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    Clinical Trial Results:
    Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

    Summary
    EudraCT number
    		 2013-003328-35
    Trial protocol
    		 FR  
    Global end of trial date
    01 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2022
    First version publication date
    13 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHD062-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02090439
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Hospitalier Départemental Vendée
    Sponsor organisation address
    Boulevard Stéphane MOREAU, Visioconférence, France, 85925
    Public contact
    MOREAU Chloé, Centre Hospitalier Départemental Vendée, +33 0251446327, chloe.moreau@ght85.fr
    Scientific contact
    Dr. LUYCKX François, Centre Hospitalier Départemental Vendée, +33 02 51 44 61 46, francois.luyckx@ght85.fr
    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
    27 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Increase in the rate of spontaneous expulsion of pelvic stones from 4 to 10 mm in the Silodosine group compared to the reference group
    Protection of trial subjects
    All adverse events or reactions (except those specified in the protocol), whether expected or unexpected, serious or not, were collected in the eCRF. The follow-up of events or adverse reactions, serious or not, was ensured until resolution or consolidation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 8 patients were screened for inclusion

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard treatment
    Arm description
    		 Analgesics, non-steroidal anti-inflammatory drugs and control of fluid intake.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Analgesics
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    7 days of paracetamol

    Investigational medicinal product name
    Non-steroidal anti-inflammatory
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    7 days of ketoprofen

    Arm title
    		 Standard treatment associated with Urorec
    Arm description
    		 Standard treatment and Urorec for 14 days then 14 days of Urorec alone: - 7 days of Urorec + paracetamol + ketoprofen + fluid control - then 7 days of Urorec + paracetamol + fluid control - then 14 days of Urorec + fluid control
    Arm type
    		 Experimental

    Investigational medicinal product name
    Urorec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg/g - per day

    Investigational medicinal product name
    Analgesics
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    7 days of paracetamol

    Investigational medicinal product name
    Non-steroidal anti-inflammatory
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    7 days of ketoprofen

    Number of subjects in period 1
    		Standard treatment Standard treatment associated with Urorec
    Started
    4
    4
    Inclusion
    4
    4
    J14 - intermediate visit
    4
    3
    J28 - intermediate visit
    4
    3
    J32 - End of study (telephone contact)
    4
    3
    Completed
    4
    3
    Not completed
    0
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard treatment
    Reporting group description
    		 Analgesics, non-steroidal anti-inflammatory drugs and control of fluid intake.

    Reporting group title
    Standard treatment associated with Urorec
    Reporting group description
    		 Standard treatment and Urorec for 14 days then 14 days of Urorec alone: - 7 days of Urorec + paracetamol + ketoprofen + fluid control - then 7 days of Urorec + paracetamol + fluid control - then 14 days of Urorec + fluid control

    Reporting group values
    		 Standard treatment Standard treatment associated with Urorec Total
    Number of subjects
    		 4 4 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 4 4 8
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.75 ( 8.54 ) 40.75 ( 9.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 0 1
        Male
    		 3 4 7

    End points

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    End points reporting groups
    Reporting group title
    Standard treatment
    Reporting group description
    		 Analgesics, non-steroidal anti-inflammatory drugs and control of fluid intake.

    Reporting group title
    Standard treatment associated with Urorec
    Reporting group description
    		 Standard treatment and Urorec for 14 days then 14 days of Urorec alone: - 7 days of Urorec + paracetamol + ketoprofen + fluid control - then 7 days of Urorec + paracetamol + fluid control - then 14 days of Urorec + fluid control

    Primary: Spontaneous expulsion of the pelvic stone

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    End point title
    		 Spontaneous expulsion of the pelvic stone [1]
    End point description
    Lithiasic elimination will be proven by : -a stone brought by the patient to the consultation and analyzed by infrared spectrophotometry (SPIR), in case of a single stone at inclusion. - a stone brought by the patient, with proof of elimination of the single pelvic stone by ASP +/- control scanner, in the case of pelvic stone associated with other calcareous stones at inclusion. -if the stone could not be recovered, a non-injection abdominal CT scan with no stone at D28.
    End point type
    Primary
    End point timeframe
    28 days
    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: The study was stopped prematurely (recruitment difficulties). No statistical analysis was performed.
    End point values
    		 Standard treatment Standard treatment associated with Urorec
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Yes or no
    Notes
    [2] - Premature termination of the study no statistical analysis was performed
    [3] - Premature termination of the study no statistical analysis was performed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date the consent is signed until D32 (+/-1 day), i.e. 3 to 5 days after the last treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Standard support
    Reporting group description
    		 Analgesics, non-steroidal anti-inflammatory drugs and control of water intake (14 days of treatment): - 7 days of paracetamol + ketoprofen + water intake control - Then 7 days of paracetamol + control of water intake.

    Reporting group title
    Standard support associated with Urorec
    Reporting group description
    		 Standard treatment and Urorec for 14 days and then 14 days of Urorec alone: - 7 days of Urorec + paracetamol + ketoprofen + water intake control - then 7 days of Urorec + paracetamol + water intake control - then 14 days of Urorec + water intake control

    Serious adverse events
    		 Standard support Standard support associated with Urorec
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Urethral pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Standard support Standard support associated with Urorec
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 4 (75.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    2
    Somnolence
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Retrograde ejaculation
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2014
    Update from the co-investigators at CHD Vendee.
    30 Oct 2014
    Updated inclusion criteria: inclusion of patients with a single pelvic ureteral stone with a transverse diameter of 4 to 10 mm, with or without calcareous (non-obstructive) calculi, but without other ureteral stones.
    11 Apr 2015
    Update from the co-investigators at CHD Vendee.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Dec 2015
    The very sustained activity of the urology department, combined with the difficulty in accessing low-dose spiral scanners in the CHD, as well as the random participation of the emergency team in recruitment due to the lack of presence of the principal investigator (a very important clinical activity) contributed to this failure. Protocol writing and safety were not an issue.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was prematurely stopped with only 8 patients included out of 160 planned due to organizational and recruitment problems. No risk related to protocol treatment was identified. No statistical analysis was performed.
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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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