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    Clinical Trial Results:
    A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Phase 2, Dose Ranging Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral Litoxetine 10mg,20mg and 40mg Twice Daily (BID) versus Placebo in Women with Mixed Urinary Incontinence

    Summary
    EudraCT number
    		 2016-004307-30
    Trial protocol
    		 PL   FR   GB  
    Global end of trial date
    13 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2019
    First version publication date
    31 May 2019
    Other versions
    Summary report(s)
    		 CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    IXA-CSP-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 VHP REFERENCE NUMBER: VHP-No: VHP1022 (VHP2016175)
    Sponsors
    Sponsor organisation name
    Ixaltis SA
    Sponsor organisation address
    Archamps Technopole, 60 avenue Marie Curie, Archamps, France, 74160
    Public contact
    Elisabeth Svanberg, Ixaltis SA, 33 457260076, svanberg@ixaltis.com
    Scientific contact
    Elisabeth Svanberg, Ixaltis SA, 33 457260076, svanberg@ixaltis.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the effectiveness of the 3 doses of Litoxetine (10mgs,20mgs,and 40mgs taken two times per day)versus placebo (inactive substance). Female adult patients will take part with a diagnosis of Mixed Urinary Incontinence (MUI)
    Protection of trial subjects
    Adherence to GCP and Declaration of Helsinki, local law and regulation, protocol and ICF approved by IRB/EC
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2017
    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: 35
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Georgia: 58
    Country: Number of subjects enrolled
    Ukraine: 77
    Worldwide total number of subjects
    198
    EEA total number of subjects
    39
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    134
    From 65 to 84 years
    64
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in Canada, France, Georgia, Poland, UK, Ukraine March 2017 - May 2018

    Pre-assignment
    Screening details
    		 Women age 18-75 years of age Urinary Incontinence of at least 3 months duration

    Pre-assignment period milestones
    Number of subjects started
    		 198
    Number of subjects completed
    		 198

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 placebo
    Arm description
    		 placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    10, 20 or 40 mg BID

    Number of subjects in period 1
    		placebo
    Started
    198
    Completed
    198
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Litoxetine 10 mg BID
    Arm description
    		 Litoxetine 10 mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litoxetine benzoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg BID

    Arm title
    		 Litoxetine 20 mg BID
    Arm description
    		 Litoxetine 20 mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litoxetine benzoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Litoxetine 20 mg BID

    Arm title
    		 Litoxetine 40 mg BID
    Arm description
    		 Litoxetine 40 mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Litoxetine benzoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Litoxetine 40 mg BID

    Arm title
    		 placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    placebo BID

    Number of subjects in period 2
    		Litoxetine 10 mg BID Litoxetine 20 mg BID Litoxetine 40 mg BID placebo
    Started
    48
    52
    48
    50
    Completed
    48
    52
    48
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo

    Reporting group values
    		 placebo Total
    Number of subjects
    		 198 198
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 57 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    		 198 198
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The 4 arms in the treatment period are used for the analysis of study data.

    Subject analysis sets values
    		 Per protocol population
    Number of subjects
    164
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (standard deviation)
    57 ± 12
    Gender categorical
    Units: Subjects
        Female
    164
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo
    Reporting group title
    Litoxetine 10 mg BID
    Reporting group description
    		 Litoxetine 10 mg BID

    Reporting group title
    Litoxetine 20 mg BID
    Reporting group description
    		 Litoxetine 20 mg BID

    Reporting group title
    Litoxetine 40 mg BID
    Reporting group description
    		 Litoxetine 40 mg BID

    Reporting group title
    placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The 4 arms in the treatment period are used for the analysis of study data.

    Primary: Change in incontinence event frequency

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    End point title
    		 Change in incontinence event frequency
    End point description
    Change in number of incontinence episodes/ week
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Litoxetine 10 mg BID Litoxetine 20 mg BID Litoxetine 40 mg BID placebo Per protocol population
    Number of subjects analysed
    39
    45
    34
    46
    164
    Units: events/week
        number (confidence interval 95%)
    0.51 (0.37 to 0.69)
    0.52 (0.40 to 0.69)
    0.38 (0.26 to 0.55)
    0.49 (0.35 to 0.67)
    1 (1 to 1)
    Attachments
    		 Ph 2 efficacy
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    Comparison was made between the 40 mg BID group and the plkacebo group, and subsequenbtly between the 20 mg BID and 10 mg BID group to placebo
    Comparison groups
    Litoxetine 10 mg BID v Litoxetine 20 mg BID v Litoxetine 40 mg BID v placebo
    Number of subjects included in analysis
    164
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    March 2017- October 2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 198 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.02%
    Non-serious adverse events
    		 Treatment period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 198 (19.70%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 198 (1.52%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 198 (3.54%)
         occurrences all number
    7
    General disorders and administration site conditions
    Asthenia
    Additional description: The reporting includes also the term 'fatigue'
         subjects affected / exposed
    5 / 198 (2.53%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 198 (7.58%)
         occurrences all number
    16
    Vomiting
         subjects affected / exposed
    4 / 198 (2.02%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    3 / 198 (1.52%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 198 (1.52%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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