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A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565694
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neurogenic Detrusor Overactivity
Intervention Drug: Solifenacin succinate
Enrollment 76
Recruitment Details The study population consisted of male and female participants with neurogenic detrusor overactivity (NDO) aged 5 years to < 18 years old.
Pre-assignment Details After screening and a 14-day washout period, participants were treated with sequential doses of solifenacin oral suspension for 12 weeks (titration period) to determine each participant's optimal dose, after which a fixed dose of solifenacin oral suspension was given for at least 40 weeks (fixed dose assessment period).
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during dose-titration period. After completing dose titration period, participants entered fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Period Title: Dose-Titration Period
Started 76
Completed 62
Not Completed 14
Reason Not Completed
Adverse Event             4
Protocol Violation             10
Period Title: Fixed-Dose Assessment Period
Started 62
Completed 58
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify optimal dose during the dose-titration period. After the dose titration period participants entered the fixed-dose period and received a fixed dose of solifenacin once a day orally for 40 weeks or until the end of study visit (Week 52).
Overall Number of Baseline Participants 76
Hide Baseline Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants
10.8  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
Female
39
  51.3%
Male
37
  48.7%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
Hispanic or Latino
11
  14.5%
Not Hispanic or Latino
65
  85.5%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
White
45
  59.2%
Black/African American
2
   2.6%
Asian
23
  30.3%
American Indian/Alaskan Native
1
   1.3%
Other
5
   6.6%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 76 participants
38.1  (15.5)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 76 participants
138  (16.3)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  (kg/m^2)
Number Analyzed 76 participants
19.2  (4.69)
Duration of Neurogenic Detrusor Overactivity (NDO) Disease  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 76 participants
8.24
(0.4 to 16.2)
1.Primary Outcome
Title Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
Hide Description During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 49 participants
57.2  (107.7)
Change from Baseline Week 24 (LOCF) Number Analyzed 55 participants
59.3  (107.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
Hide Description During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.
Time Frame Baseline, Week 9 or Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. The number of participant analyzed represents participants with a non-missing change from baseline to last possible titration step.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mL
57.4  (105.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments [Not Specified]
Type of Statistical Test Other
Comments P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Bladder Compliance
Hide Description Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mL/cmH2O
Change from Baseline Week 24 Number Analyzed 50 participants
9.1  (28.6)
Change from Baseline Week 24 (LOCF) Number Analyzed 53 participants
8.8  (27.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Hide Description Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: Percentage of EBC
23.10
(-117.2 to 114.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Hide Description Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 30 cmH20 detrusor pressure were included in the analysis.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 17 participants
61.8  (80.6)
Change from Baseline Week 24 (LOCF) Number Analyzed 21 participants
71.9  (88.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Hide Description Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 40 cmH20 detrusor pressure were included in the analysis.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 10 participants
67.0  (44.3)
Change from Baseline Week 24 (LOCF) Number Analyzed 12 participants
54.4  (52.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
Hide Description Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Detrusor Contractions
Change from Baseline Week 24 Number Analyzed 50 participants
-2.3  (5.1)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
-1.8  (6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Detrusor Pressure at the End of Bladder Filling
Hide Description The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: cmH2O
Change from Baseline Week 24 Number Analyzed 46 participants
-9.2  (33.6)
Change from Baseline Week 24 (LOCF) Number Analyzed 51 participants
-8.2  (32.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Average Catheterized Volume Per Catheterization
Hide Description The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 51 participants
46.23  (48.32)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
48.86  (50.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Maximum Catheterized Volume
Hide Description The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 51 participants
67.45  (88.07)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
69.63  (88.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Average First Morning Catheterized Volume
Hide Description The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline Week 24 Number Analyzed 51 participants
43.24  (72.78)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
44.21  (73.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Hide Description The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Change from Baseline Week 24 Number Analyzed 51 participants
-1.60  (2.04)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
-1.62  (2.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
Hide Description The number of incontinence-free days was calculated from the 7-day micturition diary.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Days
Change from Baseline Week 24 Number Analyzed 51 participants
1.06  (2.83)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
1.19  (2.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
Hide Description The number of incontinence-free nights was calculated from the 7-day micturition diary.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Nights
Change from Baseline Week 24 Number Analyzed 51 participants
1.60  (3.08)
Change from Baseline Week 24 (LOCF) Number Analyzed 54 participants
1.64  (3.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
Hide Description Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Change from Baseline Week 24 Number Analyzed 53 participants
-0.7  (8.3)
Change from Baseline Week 24 (LOCF) Number Analyzed 51 participants
-0.7  (8.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.568
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin Succinate
Comments Analysis of change from baseline to Week 24 LOCF.
Type of Statistical Test Other
Comments P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.
Statistical Test of Hypothesis P-Value 0.573
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.
Time Frame Baseline to End of Study Visit (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description:
Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Overall Number of Participants Analyzed 76
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
51
  67.1%
Drug related TEAE
15
  19.7%
Deaths
0
   0.0%
Serious TEAEs
7
   9.2%
Drug related Serious TEAEs
0
   0.0%
TEAEs Leading to Discontinuation
4
   5.3%
Drug related TEAEs Leading to Discontinuation
3
   3.9%
Time Frame From the first dose of study drug to the last dose of study drug (up to week 52).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solifenacin Succinate
Hide Arm/Group Description Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
All-Cause Mortality
Solifenacin Succinate
Affected / at Risk (%)
Total   0/76 (0.00%)    
Hide Serious Adverse Events
Solifenacin Succinate
Affected / at Risk (%) # Events
Total   7/76 (9.21%)    
Cardiac disorders   
Tachycardia  1  1/76 (1.32%)  1
Gastrointestinal disorders   
Megacolon  1  1/76 (1.32%)  2
Infections and infestations   
Dengue fever  1  1/76 (1.32%)  1
Orchitis  1  1/76 (1.32%)  1
Urinary tract infection bacterial  1  1/76 (1.32%)  1
Nervous system disorders   
Tethered cord syndrome  1  1/76 (1.32%)  1
Surgical and medical procedures   
Spinal cord operation  1  1/76 (1.32%)  1
Vascular disorders   
Hypertension  1  1/76 (1.32%)  1
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Solifenacin Succinate
Affected / at Risk (%) # Events
Total   42/76 (55.26%)    
Gastrointestinal disorders   
Constipation  1  6/76 (7.89%)  10
Infections and infestations   
Escherichia urinary tract infection  1  6/76 (7.89%)  7
Nasopharyngitis  1  4/76 (5.26%)  5
Upper respiratory tract infection  1  4/76 (5.26%)  6
Urinary tract infection  1  12/76 (15.79%)  12
Urinary tract infection bacterial  1  14/76 (18.42%)  17
Investigations   
Electrocardiogram QT prolonged  1  4/76 (5.26%)  4
Nervous system disorders   
Headache  1  4/76 (5.26%)  4
Renal and urinary disorders   
Bladder pain  1  4/76 (5.26%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/76 (5.26%)  4
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  4/76 (5.26%)  4
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to submit all manuscripts or abstracts to the Sponsor at least 1 month prior to the submission of any such information to an editorial board or scientific review committee. This allows the Sponsor to protect proprietary information and to provide comments based on information from other studies that may not yet be available to the investigator.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Europe B.V.
Phone: 310715455050
EMail: astellas.resultsdisclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01565694    
Other Study ID Numbers: 905-CL-047
2011-000330-11 ( EudraCT Number )
First Submitted: March 27, 2012
First Posted: March 29, 2012
Results First Submitted: April 10, 2019
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019