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A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (LION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01565707
First received: March 27, 2012
Last updated: February 27, 2017
Last verified: February 2017
Results First Received: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Urinary Bladder, Overactive
Interventions: Drug: Solifenacin Succinate Suspension
Drug: Placebo
Behavioral: Urotherapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population consisted of male and female children (5 to 11 years old) and adolescents (12 to 17 years old) with overactive bladder (OAB).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects received 4 weeks of urotherapy (standard first line therapy for pediatric OAB patients). Two weeks after start of urotherapy a single-blind 2-week placebo run-in period began. After run-in period eligible subjects were randomized to 12 weeks of double-blind treatment (solifenacin succinate suspension or placebo) and continued urotherapy.

Reporting Groups
  Description
Placebo Children Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Children Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Placebo Adolescents Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Adolescents Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.

Participant Flow:   Overall Study
    Placebo Children   Solifenacin Succinate Suspension Children   Placebo Adolescents   Solifenacin Succinate Suspension Adolescents
STARTED   75   73   19   22 
Treated   73   73   19   22 
COMPLETED   66   65   16   17 
NOT COMPLETED   9   8   3   5 
Adverse Event                1                6                2                1 
Lost to Follow-up                1                0                0                0 
Protocol Violation                1                0                0                1 
Withdrawal by Subject                3                1                1                1 
Randomized but not evaluable                2                0                0                0 
Miscellaneous                1                1                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline values provided are based on the Safety Analysis Set (SAF) population and the Full Analysis Set (FAS). Population analysis is defined within each baseline measure.

Reporting Groups
  Description
Placebo Children Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Children Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Placebo Adolescents Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
Solifenacin Succinate Suspension Adolescents Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
Total Total of all reporting groups

Baseline Measures
   Placebo Children   Solifenacin Succinate Suspension Children   Placebo Adolescents   Solifenacin Succinate Suspension Adolescents   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   73   19   22   187 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
         
Children   7.4  (1.6)   7.6  (1.6)   NA [2]   NA [2]   7.5  (1.6) 
Adolescents   NA [2]   NA [2]   14.4  (1.9)   14.2  (1.8)   14.3  (1.8) 
[1] Age values provided are for the Safety Analysis Set (SAF) population. The SAF consisted of all participants who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug. The number of participants was 73; 73; 19; 22 per treatment arm.
[2] Category not applicable to the arm.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
         
Female      35  47.9%      44  60.3%      16  84.2%      17  77.3%      112  59.9% 
Male      38  52.1%      29  39.7%      3  15.8%      5  22.7%      75  40.1% 
[1] SAF population. The number of participants was 73; 73: 19; 22 per treatment arm.
Race [1] 
[Units: Participants]
         
White   57   62   13   16   148 
Black/African American   3   2   1   2   8 
Asian   6   5   3   4   18 
American Indian/Alaskan Native   3   4   2   0   9 
Other   4   0   0   0   4 
[1] SAF population. The number of participants was 73; 73; 19; 22 per treatment arm.
Ethnicity [1] 
[Units: Participants]
         
Hispanic or Latino   8   9   3   2   22 
Not Hispanic or Latino   65   64   16   20   165 
[1] SAF population. The number of participants was 73; 73; 19; 22 per treatment arm.
Mean Volume Voided (MVV) per Micturition [1] [2] 
[Units: mL]
Mean (Standard Deviation)
         
Children   94.06  (38.12)   96.88  (40.98)   NA [2]   NA [2]   95.50  (39.50) 
Adolescents   NA [2]   NA [2]   169.06  (63.65)   159.55  (61.21)   164.07  (61.76) 
[1] Values for this baseline characteristic are based on the Full Analysis Set (FAS). The FAS consisted of all randomized patients that took at least 1 dose of double-blind study medication after randomization and provided a valid baseline and post baseline value for the primary efficacy endpoint. A micturition is any voluntary urination, excluding episodes of incontinence only. Micturitions voided volumes were recorded in a patient diary for any 2 days in the 7 day period prior to the baseline visit (referred to as "measuring days"). The number of participants was 70; 73; 19; 21 per arm.
[2] Category not applicable to the arm.
Daytime Maximum Volume Voided (DMaxVV) Per Micturition [1] [2] 
[Units: mL]
Mean (Standard Deviation)
         
Children   141.43  (52.09)   155.51  (70.66)   NA [2]   NA [2]   148.62  (62.45) 
Adolescents   NA [2]   NA [2]   278.16  (119.21)   252.38  (108.68)   264.63  (113.08) 
[1] FAS population. The mean DMaxVV was determined using the patient diary data recorded during two measuring days (i.e., days when the patient recorded the volume of each micturition) in the 7 days prior to the baseline visit. The DMaxVV is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary (first morning void excluded). Daytime defined as time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 73; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Incontinence Episodes per 24 Hours [1] [2] 
[Units: Incontinence episodes]
Mean (Standard Deviation)
         
Children   2.98  (2.63)   2.46  (2.57)   NA [2]   NA [2]   2.71  (2.60) 
Adolescents   NA [2]   NA [2]   2.81  (2.45)   1.82  (1.66)   2.29  (2.11) 
[1] FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. An incontinence episode is defined as an episode with any involuntary loss of urine. The number of participants was 70; 73; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Daytime Incontinence Episodes per 24 Hours [1] [2] 
[Units: Daytime incontinence episodes]
Mean (Standard Deviation)
         
Children   2.54  (2.75)   1.98  (3.24)   NA [2]   NA [2]   2.26  (3.01) 
Adolescents   NA [2]   NA [2]   2.03  (2.18)   1.50  (1.44)   1.75  (1.83) 
[1] FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. Daytime is defined as the time between waking up in the morning and going to bed later the same day. An incontinence episode is defined as an episode with any involuntary loss of urine. The number of participants was 70; 71; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Nighttime Incontinence Episodes per 24 Hours [1] [2] 
[Units: Nighttime incontinence episodes]
Mean (Standard Deviation)
         
Children   0.59  (0.47)   0.70  (0.82)   NA [2]   NA [2]   0.64  (0.67) 
Adolescents   NA [2]   NA [2]   0.39  (0.66)   0.33  (0.40)   0.36  (0.53) 
[1] FAS population. The mean of the number of incontinence episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning. The number of participants was 70; 71; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Number of Dry (Incontinence-free) Days per 7 Days [1] [2] 
[Units: Dry Days]
Mean (Standard Deviation)
         
Children   0.5  (0.9)   0.9  (1.6)   NA [2]   NA [2]   0.7  (1.3) 
Adolescents   NA [2]   NA [2]   1.0  (1.0)   1.5  (1.3)   1.3  (1.2) 
[1] FAS population. The mean of the number of dry days was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was 70; 73; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Number of Dry (Incontinence-free) Nights per 7 Days [1] [2] 
[Units: Dry Nights]
Mean (Standard Deviation)
         
Children   3.4  (3.0)   3.1  (3.0)   NA [2]   NA [2]   3.2  (3.0) 
Adolescents   NA [2]   NA [2]   5.6  (2.2)   5.4  (2.2)   5.5  (2.2) 
[1] FAS population. The mean of the number of dry nights was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was 70; 73; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Micturitions per 24 Hours [1] [2] 
[Units: Micturitions]
Mean (Standard Deviation)
         
Children   8.26  (2.56)   8.27  (3.01)   NA [2]   NA [2]   8.27  (2.79) 
Adolescents   NA [2]   NA [2]   8.08  (3.82)   7.52  (2.37)   7.79  (3.11) 
[1] FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 73; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Daytime Micturitions per 24 Hours [1] [2] 
[Units: Daytime micturitions]
Mean (Standard Deviation)
         
Children   7.54  (3.14)   8.00  (3.40)   NA [2]   NA [2]   7.77  (3.27) 
Adolescents   NA [2]   NA [2]   6.79  (2.92)   6.88  (2.14)   6.84  (2.51) 
[1] FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 71; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Nighttime Micturitions per 24 Hours [1] [2] 
[Units: Nighttime micturitions]
Mean (Standard Deviation)
         
Children   0.60  (0.78)   0.56  (0.98)   NA [2]   NA [2]   0.58  (0.88) 
Adolescents   NA [2]   NA [2]   0.61  (1.09)   0.26  (0.41)   0.43  (0.81) 
[1] FAS population. The mean of the number of micturitions was determined using diary data recorded by the participant in the 7 days prior to baseline visit. A micturition is any voluntary urination, excluding episodes of incontinence only. The number of participants was 70; 71; 19; 21 per treatment arm.
[2] Category not applicable to the arm.
Mean Number of Grade 3 or 4 Urgency Episodes per 24 Hours in Adolescents [1] [2] 
[Units: Urgency episodes]
Mean (Standard Deviation)
 NA [2]   NA [2]   3.67  (4.15)   2.42  (2.13)   3.03  (3.29) 
[1] FAS population. Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using diary data recorded by the participant in the 7 days prior to baseline visit. The number of participants was N/A; N/A; 19; 20 per treatment arm.
[2] Baseline measure not applicable to the arm.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours   [ Time Frame: Baseline and week 12 ]

10.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Maximum Concentration (Cmax) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

13.  Secondary:   Time to Attain Maximum Concentration (Tmax) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

14.  Secondary:   Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

15.  Secondary:   Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

16.  Secondary:   Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

17.  Secondary:   Apparent Total Body Clearance (CL/F) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

18.  Secondary:   Apparent Volume of Distribution (Vz/F) of Solifenacin   [ Time Frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake). ]

19.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From the first dose of study drug until 7 days after last dose of study medication (13 weeks). ]

20.  Secondary:   Change From Baseline in Post Void Residual (PVR) Volume   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Medical Science - Urology
Organization: Astellas Pharma Europe B.V.
e-mail: Astellas.resultsdisclosure@astellas.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01565707     History of Changes
Other Study ID Numbers: 905-CL-076
2011-002066-20 ( EudraCT Number )
Study First Received: March 27, 2012
Results First Received: December 5, 2016
Last Updated: February 27, 2017