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    Clinical Trial Results:
    Urodynamic evaluation by pressure flow urodynamic study of the new α1A-adrenoceptor antagonist silodosin 8 mg qd in patients with benign prostatic obstruction. Explorative, single-arm, phase IV clinical study.

    Summary
    EudraCT number
    		 2015-002277-38
    Trial protocol
    		 IT  
    Global end of trial date
    16 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2018
    First version publication date
    15 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KMD3213ITCL0477
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Recordati SPA
    Sponsor organisation address
    Via Civitali, 1, Milan, Italy, 20148
    Public contact
    Direzione Medica, Recordati S.p.A., +39 0248787456, casi.m@recordati.it
    Scientific contact
    Direzione Medica, Recordati S.p.A., +39 0248787456, casi.m@recordati.it
    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
    20 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the effects of silodosin on the change from baseline in Bladder Outlet Obstruction Index (BOOI).
    Protection of trial subjects
    None required
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2015
    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
    Italy: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    16
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening period of up to 1 week of duration.

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

    Arms
    Arm title
    		 Silodosin 8 mg
    Arm description
    		 the subjects fulfilling all the selection criteria entered a 8-week, open-label, active treatment phase with silodosin 8 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Silodosin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Silodosin 8 mg oad per oral route

    Number of subjects in period 1
    		Silodosin 8 mg
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Men at least 50 years of age, with a diagnosis of presence of LUTS, with bladder outlet obstruction (BOO) associated with BPH, waiting for surgical treatment, were evaluated in this clinical study.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Silodosin 8 mg
    Reporting group description
    		 the subjects fulfilling all the selection criteria entered a 8-week, open-label, active treatment phase with silodosin 8 mg

    Primary: Change from baseline in Bladder Outlet Obstruction Index (BOOI)

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    End point title
    		 Change from baseline in Bladder Outlet Obstruction Index (BOOI) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline after 8 weeks of treatment with Silodosin 8 mg
    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: Only descriptive statistics have been performed for this study. No inferential statistical analysis has been performed.
    End point values
    		 Silodosin 8 mg
    Number of subjects analysed
    30
    Units: Score
        arithmetic mean (standard deviation)
    -31.4 ± 22.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were documented from Visit 1 up to the final visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Treatment Emergent AEs
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment Emergent AEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Treatment Emergent AEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 30 (36.67%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Retrograde ejaculation
         subjects affected / exposed
    8 / 30 (26.67%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    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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