Back to resultsA 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)
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Solifenacin Succinate Suspension
Placebo
Urotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Pediatric, Solifenacin succinate suspension, Phase 3, Pharmacokinetics, Overactive bladder (OAB)
Eligibility Criteria
Main Inclusion Criteria:
- Written Informed Consent has been obtained
- OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
- Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary
Main Exclusion Criteria:
- Daily voiding frequency less than 5
- Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
- Uroflow indicative of pathology other than OAB
- Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
- Post Void Residual (PVR) > 20 ml
- Monosymptomatic enuresis
- Polyuria defined as > 75 ml/kg/b.w./24 hours
- Dysfunctional voiding
- Congenital anomalies affecting lower urinary tract function
- Current constipation
- Current Urinary Tract Infection (UTI)
- Catheterization within 2 weeks prior to screening
Sites / Locations
- Site: 1006
- Site: 1015
- Site: 3202
- Site: 3209
- Site: 3208
- Site: 3201
- Site: 3203
- Site: 3204
- Site: 3205
- Site: 5507
- Site: 5506
- Site: 1005
- Site: 1001
- Site: 4503
- Site: 4501
- Site: 4504
- Site: 4502
- Site: 3810
- Site: 3812
- Site:8203
- Site: 8206
- Site: 8207
- Site: 8201
- Site:8202
- Site: 5202
- Site: 5205
- Site: 4701
- Site: 4702
- Site: 6301
- Site: 4805
- Site: 4803
- Site: 4804
- Site: 4801
- Site: 2703
- Site: 4606
- Site: 4601
- Site: 4603
- Site: 4602
- Site: 4605
- Site: 9001
- Site: 9002
- Site: 3853
- Site: 3854
- Site: 3850
- Site: 4403
- Site: 4401
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Placebo Children
Solifenacin Succinate Suspension Children
Placebo Adolescents
Solifenacin Succinate Suspension Adolescents
Arm Description
Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
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.
Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
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.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
Secondary Outcome Measures
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the 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.
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment 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.
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
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 using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Maximum Concentration (Cmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).
Time to Attain Maximum Concentration (Tmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Apparent Total Body Clearance (CL/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Apparent Volume of Distribution (Vz/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Number of Participants With Adverse Events (AEs)
A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.
Change From Baseline in Post Void Residual (PVR) Volume
Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.
Full Information
NCT ID
NCT01565707
First Posted
March 27, 2012
Last Updated
October 1, 2018
Sponsor
Astellas Pharma Europe B.V.
1. Study Identification
Unique Protocol Identification Number
NCT01565707
Brief Title
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
Acronym
LION
Official Title
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2012 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
January 2, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.
This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Pediatric, Solifenacin succinate suspension, Phase 3, Pharmacokinetics, Overactive bladder (OAB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Children
Arm Type
Placebo Comparator
Arm Description
Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
Arm Title
Solifenacin Succinate Suspension Children
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Adolescents
Arm Type
Placebo Comparator
Arm Description
Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
Arm Title
Solifenacin Succinate Suspension Adolescents
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate Suspension
Other Intervention Name(s)
YM905
Intervention Description
Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
Intervention Type
Behavioral
Intervention Name(s)
Urotherapy
Other Intervention Name(s)
Bladder training
Intervention Description
Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
Description
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
Description
The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the 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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Description
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Description
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Description
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment 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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
Description
The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
Description
The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Description
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
Description
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Time Frame
Baseline and week 12
Title
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
Description
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.
Time Frame
Baseline and Week 12
Title
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Description
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 using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Time Frame
Baseline and Week 12
Title
Maximum Concentration (Cmax) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).
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).
Title
Time to Attain Maximum Concentration (Tmax) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.
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).
Title
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.
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).
Title
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment.
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).
Title
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment.
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).
Title
Apparent Total Body Clearance (CL/F) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment.
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).
Title
Apparent Volume of Distribution (Vz/F) of Solifenacin
Description
Pharmacokinetic sampling was performed at steady state at the end of treatment.
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).
Title
Number of Participants With Adverse Events (AEs)
Description
A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.
Time Frame
From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Title
Change From Baseline in Post Void Residual (PVR) Volume
Description
Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Written Informed Consent has been obtained
OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary
Main Exclusion Criteria:
Daily voiding frequency less than 5
Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
Uroflow indicative of pathology other than OAB
Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
Post Void Residual (PVR) > 20 ml
Monosymptomatic enuresis
Polyuria defined as > 75 ml/kg/b.w./24 hours
Dysfunctional voiding
Congenital anomalies affecting lower urinary tract function
Current constipation
Current Urinary Tract Infection (UTI)
Catheterization within 2 weeks prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Manager
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
Site: 1006
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Site: 1015
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Site: 3202
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Site: 3209
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site: 3208
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Site: 3201
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site: 3203
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site: 3204
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Site: 3205
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site: 5507
City
Campinas
ZIP/Postal Code
13087-567
Country
Brazil
Facility Name
Site: 5506
City
Curitiba
ZIP/Postal Code
80240-060
Country
Brazil
Facility Name
Site: 1005
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Site: 1001
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Site: 4503
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Site: 4501
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Site: 4504
City
Koge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Site: 4502
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Site: 3810
City
Belgrade
ZIP/Postal Code
11 000
Country
Former Serbia and Montenegro
Facility Name
Site: 3812
City
Novi Sad
ZIP/Postal Code
21000
Country
Former Serbia and Montenegro
Facility Name
Site:8203
City
Daegu
ZIP/Postal Code
705717
Country
Korea, Republic of
Facility Name
Site: 8206
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Site: 8207
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Site: 8201
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
Facility Name
Site:8202
City
Seoul
ZIP/Postal Code
156707
Country
Korea, Republic of
Facility Name
Site: 5202
City
Mexico City
ZIP/Postal Code
4530
Country
Mexico
Facility Name
Site: 5205
City
Mexico City
ZIP/Postal Code
C.P.06700
Country
Mexico
Facility Name
Site: 4701
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Site: 4702
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Site: 6301
City
Quezon City
ZIP/Postal Code
1108
Country
Philippines
Facility Name
Site: 4805
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Site: 4803
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Site: 4804
City
Lubin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Site: 4801
City
Warsaw
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Site: 2703
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Site: 4606
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Site: 4601
City
Jonkoping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Site: 4603
City
Skovde
ZIP/Postal Code
54185
Country
Sweden
Facility Name
Site: 4602
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Site: 4605
City
Umea
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Site: 9001
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Site: 9002
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Site: 3853
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Site: 3854
City
Kharkiv
Country
Ukraine
Facility Name
Site: 3850
City
Kiev
ZIP/Postal Code
1103
Country
Ukraine
Facility Name
Site: 4403
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Site: 4401
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
33231929
Citation
Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.
Results Reference
derived
PubMed Identifier
32239291
Citation
Snijder R, Bosman B, Stroosma O, Agema M. Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial. Eur J Pediatr. 2020 Oct;179(10):1523-1528. doi: 10.1007/s00431-020-03635-2. Epub 2020 Apr 1.
Results Reference
derived
PubMed Identifier
27687820
Citation
Newgreen D, Bosman B, Hollestein-Havelaar A, Dahler E, Besuyen R, Sawyer W, Bolduc S, Rittig S. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Eur Urol. 2017 Mar;71(3):483-490. doi: 10.1016/j.eururo.2016.08.061. Epub 2016 Sep 28.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=239
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
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
We'll reach out to this number within 24 hrs