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    Clinical Trial Results:
    A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-selection study of S-600918 in patients with refractory chronic cough

    Summary
    EudraCT number
    		 2019-002283-27
    Trial protocol
    		 GB   CZ   PL  
    Global end of trial date
    28 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1812VA323
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04110054
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shionogi B.V.
    Sponsor organisation address
    Kingsfordweg 151, Amsterdam, Netherlands, 1043 GR
    Public contact
    Regulatory Affairs, Shionogi B.V., +44 2030534200, shionogiclintrials-admin@shionogi.co.jp
    Scientific contact
    Regulatory Affairs, Shionogi B.V., +44 2030534200, shionogiclintrials-admin@shionogi.co.jp
    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
    28 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo
    Protection of trial subjects
    The study was conducted in accordance with the protocol approved by the IRB/IEC, all applicable regulatory requirements (including patient privacy requirements), current ICH GCP, and the ethical principles outlined in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2020
    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: 49
    Country: Number of subjects enrolled
    United Kingdom: 38
    Country: Number of subjects enrolled
    Czechia: 29
    Country: Number of subjects enrolled
    United States: 150
    Country: Number of subjects enrolled
    Japan: 91
    Country: Number of subjects enrolled
    Ukraine: 49
    Worldwide total number of subjects
    406
    EEA total number of subjects
    78
    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)
    285
    From 65 to 84 years
    121
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were screened prior to enrollment

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active 50mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    S-600918
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg, 150mg or 300mg, once daily for 4 weeks

    Arm title
    		 Active 150mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    S-600918
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg, 150mg or 300mg, once daily for 4 weeks

    Arm title
    		 Active 300mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    S-600918
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg, 150mg or 300mg, once daily for 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily for 4 weeks

    Number of subjects in period 1
    		Active 50mg Active 150mg Active 300mg Placebo
    Started
    101
    103
    100
    102
    Completed
    100
    99
    92
    99
    Not completed
    1
    4
    8
    3
         Consent withdrawn by subject
    -
    3
    2
    -
         Adverse event, non-fatal
    1
    1
    4
    3
         Covid-19
    -
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active 50mg
    Reporting group description
    		 -

    Reporting group title
    Active 150mg
    Reporting group description
    		 -

    Reporting group title
    Active 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Active 50mg Active 150mg Active 300mg Placebo Total
    Number of subjects
    		 101 103 100 102 406
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 63 70 74 78 285
        From 65-84 years
    		 38 33 26 24 121
    Gender categorical
    Units: Subjects
        Female
    		 79 76 68 77 300
        Male
    		 22 27 32 25 106

    End points

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    End points reporting groups
    Reporting group title
    Active 50mg
    Reporting group description
    		 -

    Reporting group title
    Active 150mg
    Reporting group description
    		 -

    Reporting group title
    Active 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Percent Change in Hourly Cough Counts in 24 Hours

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    End point title
    		 Percent Change in Hourly Cough Counts in 24 Hours [1]
    End point description
    End point type
    Primary
    End point timeframe
    Following 4 weeks of treatment
    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: No statistical analyses have been uploaded
    End point values
    		 Active 50mg Active 150mg Active 300mg Placebo
    Number of subjects analysed
    100
    102
    96
    99
    Units: percent change in hourly cough count
        geometric mean (confidence interval 95%)
    -55.16 (-55.16 to -55.16)
    -61.08 (-61.08 to -61.08)
    -65.32 (-65.32 to -65.32)
    -60.38 (-60.38 to -60.38)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Active - 50mg
    Reporting group description
    		 -

    Reporting group title
    Active - 150 mg
    Reporting group description
    		 -

    Reporting group title
    Active - 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active - 50mg Active - 150 mg Active - 300mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 103 (0.00%)
    0 / 100 (0.00%)
    0 / 102 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active - 50mg Active - 150 mg Active - 300mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 101 (4.95%)
    15 / 103 (14.56%)
    34 / 100 (34.00%)
    10 / 102 (9.80%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 101 (1.98%)
    12 / 103 (11.65%)
    27 / 100 (27.00%)
    3 / 102 (2.94%)
         occurrences all number
    2
    12
    27
    3
    Headache
         subjects affected / exposed
    3 / 101 (2.97%)
    2 / 103 (1.94%)
    1 / 100 (1.00%)
    7 / 102 (6.86%)
         occurrences all number
    3
    2
    1
    7
    Hypogeusia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 103 (0.97%)
    6 / 100 (6.00%)
    0 / 102 (0.00%)
         occurrences all number
    0
    1
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Sep 2020
    Inclusion of COVID-19 measures. Amendment was not considered substantial in all countries

    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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