Trial Outcomes & Findings for Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients (NCT NCT01570829)
NCT ID: NCT01570829
Last Updated: 2021-08-26
Results Overview
Based on medical records.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
331 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-08-26
Participant Flow
Participant milestones
| Measure |
Dietressa
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
167
|
|
Overall Study
COMPLETED
|
164
|
167
|
|
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 |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 11.4 • n=164 Participants
|
42.8 years
STANDARD_DEVIATION 11.6 • n=167 Participants
|
43.2 years
STANDARD_DEVIATION 11.5 • n=331 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=164 Participants
|
139 Participants
n=167 Participants
|
277 Participants
n=331 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=164 Participants
|
28 Participants
n=167 Participants
|
54 Participants
n=331 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
164 participants
n=164 Participants
|
167 participants
n=167 Participants
|
331 participants
n=331 Participants
|
PRIMARY outcome
Timeframe: 24 weeksBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With at Least 5% Weight Loss.
|
80 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: On baseline and after 24 weeksBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Average Absolute Weight Change
Baseline
|
104.7 kilogram
Standard Deviation 11.6
|
105.3 kilogram
Standard Deviation 11.4
|
|
Average Absolute Weight Change
After 24 weeks
|
98.6 kilogram
Standard Deviation 12.7
|
101.3 kilogram
Standard Deviation 12.1
|
|
Average Absolute Weight Change
∆ between baseline and after 24 weeks
|
6.1 kilogram
Standard Deviation 5.3
|
4.0 kilogram
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: On baseline and after 24 weeksPopulation: ∆ between baseline and after 24 weeks
Based on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Average Relative Weight Change
|
5.9 percentage of weight loss from baseline
Standard Deviation 5.1
|
3.8 percentage of weight loss from baseline
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatmentBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Percentage of Patients With at Least 5% Weight Loss.
Baseline
|
0 Participants
|
0 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 4 weeks
|
11 Participants
|
5 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 8 weeks
|
29 Participants
|
19 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 12 weeks
|
49 Participants
|
32 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 16 weeks
|
59 Participants
|
42 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 20 weeks
|
73 Participants
|
49 Participants
|
|
Percentage of Patients With at Least 5% Weight Loss.
After 24 weeks
|
80 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: After 4, 8, 12, 16 and 20 weeks of treatmentBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Average Absolute Weight Change
Average absolute weight reduction after 4 weeks
|
1.8 kilogram
Standard Deviation 2.2
|
1.3 kilogram
Standard Deviation 1.8
|
|
Average Absolute Weight Change
Average absolute weight reduction after 8 weeks
|
2.9 kilogram
Standard Deviation 3.1
|
2.1 kilogram
Standard Deviation 2.6
|
|
Average Absolute Weight Change
Average absolute weight reduction after 12 weeks
|
3.8 kilogram
Standard Deviation 3.9
|
2.8 kilogram
Standard Deviation 3.2
|
|
Average Absolute Weight Change
Average absolute weight reduction after 16 weeks
|
4.7 kilogram
Standard Deviation 4.6
|
3.3 kilogram
Standard Deviation 3.7
|
|
Average Absolute Weight Change
Average absolute weight reduction after 20 weeks
|
5.5 kilogram
Standard Deviation 4.9
|
3.7 kilogram
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: After 4, 8, 12, 16 and 20 weeks of treatmentBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Average Relative Weight Change
Average relative weight reduction after 4 weeks
|
1.7 percentage of weight loss from baseline
Standard Deviation 2.1
|
1.3 percentage of weight loss from baseline
Standard Deviation 1.7
|
|
Average Relative Weight Change
Average relative weight reduction after 8 weeks
|
2.8 percentage of weight loss from baseline
Standard Deviation 2.9
|
2.0 percentage of weight loss from baseline
Standard Deviation 2.5
|
|
Average Relative Weight Change
Average relative weight reduction after 12 weeks
|
3.7 percentage of weight loss from baseline
Standard Deviation 3.7
|
2.7 percentage of weight loss from baseline
Standard Deviation 3.0
|
|
Average Relative Weight Change
Average relative weight reduction after 16 weeks
|
4.5 percentage of weight loss from baseline
Standard Deviation 4.4
|
3.2 percentage of weight loss from baseline
Standard Deviation 3.5
|
|
Average Relative Weight Change
Average relative weight reduction after 20 weeks
|
5.3 percentage of weight loss from baseline
Standard Deviation 4.8
|
3.5 percentage of weight loss from baseline
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: After 4, 12 and 24 weeks of treatmentBased on medical records.
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference after 4 weeks
|
2.2 centimeter
Standard Deviation 3.3
|
2.6 centimeter
Standard Deviation 3.5
|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference after 12 weeks
|
4.8 centimeter
Standard Deviation 5.2
|
4.7 centimeter
Standard Deviation 5.4
|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference after 24 weeks
|
6.9 centimeter
Standard Deviation 10.7
|
6.9 centimeter
Standard Deviation 6.1
|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference/hip circumference after 4 weeks
|
0.01 centimeter
Standard Deviation 0.03
|
0.01 centimeter
Standard Deviation 0.03
|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference/hip circumference after 12 weeks
|
0.01 centimeter
Standard Deviation 0.04
|
0.01 centimeter
Standard Deviation 0.05
|
|
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Change in waist circumference/hip circumference after 24 weeks
|
0.01 centimeter
Standard Deviation 0.04
|
0.01 centimeter
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: On baseline and after 4, 12, 24 weeks of treatmentBased on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline
Outcome measures
| Measure |
Dietressa
n=164 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 Participants
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
Baseline Physical Health domain
|
46.6 score on a scale
Standard Deviation 8.1
|
47.3 score on a scale
Standard Deviation 8.4
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 4 weeks Physical Health domain
|
47.7 score on a scale
Standard Deviation 7.8
|
49.0 score on a scale
Standard Deviation 8.0
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 12 weeks Physical Health domain
|
49.1 score on a scale
Standard Deviation 7.6
|
49.7 score on a scale
Standard Deviation 7.7
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 24 weeks Physical Health domain
|
49.7 score on a scale
Standard Deviation 6.8
|
50.9 score on a scale
Standard Deviation 7.1
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
Baseline Mental Health domain
|
44.7 score on a scale
Standard Deviation 10.8
|
46.3 score on a scale
Standard Deviation 9.7
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 4 weeks Mental Health domain
|
48.2 score on a scale
Standard Deviation 9.9
|
48.5 score on a scale
Standard Deviation 9.3
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 12 weeks Mental Health domain
|
48.3 score on a scale
Standard Deviation 9.4
|
49.2 score on a scale
Standard Deviation 8.9
|
|
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
After 24 weeks Mental Health domain
|
49.2 score on a scale
Standard Deviation 8.4
|
50.4 score on a scale
Standard Deviation 8.3
|
Adverse Events
Dietressa
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dietressa
n=164 participants at risk
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 participants at risk
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Renal and urinary disorders
Membranous nephropathy
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Infections and infestations
Gangrenous appendicitis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
Other adverse events
| Measure |
Dietressa
n=164 participants at risk
Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration.
|
Placebo
n=167 participants at risk
Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Stomach pain
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Infections and infestations
Viral respiratory tract infection
|
7.9%
13/164 • Number of events 13 • During the study - 24 weeks.
|
4.8%
8/167 • Number of events 8 • During the study - 24 weeks.
|
|
Infections and infestations
Nail bed infection
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Infections and infestations
Candida Infection
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Infections and infestations
Tooth pulpitis
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Infections and infestations
Chronic hepatitis C
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Abnormal glucose tolerance test results
|
0.00%
0/164 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Deviation from the ESR norm
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Increased blood pressure
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Increased ESR
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Increased ALT
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Increased AST
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Increased blood glucose
|
2.4%
4/164 • Number of events 4 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Increased lymphocytes
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Increase in LDL cholesterol
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Increased monocytes
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Increased platelets
|
0.00%
0/164 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Increased eosinophils
|
0.00%
0/164 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Increased red blood cells
|
0.00%
0/164 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Elevated LDL
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Elevated triglycerides
|
0.00%
0/164 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Investigations
Decreased serum creatinine levels
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Decreased platelets
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Investigations
Weight gain
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Investigations
Increased LDL to HDL ratio
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
1.8%
3/164 • Number of events 3 • During the study - 24 weeks.
|
1.2%
2/167 • Number of events 2 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Impaired fasting glycemia
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Type II diabetes mellitus
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.8%
3/164 • Number of events 3 • During the study - 24 weeks.
|
3.6%
6/167 • Number of events 6 • During the study - 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Blood and lymphatic system disorders
Anemia, unspecified
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Subchondral bone cyst
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Nervous system disorders
Headache
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Nervous system disorders
Migraine
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Nervous system disorders
Cranial nerve neuritis
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Nervous system disorders
Increased activity
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Eye disorders
Retinal dystrophy
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Hepatobiliary disorders
Chronic cholecystitis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Reproductive system and breast disorders
Bartholin's gland cyst
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Reproductive system and breast disorders
Menstrual disorders
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
General disorders
Asthenia
|
1.2%
2/164 • Number of events 2 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
General disorders
Thirst
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
General disorders
Increased body temperature
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
General disorders
Decreased activity
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/164 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Psychiatric disorders
Depression
|
11.0%
18/164 • Number of events 18 • During the study - 24 weeks.
|
6.0%
10/167 • Number of events 10 • During the study - 24 weeks.
|
|
Psychiatric disorders
Depression, worsening
|
7.3%
12/164 • Number of events 12 • During the study - 24 weeks.
|
7.8%
13/167 • Number of events 13 • During the study - 24 weeks.
|
|
Psychiatric disorders
Feeling of elation
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.60%
1/167 • Number of events 1 • During the study - 24 weeks.
|
|
Psychiatric disorders
Increased anxiety
|
19.5%
32/164 • Number of events 32 • During the study - 24 weeks.
|
21.6%
36/167 • Number of events 36 • During the study - 24 weeks.
|
|
Injury, poisoning and procedural complications
Bruised toe
|
0.61%
1/164 • Number of events 1 • During the study - 24 weeks.
|
0.00%
0/167 • During the study - 24 weeks.
|
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