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    Clinical Trial Results:
    The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia.

    Summary
    EudraCT number
    2016-001971-61
    Trial protocol
    NL  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Sep 2020
    First version publication date
    01 Feb 2020
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    first time did not work, new attempt

    Trial information

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    Trial identification
    Sponsor protocol code
    SALYCENDO
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02922673
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    CMO number: 2016-2550, ABR: 57410.091.16
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein 10, Nijmegen, Netherlands,
    Public contact
    Research IC, office of Guus Leijte, Radboudumc, +31 0243668420, guus.leijte@radboudumc.nl
    Scientific contact
    Research IC, office of Guus Leijte, Radboudumc, +31 0243668420, guus.leijte@radboudumc.nl
    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
    08 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance, which is expressed as a decrease in pro-inflammatory cytokine levels between the first and second endotoxin challenge.
    Protection of trial subjects
    Subjects were carefully instructed during the trial.
    Background therapy
    All subjects underwent an endotoxin challenge twice, with an interval of one week in-between.
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 2016
    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
    Netherlands: 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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Healthy male subjects will be recruited by posters at several faculties on the campus of the Radboud University Nijmegen and using the Radboud University website.

    Pre-assignment
    Screening details
    All subjects gave written informed consent and medical history, physical examination, laboratory tests, and a 12-leads electrocardiogram did not reveal any abnormalities.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Subjects will be randomly allocated to prophylaxis, treatment or control group using a sealed envelope opened by a research nurse not involved in the study. The allocated study medication will be delivered in identical packs, as identical capsules, by an independent nurse. The randomization will only be broken only if necessary for safety reasons. The investigators and participating subjects will be blinded for treatment allocation until all study endpoint are known and the database is locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Control group
    Arm description
    control group receiving placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Enteral use
    Dosage and administration details
    Oral use

    Arm title
    Treatment group
    Arm description
    80 mg acetylsalicylic acid daily for the 7-d period in-between both endotoxin challenges
    Arm type
    Experimental

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    PR1
    Other name
    Aspirin
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    80 milligram per day, oral use

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Enteral use
    Dosage and administration details
    Oral use

    Arm title
    Prophylaxis group
    Arm description
    80 mg acetylsalicylic acid daily for a 14-d period,starting 7 d before the first endotoxin challenge
    Arm type
    Experimental

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    PR1
    Other name
    Aspirin
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    80 milligram per day, oral use

    Number of subjects in period 1
    Control group Treatment group Prophylaxis group
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    control group receiving placebo

    Reporting group title
    Treatment group
    Reporting group description
    80 mg acetylsalicylic acid daily for the 7-d period in-between both endotoxin challenges

    Reporting group title
    Prophylaxis group
    Reporting group description
    80 mg acetylsalicylic acid daily for a 14-d period,starting 7 d before the first endotoxin challenge

    Reporting group values
    Control group Treatment group Prophylaxis group Total
    Number of subjects
    10 10 10 30
    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
        arithmetic mean (standard deviation)
    22 ± 2 23 ± 3 22 ± 3 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0 0
        Male
    10 10 10 30

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    control group receiving placebo

    Reporting group title
    Treatment group
    Reporting group description
    80 mg acetylsalicylic acid daily for the 7-d period in-between both endotoxin challenges

    Reporting group title
    Prophylaxis group
    Reporting group description
    80 mg acetylsalicylic acid daily for a 14-d period,starting 7 d before the first endotoxin challenge

    Primary: Area under the TNFa concentration time curve

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    End point title
    Area under the TNFa concentration time curve
    End point description
    Area under the TNFa concentration time curve
    End point type
    Primary
    End point timeframe
    TNF concentration is determined on challenge days from baseline (just before endotoxin administration) up to 8 hours post challenge.
    End point values
    Control group Treatment group Prophylaxis group
    Number of subjects analysed
    10
    10
    10
    Units: pg/mL
        arithmetic mean (standard error)
    23590 ± 4384
    36086 ± 6648
    33257 ± 8312
    Statistical analysis title
    Two-way ANOVA for primary endpoint
    Statistical analysis description
    Two-way ANOVA for cytokine concentration data over time.
    Comparison groups
    Treatment group v Control group v Prophylaxis group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events.
    Adverse event reporting additional description
    The sponsor will report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    ToetsingOnline
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Did not have any AE during this study
    Reporting group description
    Did not have any AE during this study

    Serious adverse events
    Did not have any AE during this study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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%
    Non-serious adverse events
    Did not have any AE during this study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Investigations
    Did not have any AE during this study
    Additional description: Did not have any AE during this study.
         subjects affected / exposed
    1 / 1 (100.00%)
         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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