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    Clinical Trial Results:
    A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of age with Neurogenic Detrusor Overactivity (NDO)

    Summary
    EudraCT number
    2011-000250-28
    Trial protocol
    BE   GB   DK  
    Global end of trial date
    13 Aug 2012

    Results information
    Results version number
    v2(current)
    This version publication date
    22 Sep 2016
    First version publication date
    11 Jul 2015
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    905-CL-079
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01539707
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetics (PK) of solifenacin succinate suspension after single-dose administration in children and adolescents with NDO.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    7
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Children and adolescents with NDO (confirmed by urodynamics), who consented to enter this study and fulfilled all the eligibility criteria, were enrolled in this study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AD-PED 5.0 mg
    Arm description
    Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.
    Arm type
    Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Adolescents were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

    Arm title
    CH-PED 5.0 mg
    Arm description
    Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.
    Arm type
    Experimental

    Investigational medicinal product name
    Solifenacin succinate suspension
    Investigational medicinal product code
    YM905
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Children were given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses were calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).

    Number of subjects in period 1
    AD-PED 5.0 mg CH-PED 5.0 mg
    Started
    8
    7
    Treated
    7
    7
    Completed
    7
    7
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AD-PED 5.0 mg
    Reporting group description
    Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 5.0 mg
    Reporting group description
    Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group values
    AD-PED 5.0 mg CH-PED 5.0 mg Total
    Number of subjects
    8 7 15
    Age categorical
    Units: Subjects
        Children (2-11 years)
    0 7 7
        Adolescents (12-17 years)
    8 0 8
    Age continuous
    This baseline characteristic was based on the Safety Analysis Set (SAF), which consisted of all enrolled participants who received any dose of study drug. As a participant in the AD-PED 5.0 mg did not receive any study drug, his age was not included in this calculation.
    Units: years
        arithmetic mean (standard deviation)
    14.4 ± 2.07 8.6 ± 1.72 -
    Gender categorical
    Units: Subjects
        Female
    4 3 7
        Male
    4 4 8

    End points

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    End points reporting groups
    Reporting group title
    AD-PED 5.0 mg
    Reporting group description
    Male and female adolescents aged 12 to less than 18 years old who received pediatric equivalent dose (PED) of 5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 5.0 mg
    Reporting group description
    Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.

    Primary: Maximum concentration (Cmax)

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    End point title
    Maximum concentration (Cmax) [1]
    End point description
    The analysis population was the pharmacokinetic analysis set (PKAS), which consisted of all participants who received any dose of study drug and who had values of solifenacin concentration for a sufficient number of time points to reliably calculate at least 1 pharmacokinetic parameter. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: ng/mL
        arithmetic mean (standard deviation)
    21.906 ± 7.931
    17.666 ± 5.8884
    No statistical analyses for this end point

    Primary: Time to attain Cmax (tmax)

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    End point title
    Time to attain Cmax (tmax) [2]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: hours
        arithmetic mean (standard deviation)
    3.87 ± 1.119
    4.16 ± 1.055
    No statistical analyses for this end point

    Primary: Area under the curve extrapolated to infinity (AUCinf)

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    End point title
    Area under the curve extrapolated to infinity (AUCinf) [3]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    1614.771 ± 954.6774
    831.873 ± 329.5083
    No statistical analyses for this end point

    Primary: Apparent terminal elimination half-life (t1/2)

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    End point title
    Apparent terminal elimination half-life (t1/2) [4]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: hours
        arithmetic mean (standard deviation)
    52.877 ± 21.0715
    30.653 ± 8.275
    No statistical analyses for this end point

    Primary: Apparent total body clearance (CL/F)

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    End point title
    Apparent total body clearance (CL/F) [5]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: L/h
        arithmetic mean (standard deviation)
    7.707 ± 4.8032
    7.216 ± 4.0233
    No statistical analyses for this end point

    Primary: Apparent volume of distribution during the terminal phase (Vz/F)

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    End point title
    Apparent volume of distribution during the terminal phase (Vz/F) [6]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: liters
        arithmetic mean (standard deviation)
    499.397 ± 195.1213
    298.923 ± 108.4731
    No statistical analyses for this end point

    Primary: Area under the concentration-time curve from the time of dosing until the last measurable concentration (AUClast)

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    End point title
    Area under the concentration-time curve from the time of dosing until the last measurable concentration (AUClast) [7]
    End point description
    The analysis population was the PKAS. The number of samples as well sampling times depended on the age of the participant (aged 5-less than 9 years old: 4 samples; aged 9-less than 12 years old: 6 samples; aged 12-less than 18 years old: 7 samples).
    End point type
    Primary
    End point timeframe
    Day 1 predose up to Day 7 postdose
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study was written with no planned statistical analyses (statistical hypothesis testing) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    1298.827 ± 604.7748
    769.354 ± 307.4642
    No statistical analyses for this end point

    Secondary: Safety as assessed by adverse events (AEs), vital signs, clinical laboratory evaluations, physical examination and electrocardiograms (ECGs)

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    End point title
    Safety as assessed by adverse events (AEs), vital signs, clinical laboratory evaluations, physical examination and electrocardiograms (ECGs)
    End point description
    Safety was monitored by collecting AEs, which included abnormal laboratory tests, vital signs or ECG data that were defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred or worsened after study drug administration. A serious AE was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly, or birth defect, required inpatient hospitalization or led to prolongation of hospitalization. The analysis population was the SAF, which consisted of all enrolled participants who received the dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 7 days postdose
    End point values
    AD-PED 5.0 mg CH-PED 5.0 mg
    Number of subjects analysed
    7
    7
    Units: participants
        Participants experienced AEs
    2
    0
        Number of AEs
    5
    0
        Participants experienced drug-related AEs
    0
    0
        Deaths
    0
    0
        Participants experienced SAEs
    0
    0
        Participants with AEs leading to discontinuation
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 7 days postdose
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    AD-PED 5.0 mg
    Reporting group description
    Male and female adolescents aged 12 to less than 18 years old who received PED of 5 mg of solifenacin succinate.

    Reporting group title
    CH-PED 5.0 mg
    Reporting group description
    Male and female children aged 5 to less than 12 years old who received PED of 5 mg of solifenacin succinate.

    Serious adverse events
    AD-PED 5.0 mg CH-PED 5.0 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    AD-PED 5.0 mg CH-PED 5.0 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2012
    The reason for the substantial amendment was to clarify: the terminology of the exclusion criteria, the analysis of pharmacokinetics, the study design and the dose rationale, reporting of SAEs, the safety assessment, the test drug concentration and the events always considered to be serious. Two new exclusion criteria, clinical research contact information, and reference to a relevant newly completed study (Study 905-CL-075) were added.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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