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    Clinical Trial Results:
    The effect of sparkling water on the systemic pharmacokinetics of paracetamol in elderly

    Summary
    EudraCT number
    		 2022-003248-28
    Trial protocol
    		 BE  
    Global end of trial date
    08 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2024
    First version publication date
    27 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD22WATER
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trial Center UZ Leuven identifier: S67145
    Sponsors
    Sponsor organisation name
    KU Leuven Drug Delivery and Disposition
    Sponsor organisation address
    Gasthuisberg ON2, Herestraat 49 box 921, Leuven, Belgium, 3000
    Public contact
    Patrick Augustijns, KU Leuven Drug Delivery and Disposition, +32 16330301, patrick.augustijns@kuleuven.be
    Scientific contact
    Patrick Augustijns, KU Leuven Drug Delivery and Disposition, +32 16330301, patrick.augustijns@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
    19 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of sparkling water instead of tap water on the early absorption of paracetamol in older adults, as measured by the systemic AUC0-30 min.
    Protection of trial subjects
    - Trial only involved intake of a single dose of an authorized oral drug product according to SPC (Dafalgan 500 mg). - Standard procedures for placement of a venous catheter to sample systemic blood.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2023
    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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    0
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Informative flyers were distributed to recruit volunteers in Belgium between March and November 2023.

    Pre-assignment
    Screening details
    		 Candidate participants were screened for in- and exclusion criteria. Inclusion: 70 years or older, no clinically significant abnormalities, written informed consent Exclusion: history of gastrointestinal disease, hepatic cirrhosis, renal impairment, recent intake of gastric motility-modifying medication

    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
    No

    Arm title
    		 Still water
    Arm description
    		 Systemic disposition of paracetamol after oral intake of 1 tablet of Dafalgan (paracetamol 500 mg) with 240 mL of still water (Spa Reine).
    Arm type
    		 Experimental

    Investigational medicinal product name
    paracetamol (Dafalgan)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paracetamol (500 mg) was orally administered as 1 tablet of Dafalgan with 240 mL still water.

    Arm title
    		 Sparkling water
    Arm description
    		 Systemic disposition of paracetamol after oral intake of 1 tablet of Dafalgan (paracetamol 500 mg) with 240 mL of sparkling water (Spa Intense).
    Arm type
    		 Experimental

    Investigational medicinal product name
    paracetamol (Dafalgan)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paracetamol (500 mg) was orally administered as 1 tablet of Dafalgan with 240 mL sparkling water.

    Number of subjects in period 1
    		Still water Sparkling water
    Started
    14
    14
    Completed
    14
    14

    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
    		 14 14
    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)
    		 0 0
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 72.5 (70 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Still water
    Reporting group description
    		 Systemic disposition of paracetamol after oral intake of 1 tablet of Dafalgan (paracetamol 500 mg) with 240 mL of still water (Spa Reine).

    Reporting group title
    Sparkling water
    Reporting group description
    		 Systemic disposition of paracetamol after oral intake of 1 tablet of Dafalgan (paracetamol 500 mg) with 240 mL of sparkling water (Spa Intense).

    Primary: Early exposure to paracetamol: AUC 0-30 min

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    End point title
    		 Early exposure to paracetamol: AUC 0-30 min
    End point description
    End point type
    Primary
    End point timeframe
    0-30 min post drug intake
    End point values
    		 Still water Sparkling water
    Number of subjects analysed
    14
    14
    Units: min*µM
        geometric mean (geometric coefficient of variation)
    526 ( 136 )
    828 ( 63.2 )
    Statistical analysis title
    		 Still vs sparkling: paired t-test
    Comparison groups
    Still water v Sparkling water
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.1263
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Paired 2-sided t-test

    Secondary: Overall exposure to paracetamol: AUC 0-inf

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    End point title
    		 Overall exposure to paracetamol: AUC 0-inf
    End point description
    End point type
    Secondary
    End point timeframe
    0 min - infinity post drug intake
    End point values
    		 Still water Sparkling water
    Number of subjects analysed
    14
    14
    Units: min*µM
        geometric mean (geometric coefficient of variation)
    10300 ( 24.6 )
    10400 ( 25.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first visit of first subject till last visit of last subject.
    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: No adverse events happened during the study.

    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.
    Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39019296
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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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