of Acute Respiratory Viral Infection, confirmed by Polymerase chain reaction (PCR), i.e virus detection. Acute Respiratory Viral Infection resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Outcome measures
| Measure |
MMH-407
n=78 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=73 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Day 3
|
12 Participants
|
3 Participants
|
|
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Day 4
|
28 Participants
|
22 Participants
|
|
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Day 5
|
54 Participants
|
38 Participants
|
|
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Day 6
|
60 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: On days 1, 2, 3 of therapy.Outcome Measure is based on the rates of antipyretic use per patient during days 1 to 3 of therapy.
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Dosing Frequency of Antipyretics.
Day 1
|
0.30 number of doses
Standard Deviation 0.68
|
0.38 number of doses
Standard Deviation 0.67
|
|
Dosing Frequency of Antipyretics.
Day 2
|
0.19 number of doses
Standard Deviation 0.48
|
0.24 number of doses
Standard Deviation 0.53
|
|
Dosing Frequency of Antipyretics.
Day 3
|
0.03 number of doses
Standard Deviation 0.22
|
0.04 number of doses
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: From day 4 to day 14 of the observation period.Outcome Measure is based on the rates of Complications that require the use of antibiotics or hospitalization.
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients Reporting Worsening of Illness
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From day 1 to day 7 of the treatment period.Severity of AEs, its causal relationship to the study drug, and outcomes.
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Occurrence and Characteristics of Adverse Events (AEs)
Mild severity
|
9 Number of events
|
11 Number of events
|
|
Occurrence and Characteristics of Adverse Events (AEs)
Number of AE
|
9 Number of events
|
11 Number of events
|
|
Occurrence and Characteristics of Adverse Events (AEs)
No relationship with the study drug
|
8 Number of events
|
11 Number of events
|
|
Occurrence and Characteristics of Adverse Events (AEs)
Probable relationship to study drug
|
1 Number of events
|
0 Number of events
|
SECONDARY outcome
Timeframe: On days 1, 5 and 7 of the treatment period.Outcome Measure is based on the medical records. Blood Pressure was measured by the physician in every visit (on days 1, 5, and 7).
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs: Blood Pressure.
Systolic blood pressure/Visit 1
|
121.0 mmHg
Standard Deviation 10.0
|
121.0 mmHg
Standard Deviation 10.1
|
|
Changes in Vital Signs: Blood Pressure.
Systolic blood pressure/Visit 2
|
120.0 mmHg
Standard Deviation 8.5
|
120.0 mmHg
Standard Deviation 8.4
|
|
Changes in Vital Signs: Blood Pressure.
Systolic blood pressure/Visit 3
|
120.0 mmHg
Standard Deviation 8.2
|
119.0 mmHg
Standard Deviation 9.4
|
|
Changes in Vital Signs: Blood Pressure.
Diastolic blood pressure/Visit 1
|
75.0 mmHg
Standard Deviation 7.5
|
75.1 mmHg
Standard Deviation 7.3
|
|
Changes in Vital Signs: Blood Pressure.
Diastolic blood pressure/Visit 2
|
74.9 mmHg
Standard Deviation 6.3
|
74.8 mmHg
Standard Deviation 6.4
|
|
Changes in Vital Signs: Blood Pressure.
Diastolic blood pressure/Visit 3
|
74.6 mmHg
Standard Deviation 6.6
|
74.8 mmHg
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: On days 1, 5 and 7 of the treatment period.Outcome Measure is based on the medical records. Pulse Rate (Heart Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs: Pulse Rate (Heart Rate).
Heart rate/Visit 1
|
86.9 bpm
Standard Deviation 12.9
|
88.0 bpm
Standard Deviation 13.0
|
|
Changes in Vital Signs: Pulse Rate (Heart Rate).
Heart rate/Visit 2
|
73.5 bpm
Standard Deviation 7.4
|
74.4 bpm
Standard Deviation 9.0
|
|
Changes in Vital Signs: Pulse Rate (Heart Rate).
Heart rate/Visit 3
|
71.1 bpm
Standard Deviation 5.8
|
71.7 bpm
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: On days 1, 5 and 7 of the treatment period.Outcome Measure is based on the medical records. Respiration Rate (Breathing Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs: Respiration Rate (Breathing Rate).
Breathing rate/Visit 1
|
17.4 breaths/min
Standard Deviation 1.6
|
17.5 breaths/min
Standard Deviation 1.6
|
|
Changes in Vital Signs: Respiration Rate (Breathing Rate).
Breathing rate/Visit 2
|
16.6 breaths/min
Standard Deviation 1.4
|
16.7 breaths/min
Standard Deviation 1.4
|
|
Changes in Vital Signs: Respiration Rate (Breathing Rate).
Breathing rate/Visit 3
|
16.4 breaths/min
Standard Deviation 1.3
|
16.4 breaths/min
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: From day 1 to day 7 of the treatment period.Outcome Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which were beyond the reference values at the end of treatment.
Outcome measures
| Measure |
MMH-407
n=118 Participants
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=122 Participants
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Clinically Relevant Laboratory Abnormalities
|
0 Participants
|
1 Participants
|
Adverse Events
MMH-407
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MMH-407
n=118 participants at risk
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=118 participants at risk；n=122 participants at risk
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Infections and infestations
Community-acquired pneumonia
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.82%
1/122 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
Other adverse events
| Measure |
MMH-407
n=118 participants at risk
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day.
Days 2 to 5: 1 tablet 3 times daily. The product must not be taken with food, but in between meals or 15-30 minutes before meal; each tablet must be held in the mouth to let it dissolve completely before it can be swallowed.
MMH-407: Oral administration.
|
Placebo
n=118 participants at risk；n=122 participants at risk
According to the scheme of receiving MMN-407 until the end of the study.
Placebo: Oral administration.
|
|---|---|---|
|
Gastrointestinal disorders
Epigastric pain
|
1.7%
2/118 • Number of events 2 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Dry mouth
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Purulent bronchitis
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Acute nasopharyngitis
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Acute tubootitis
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Herpes simplex
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Investigations
Increase in the percentage of basophils
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Investigations
Increase in the percentage of eosinophils
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of bronchial asthma
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Migraine
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
General disorders
Edema of the lips and face
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
|
General disorders
Worsening of the disease
|
0.00%
0/118 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
0.85%
1/118 • Number of events 1 • During 6 days (start after taking the first dose of the study drug, during the entire period of the study therapy - 5 days and within 24 hours after the last dose of the study drug).
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
MATERIA MEDICA HOLDING
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place