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    Clinical Trial Results:
    The effect of hydroxychloroquine sulphate on hedonic food intake, appetite-related sensations and gastrointestinal hormone release in healthy female subjects

    Summary
    EudraCT number
    		 2018-003083-30
    Trial protocol
    		 BE  
    Global end of trial date
    22 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2021
    First version publication date
    10 Feb 2021
    Other versions
    Summary report(s)
    		 Data plaquenil study

    Trial information

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    Trial identification
    Sponsor protocol code
    PLAQHV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, KU Leuven, +32 16344225, jan.tack@kuleuven.be
    Scientific contact
    TARGID, KU Leuven, +32 16344225, jan.tack@kuleuven.be
    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
    14 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To detect changes in hedonic food intake after acute administration of hydroxychloroquine sulphate compared to placebo.
    Protection of trial subjects
    Identification of trial subjects was protected by the implementation of subject identification numbers
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2018
    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
    Belgium: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy volunteers were included for this study.

    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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Plaquenil
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hydroxychloroquine sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 tablets of 200mg hydroxychloroquine sulphate

    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
    2 placebo tablets

    Number of subjects in period 1
    		Plaquenil Placebo
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 10 10
    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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 23.8 (20 to 27) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Plaquenil
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Changes of hunger from baseline

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    End point title
    		 Changes of hunger from baseline
    End point description
    End point type
    Primary
    End point timeframe
    Comparison between visit 1 and visit 2
    End point values
    		 Plaquenil Placebo
    Number of subjects analysed
    10
    10
    Units: mm
        arithmetic mean (standard error)
    5.6 ± 3.1
    6.7 ± 4.2
    Statistical analysis title
    		 Mixed models for hunger
    Comparison groups
    Plaquenil v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.044
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From signing the informed consent until the end of visit 2.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Hunger and headache were reported in this study during both conditions. This was due to the study protocol, subjects needed to be fasted, and not due to the administration of the investigation medicinal product.

    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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