Trial Outcomes & Findings for Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder. (NCT NCT03575702)
NCT ID: NCT03575702
Last Updated: 2019-05-21
Results Overview
The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
COMPLETED
PHASE3
300 participants
Baseline and Week 12
2019-05-21
Participant Flow
Subjects enrollment was conducted in 11 clinical sites in Russia between July 2016 and April 2017. After the screening period 300 patients (150 in each group) were included in the study. 299 patients started study treatments.
Participant milestones
| Measure |
Uritos®
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
150
|
|
Overall Study
COMPLETED
|
143
|
146
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Uritos®
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Patient non compliance
|
4
|
0
|
Baseline Characteristics
Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.
Baseline characteristics by cohort
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 13.50 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.54 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
146 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.7 kg/m^2
STANDARD_DEVIATION 5.48 • n=5 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 5.33 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 5.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Daily Number of Urination Episodes at Week 12
Baseline
|
12.5 urination episodes per day
Standard Deviation 3.5
|
11.9 urination episodes per day
Standard Deviation 2.7
|
|
Change in the Mean Daily Number of Urination Episodes at Week 12
Week 12 of treatment
|
9.0 urination episodes per day
Standard Deviation 3.0
|
8.6 urination episodes per day
Standard Deviation 2.5
|
|
Change in the Mean Daily Number of Urination Episodes at Week 12
Change
|
-3.6 urination episodes per day
Standard Deviation 3.0
|
-3.4 urination episodes per day
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Daily Number of Incontinence Episodes at Week 12
Baseline
|
2.5 incontinence episodes per day
Standard Deviation 2.4
|
2.4 incontinence episodes per day
Standard Deviation 2.3
|
|
Change in the Mean Daily Number of Incontinence Episodes at Week 12
Week 12 of treatment
|
0.4 incontinence episodes per day
Standard Deviation 0.9
|
0.5 incontinence episodes per day
Standard Deviation 1.2
|
|
Change in the Mean Daily Number of Incontinence Episodes at Week 12
Change
|
-2.1 incontinence episodes per day
Standard Deviation 2.2
|
-1.9 incontinence episodes per day
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Daytime Number of Incontinence Episodes at Week 12
Baseline
|
2.0 daytime incontinence episodes per day
Standard Deviation 1.9
|
1.9 daytime incontinence episodes per day
Standard Deviation 1.8
|
|
Change in the Mean Daytime Number of Incontinence Episodes at Week 12
Week 12 of treatment
|
0.4 daytime incontinence episodes per day
Standard Deviation 0.7
|
0.4 daytime incontinence episodes per day
Standard Deviation 0.9
|
|
Change in the Mean Daytime Number of Incontinence Episodes at Week 12
Change
|
-1.7 daytime incontinence episodes per day
Standard Deviation 1.7
|
-1.5 daytime incontinence episodes per day
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
Baseline
|
0.5 nighttime incontinence episode per day
Standard Deviation 0.8
|
0.5 nighttime incontinence episode per day
Standard Deviation 0.8
|
|
Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
Week 12 of treatment
|
0.1 nighttime incontinence episode per day
Standard Deviation 0.3
|
0.1 nighttime incontinence episode per day
Standard Deviation 0.4
|
|
Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
Change
|
-0.4 nighttime incontinence episode per day
Standard Deviation 0.8
|
-0.4 nighttime incontinence episode per day
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4 and 8Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
Separately for daily, daytime and nighttime measurements.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Baseline number of daily incontinence episodes
|
2.5 incontinence episodes per day
Standard Deviation 2.4
|
2.4 incontinence episodes per day
Standard Deviation 2.3
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daily incontinence episodes (week 2)
|
-1.5 incontinence episodes per day
Standard Deviation 1.8
|
-1.3 incontinence episodes per day
Standard Deviation 1.3
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daily incontinence episodes (week 4)
|
-1.8 incontinence episodes per day
Standard Deviation 2.0
|
-1.7 incontinence episodes per day
Standard Deviation 1.5
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daily incontinence episodes (week 8)
|
-2.0 incontinence episodes per day
Standard Deviation 2.0
|
-1.8 incontinence episodes per day
Standard Deviation 1.5
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Baseline number of daytime incontinence episodes
|
2.0 incontinence episodes per day
Standard Deviation 1.9
|
1.9 incontinence episodes per day
Standard Deviation 1.8
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daytime incontinence episodes (week 2)
|
-1.2 incontinence episodes per day
Standard Deviation 1.3
|
-1.0 incontinence episodes per day
Standard Deviation 1.1
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daytime incontinence episodes (week 4)
|
-1.5 incontinence episodes per day
Standard Deviation 1.5
|
-1.3 incontinence episodes per day
Standard Deviation 1.3
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in daytime incontinence episodes (week 8)
|
-1.7 incontinence episodes per day
Standard Deviation 1.5
|
-1.4 incontinence episodes per day
Standard Deviation 1.3
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Baseline number of nightime incontinence episodes
|
0.5 incontinence episodes per day
Standard Deviation 0.8
|
0.5 incontinence episodes per day
Standard Deviation 0.8
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in nighttime incontinence episodes (week 2)
|
-0.3 incontinence episodes per day
Standard Deviation 0.6
|
-0.3 incontinence episodes per day
Standard Deviation 0.5
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in nighttime incontinence episodes (week 4)
|
-0.3 incontinence episodes per day
Standard Deviation 0.8
|
-0.4 incontinence episodes per day
Standard Deviation 0.6
|
|
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Change in nighttime incontinence episodes (week 8)
|
-0.3 incontinence episodes per day
Standard Deviation 0.7
|
-0.4 incontinence episodes per day
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Weekly Number of Incontinence Episodes at Week 12
Baseline
|
17.2 incontinence episodes per week
Standard Deviation 16.8
|
16.9 incontinence episodes per week
Standard Deviation 15.7
|
|
Change in the Mean Weekly Number of Incontinence Episodes at Week 12
Week 12 of treatment
|
3.0 incontinence episodes per week
Standard Deviation 6.5
|
3.2 incontinence episodes per week
Standard Deviation 8.3
|
|
Change in the Mean Weekly Number of Incontinence Episodes at Week 12
Change
|
-14.5 incontinence episodes per week
Standard Deviation 15.3
|
-13.6 incontinence episodes per week
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4 and 8Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Baseline
|
12.5 urination episodes per day
Standard Deviation 3.5
|
11.9 urination episodes per day
Standard Deviation 2.7
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Week 2 of treatment
|
10.6 urination episodes per day
Standard Deviation 2.9
|
10.3 urination episodes per day
Standard Deviation 2.6
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Change (week 2)
|
-1.9 urination episodes per day
Standard Deviation 2.6
|
-1.6 urination episodes per day
Standard Deviation 2.1
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Week 4 of treatment
|
9.6 urination episodes per day
Standard Deviation 2.7
|
9.4 urination episodes per day
Standard Deviation 2.6
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Change (week 4)
|
-2.8 urination episodes per day
Standard Deviation 2.7
|
-2.6 urination episodes per day
Standard Deviation 2.3
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Week 8 of treatment
|
9.4 urination episodes per day
Standard Deviation 2.7
|
8.9 urination episodes per day
Standard Deviation 2.4
|
|
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
Change (week 8)
|
-3.2 urination episodes per day
Standard Deviation 2.9
|
-3.1 urination episodes per day
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 8 and 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
Overactive bladder (OAB) Awareness Tool Questionnaire (version OAB-V8, containing 8 questions) is a validated questionnaire. Patient is asked to answer 8 questions concerning typical symptoms of OAB giving answers with a scale with minimum - 0 score defined as "no bothering at all" and maximmum - 5 score defined as "a very big deal" to assess the severity of these symptoms. All answers are simply summed to make a combined final score. Male participants should add 2 points to their final score. The final scores range from 0 to 40 (for women) and 42 (for men). The score equal to 8 and more is interpreted as high probability of OAB presence, with the higher scores indicating more bothersome symptoms of OAB.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Baseline
|
24.3 scores on a scale
Standard Deviation 7.5
|
23.8 scores on a scale
Standard Deviation 7.1
|
|
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Change (week 4)
|
-10.6 scores on a scale
Standard Deviation 7.7
|
-10.8 scores on a scale
Standard Deviation 6.9
|
|
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Change (week 8)
|
-12.4 scores on a scale
Standard Deviation 8.5
|
-13.0 scores on a scale
Standard Deviation 8.0
|
|
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Change (week 12)
|
-14.2 scores on a scale
Standard Deviation 8.5
|
-14.5 scores on a scale
Standard Deviation 8.0
|
|
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Change (week 2)
|
-8.0 scores on a scale
Standard Deviation 8.2
|
-8.2 scores on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.
The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from "no problems" to "significant problem" grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented.
Outcome measures
| Measure |
Uritos®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=148 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Change in the EQ-5D-based Quality of Life at Week 12
Baseline
|
67.7 score on a scale, mm
Standard Deviation 13.9
|
66.8 score on a scale, mm
Standard Deviation 15.0
|
|
Change in the EQ-5D-based Quality of Life at Week 12
Week 12 of treatment
|
81.7 score on a scale, mm
Standard Deviation 13.4
|
79.5 score on a scale, mm
Standard Deviation 15.4
|
|
Change in the EQ-5D-based Quality of Life at Week 12
Change (week 12)
|
13.8 score on a scale, mm
Standard Deviation 15.5
|
12.5 score on a scale, mm
Standard Deviation 14.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 35 days after the end of treatmentPopulation: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs)
|
70 Participants
|
72 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 35 days after the end of treatmentPopulation: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Number of Patients With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 4, 8 and 12Population: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Measured via the urine bladder ultrasound (US)
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Changes in the Volume of Residual Urine
Baseline
|
10.0 ml
Standard Deviation 10.2
|
10.6 ml
Standard Deviation 11.3
|
|
Changes in the Volume of Residual Urine
Change week 4 of treatment
|
-0.9 ml
Standard Deviation 10.9
|
-1.3 ml
Standard Deviation 10.8
|
|
Changes in the Volume of Residual Urine
Change week 8 of treatment
|
-1.4 ml
Standard Deviation 12.7
|
-2.2 ml
Standard Deviation 12.5
|
|
Changes in the Volume of Residual Urine
Change week 12 of treatment
|
-1.5 ml
Standard Deviation 12.6
|
-2.0 ml
Standard Deviation 13.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 8 and 12Population: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Including blood chemistry, blood count and urinalysis
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Number of Patients With Clinically Significant Changes in Laboratory Parameters
Week 8 of treatment
|
2 Participants
|
1 Participants
|
|
Number of Patients With Clinically Significant Changes in Laboratory Parameters
Week 12 of treatment
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 of treatmentPopulation: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Number of Patients With Clinically Significant Changes in ECG Parameters
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 of treatmentPopulation: Safety Population - All randomized patients taken at least one dose of investigational/reference drug
Outcome measures
| Measure |
Uritos®
n=149 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 Participants
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Number of Patients With Clinically Significant Vital Signs Changes
|
0 Participants
|
0 Participants
|
Adverse Events
Uritos®
Urotol®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Uritos®
n=149 participants at risk
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Uritos®: film-coated tablets 0.1 mg
|
Urotol®
n=150 participants at risk
one tablet orally twice a day (after breakfast and dinner) for 12 weeks
Urotol®: film coated tablets, 2 mg
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
26.8%
40/149 • Number of events 56 • Up to 35 days after the end of treatment
|
30.0%
45/150 • Number of events 55 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
8.7%
13/149 • Number of events 15 • Up to 35 days after the end of treatment
|
11.3%
17/150 • Number of events 21 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
3/149 • Number of events 3 • Up to 35 days after the end of treatment
|
4.7%
7/150 • Number of events 9 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
3.4%
5/149 • Number of events 6 • Up to 35 days after the end of treatment
|
2.7%
4/150 • Number of events 6 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
5/149 • Number of events 6 • Up to 35 days after the end of treatment
|
2.7%
4/150 • Number of events 4 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
3/149 • Number of events 5 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 4 • Up to 35 days after the end of treatment
|
|
Nervous system disorders
Headache
|
7.4%
11/149 • Number of events 15 • Up to 35 days after the end of treatment
|
11.3%
17/150 • Number of events 18 • Up to 35 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
3.4%
5/149 • Number of events 6 • Up to 35 days after the end of treatment
|
5.3%
8/150 • Number of events 10 • Up to 35 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
|
Nervous system disorders
Somnolence
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Infections and infestations
Respiratory tract infection viral
|
5.4%
8/149 • Number of events 8 • Up to 35 days after the end of treatment
|
7.3%
11/150 • Number of events 11 • Up to 35 days after the end of treatment
|
|
General disorders
Asthenia
|
0.67%
1/149 • Number of events 1 • Up to 35 days after the end of treatment
|
2.0%
3/150 • Number of events 3 • Up to 35 days after the end of treatment
|
|
General disorders
Thirst
|
1.3%
2/149 • Number of events 4 • Up to 35 days after the end of treatment
|
0.67%
1/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
General disorders
Malaise
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
|
Eye disorders
Dry eye
|
2.7%
4/149 • Number of events 4 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Eye disorders
Vision blurred
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
|
Renal and urinary disorders
Dysuria
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
2.7%
4/150 • Number of events 6 • Up to 35 days after the end of treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
2.0%
3/150 • Number of events 3 • Up to 35 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.67%
1/149 • Number of events 1 • Up to 35 days after the end of treatment
|
2.0%
3/150 • Number of events 3 • Up to 35 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.67%
1/150 • Number of events 1 • Up to 35 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/149 • Number of events 5 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
2.0%
3/150 • Number of events 3 • Up to 35 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/149 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.67%
1/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Vascular disorders
Hypertensive crisis
|
0.67%
1/149 • Number of events 2 • Up to 35 days after the end of treatment
|
1.3%
2/150 • Number of events 2 • Up to 35 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
2/149 • Number of events 2 • Up to 35 days after the end of treatment
|
0.00%
0/150 • Up to 35 days after the end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any study related information could be made public available only after Sponsors written permission.
- Publication restrictions are in place
Restriction type: OTHER