Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children (NCT NCT04569357)
NCT ID: NCT04569357
Last Updated: 2024-08-01
Results Overview
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-V). The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). Home version will evaluate behaviour and emotional response in the situations in which the child is with his/her parents. ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
363 participants
Primary outcome timeframe
After 8 weeks of treatment
Results posted on
2024-08-01
Participant Flow
Participant milestones
| Measure |
Prospekta
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
189
|
|
Overall Study
COMPLETED
|
174
|
189
|
|
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 |
Prospekta
n=174 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
174 Participants
n=174 Participants
|
189 Participants
n=189 Participants
|
363 Participants
n=363 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=174 Participants
|
0 Participants
n=189 Participants
|
0 Participants
n=363 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=174 Participants
|
0 Participants
n=189 Participants
|
0 Participants
n=363 Participants
|
|
Age, Continuous
|
9.3 years
STANDARD_DEVIATION 1.7 • n=174 Participants
|
9.3 years
STANDARD_DEVIATION 1.7 • n=189 Participants
|
9.3 years
STANDARD_DEVIATION 1.7 • n=363 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=174 Participants
|
66 Participants
n=189 Participants
|
130 Participants
n=363 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=174 Participants
|
123 Participants
n=189 Participants
|
233 Participants
n=363 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
174 participants
n=174 Participants
|
189 participants
n=189 Participants
|
363 participants
n=363 Participants
|
PRIMARY outcome
Timeframe: After 8 weeks of treatmentPopulation: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-V). The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). Home version will evaluate behaviour and emotional response in the situations in which the child is with his/her parents. ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home).
Outcome measures
| Measure |
Prospekta
n=170 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=187 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Total ADHD-RS-V Reduction ≥25%
|
95 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentPopulation: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V will evaluate 18 symptoms presented as brief characteristics of peculiarities in behaviour and emotional response of children in various situations (at home, with his/her parents). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for scale is to be formed using summations of all items. The maximum possible number of points is 54. The minimum score is 0. Higher score = more severe ADHD symptoms.
Outcome measures
| Measure |
Prospekta
n=170 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=187 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
Baseline
|
32.5 score on a scale
Standard Deviation 6.0
|
32.7 score on a scale
Standard Deviation 6.3
|
|
Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
After 4 weeks of treatment
|
27.6 score on a scale
Standard Deviation 6.2
|
28.2 score on a scale
Standard Deviation 6.4
|
|
Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
After 8 weeks of treatment
|
22.3 score on a scale
Standard Deviation 7.4
|
24.6 score on a scale
Standard Deviation 8.7
|
|
Change in Total Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) Score
∆ between baseline and after 8 weeks of treatment
|
10.2 score on a scale
Standard Deviation 7.7
|
8.1 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentPopulation: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Attention deficit subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity/impulsivity. The attention deficit items are: (1) Attention to detail; (2) Sustaining attention; (3) Does not seem to listen; (4) Follows instructions; (5) Difficulty organizing; (6) Sustained mental effort; (7) Loses things; (8) Distracted; (9) Forgetful. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for attention deficit subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.
Outcome measures
| Measure |
Prospekta
n=170 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=187 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Total ADHD-RS-V Attention Deficit Subscale Score
Baseline
|
18.4 score on a scale
Standard Deviation 3.3
|
18.3 score on a scale
Standard Deviation 3.5
|
|
Change in Total ADHD-RS-V Attention Deficit Subscale Score
After 4 weeks of the treatment
|
15.7 score on a scale
Standard Deviation 3.7
|
15.7 score on a scale
Standard Deviation 3.7
|
|
Change in Total ADHD-RS-V Attention Deficit Subscale Score
After 8 weeks of the treatment
|
13.0 score on a scale
Standard Deviation 4.0
|
14.0 score on a scale
Standard Deviation 4.7
|
|
Change in Total ADHD-RS-V Attention Deficit Subscale Score
∆ between baseline and after 8 weeks of treatment
|
5.4 score on a scale
Standard Deviation 4.3
|
4.3 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentPopulation: There is no data on the ADHD-RS-V questionnaire after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V). Hyperactivity/impulsivity subscale. Versus baseline. The home version of ADHD-RS-V will be used separately for children (7-10 years old) and teenagers (11-12 years old). The home version of ADHD-RS-V includes two subscales, one for attention deficit and one for hyperactivity-impulsivity. The hyperactivity/impulsivity items are: (1) Fidgets; (2) Leaves seat; (3) Runs about; (4) Playing quietly; (5) On the go; (6) Talks excessively; (7) Blurts out answers; (8) Awaiting turns; (9) Interrupts or intrudes. Each item is responded to using a four-point Likert scale, where 0 - "never or rarely"; 1 - "sometimes"; 2 - "often"; 3 - "very often." Total score for hyperactivity/impulsivity subscale is to be formed using summations of all items. The maximum possible number of points is 27. The minimum score is 0. Higher score = more severe ADHD symptoms.
Outcome measures
| Measure |
Prospekta
n=170 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=187 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
Baseline
|
14.1 score on a scale
Standard Deviation 4.2
|
14.4 score on a scale
Standard Deviation 4.4
|
|
Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
After 4 weeks of the treatment
|
11.9 score on a scale
Standard Deviation 4.0
|
12.5 score on a scale
Standard Deviation 4.1
|
|
Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
After 8 weeks of the treatment
|
9.3 score on a scale
Standard Deviation 4.3
|
10.5 score on a scale
Standard Deviation 4.9
|
|
Change in Total ADHD-RS-V Hyperactivity/Impulsivity Subscale Score
∆ between baseline and after 8 weeks of treatment
|
4.8 score on a scale
Standard Deviation 4.2
|
3.9 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentPopulation: There is no data on the CGI-EI scale after 8 weeks of treatment from 4 patients in the Prospekta group and 2 patients in the Placebo group.
Clinical Global Impression Efficacy Index (CGI-EI). Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result. CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines.
Outcome measures
| Measure |
Prospekta
n=170 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=187 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
CGI-EI Efficacy Score
Therapeutic effect
|
5.9 score on a scale
Standard Deviation 3.2
|
6.9 score on a scale
Standard Deviation 3.1
|
|
CGI-EI Efficacy Score
Side effect
|
1.0 score on a scale
Standard Deviation 0.2
|
1.1 score on a scale
Standard Deviation 0.3
|
|
CGI-EI Efficacy Score
Efficacy index
|
6.9 score on a scale
Standard Deviation 3.2
|
8.0 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)Based on medical records. Vital signs will be measured in a medical setting.
Outcome measures
| Measure |
Prospekta
n=174 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs (Pulse Rate (Heart Rate))
Visit 1
|
82.9 beats/min
Standard Deviation 9.2
|
82.4 beats/min
Standard Deviation 9.5
|
|
Changes in Vital Signs (Pulse Rate (Heart Rate))
Visit 2
|
83.1 beats/min
Standard Deviation 8.2
|
82.3 beats/min
Standard Deviation 8.3
|
|
Changes in Vital Signs (Pulse Rate (Heart Rate))
Visit 3
|
81.9 beats/min
Standard Deviation 8.8
|
82.4 beats/min
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)Based on medical records. Vital signs will be measured in a medical setting.
Outcome measures
| Measure |
Prospekta
n=174 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs (Blood Pressure)
Systolic pressure/Visit 1
|
104.5 mmHg
Standard Deviation 9.1
|
104.0 mmHg
Standard Deviation 9.3
|
|
Changes in Vital Signs (Blood Pressure)
Systolic pressure/Visit 2
|
104.0 mmHg
Standard Deviation 9.0
|
103.8 mmHg
Standard Deviation 9.3
|
|
Changes in Vital Signs (Blood Pressure)
Systolic pressure/Visit 3
|
104.1 mmHg
Standard Deviation 9.4
|
104.1 mmHg
Standard Deviation 9.3
|
|
Changes in Vital Signs (Blood Pressure)
Diastolic pressure/Visit 1
|
66.9 mmHg
Standard Deviation 6.5
|
66.3 mmHg
Standard Deviation 6.3
|
|
Changes in Vital Signs (Blood Pressure)
Diastolic pressure/Visit 2
|
66.8 mmHg
Standard Deviation 6.3
|
66.7 mmHg
Standard Deviation 6.9
|
|
Changes in Vital Signs (Blood Pressure)
Diastolic pressure/Visit 3
|
66.6 mmHg
Standard Deviation 5.9
|
67.0 mmHg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 2 (4 weeks), Visit 3 (8 weeks)Based on medical records. Vital signs will be measured in a medical setting.
Outcome measures
| Measure |
Prospekta
n=174 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
Visit 1
|
19.9 breaths per minute
Standard Deviation 2.5
|
20.3 breaths per minute
Standard Deviation 2.8
|
|
Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
Visit 2
|
20.0 breaths per minute
Standard Deviation 2.6
|
20.2 breaths per minute
Standard Deviation 2.9
|
|
Changes in Vital Signs (Respiration Rate (Breaths Per Minute))
Visit 3
|
20.1 breaths per minute
Standard Deviation 3.0
|
20.0 breaths per minute
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: For 8 weeks of the treatmentLaboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory.
Outcome measures
| Measure |
Prospekta
n=174 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 Participants
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With Clinically Relevant Laboratory Abnormalities
|
7 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For 8 weeks of the treatmentPopulation: Total number of AE was 66 among 46 participants. 31 AE in 23 participants of Prospekta group, 35 AE in 23 participants of Placebo group.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Outcome measures
| Measure |
Prospekta
n=31 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=35 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.
Light
|
19 Number of AE
|
19 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.
Medium
|
12 Number of AE
|
16 Number of AE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For 8 weeks of the treatmentPopulation: A total of 66 AEs were identified in 46 patients, including 31 AEs in 23 patients in the Prospekta group, 35 AEs in 23 participants of Placebo group.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Outcome measures
| Measure |
Prospekta
n=31 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=35 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
No connection
|
19 Number of AE
|
19 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
Can't be classified
|
0 Number of AE
|
3 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
Conditional
|
3 Number of AE
|
4 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
Dubious
|
2 Number of AE
|
4 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Relation to the Study Drug.
Possible
|
7 Number of AE
|
5 Number of AE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For 8 weeks of the treatmentPopulation: A total of 66 AEs were identified in 46 patients, including 31 AEs in 23 patients in the Prospekta group, 35 AEs in 23 participants of Placebo group.
Based on medical records. AE recording is started after the first dose of the study drug (SD) and continued throughout the study therapy as well as for 24 hours after the last dose of the SD.
Outcome measures
| Measure |
Prospekta
n=31 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=35 Number of AE
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
Recovery/resolution
|
25 Number of AE
|
20 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
Recovery/resolution with consequences
|
1 Number of AE
|
0 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
No recovery/resolution
|
3 Number of AE
|
13 Number of AE
|
|
Occurrence and Type of Adverse Events (AE) During the Treatment. AE Outcome.
Outcome unknown
|
2 Number of AE
|
2 Number of AE
|
Adverse Events
Prospekta
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prospekta
n=174 participants at risk
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Prospekta: Oral administration.
|
Placebo
n=189 participants at risk
One tablet per intake 2 times a day (approximately at the same time), outside of meal (between meals or 15 minutes prior to meal or drinking). The tablet should be held in mouth until completely dissolved.
Placebo: Oral administration.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Plaque on the tongue
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
1.6%
3/189 • Number of events 3 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Viral infection of the respiratory tract
|
1.1%
2/174 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
3.2%
6/189 • Number of events 6 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Flu
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
1.1%
2/189 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Acute respiratory tract infection
|
1.1%
2/174 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Acute nasopharyngitis
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Infections and infestations
Rhinitis
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Increase of white blood cells in the urine
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Total cholesterol increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
AST increase
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Creatinine increase
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Creatinine increase in the blood
|
1.1%
2/174 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Oxalate increase in urine
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Cholesterol Increase in the blood
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
White blood cells increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Neutrophils increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Shift of the leukocyte formula to the left
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
White blood cells decrease
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Percentage of lymphocytes increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Percentage of monocytes increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Percentage of stab neutrophils increase
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Investigations
Percentage of lymphocytes decrease
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis exacerbation
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Skin and subcutaneous tissue disorders
Sweating rash
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
1.1%
2/189 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Headache
|
1.1%
2/174 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
1.6%
3/189 • Number of events 3 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
1.1%
2/189 • Number of events 2 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Episodic headache
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
General disorders
Exacerbation of the present disease
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
General disorders
General weakness
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Psychiatric disorders
Urinary incontinence in sleep
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Psychiatric disorders
Obsessive-compulsive symptom
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Psychiatric disorders
Problems falling asleep
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Nervous system disorders
Ticosis disorder, unspecified
|
0.57%
1/174 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.00%
0/189 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
|
Psychiatric disorders
Enuresis exacerbation
|
0.00%
0/174 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks and within 24 hours after the last dose of the study drug).
|
0.53%
1/189 • Number of events 1 • During 8 weeks (start after taking the first dose of the study drug, during the entire period of the study therapy - 8 weeks 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