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    Clinical Trial Results:
    Supersaturation and precipitation of diclofenac in the stomach of healthy human volunteers

    Summary
    EudraCT number
    		 2013-004636-29
    Trial protocol
    		 BE  
    Global end of trial date
    05 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2023
    First version publication date
    27 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD13DICLO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trial Center UZ Leuven: S56179
    Sponsors
    Sponsor organisation name
    KULeuven / UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Drug Delivery & Disposition, KU Leuven, +32 16379105, patrick.augustijns@kuleuven.be
    Scientific contact
    Drug Delivery & Disposition, KU Leuven, +32 16379105, 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
    22 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aims to investigate principles of gastric supersaturation and precipitation of a weakly acidic drug in healthy human volunteers. Specifically the influence of nutritional state and coadministration of proton-pump inhibitors will be investigated.
    Protection of trial subjects
    Healthy volunteers xylocaine spray/gel during positioning and removal of nasogastric catheter
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2014
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers

    Pre-assignment
    Screening details
    		 Exclusion criteria Volunteers suffering from hepatitis B/C and/or HIV infection were excluded from participation illness at the time of the study, medication use, a history of acute/chronic gastrointestinal disease(s), (possible) pregnancy, frequent exposure to radiation during the previous year

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 cross over: fed vs fasted state
    Arm description
    		 crossover study: administration of one tablet of Cataflam in fed state vs fasted state
    Arm type
    		 Experimental

    Investigational medicinal product name
    diclofenac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    crossover study in which the following conditions were tested: • Administration of one tablet of Cataflam (50 mg diclofenac potassium) with 240 mL of tap water under fasted state conditions. • Administration of one tablet of Cataflam (50 mg diclofenac potassium) with 240 mL of tap water under fed state conditions.

    Arm title
    		 4 arm cross over
    Arm description
    		 administration of a diclofenac potassium solution in fasted and fed state conditions with or without concomitant PPI use.
    Arm type
    		 Experimental

    Investigational medicinal product name
    diclofenac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dissolving one tablet of Cataflam® (50 mg diclofenac potassium) in 240 mL of tap water; the diclofenac potassium solution was orally administered To simulate concomitant PPI use, volunteers were asked to take a tablet of Nexiam® once-daily for 3 days with the first administration 2 days prior to the study.

    Arm title
    		 diclofenac fed state
    Arm description
    		 One tablet of Cataflam (50 mg of diclofenac potassium) was administered with 240 mL of tap water in fed state conditions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    diclofenac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of Cataflam (50 mg of diclofenac potassium) was administered with 240 mL of tap water in fed state conditions.

    Number of subjects in period 1
    		cross over: fed vs fasted state 4 arm cross over diclofenac fed state
    Started
    6
    5
    5
    Completed
    6
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    cross over: fed vs fasted state
    Reporting group description
    		 crossover study: administration of one tablet of Cataflam in fed state vs fasted state

    Reporting group title
    4 arm cross over
    Reporting group description
    		 administration of a diclofenac potassium solution in fasted and fed state conditions with or without concomitant PPI use.

    Reporting group title
    diclofenac fed state
    Reporting group description
    		 One tablet of Cataflam (50 mg of diclofenac potassium) was administered with 240 mL of tap water in fed state conditions.

    Reporting group values
    		 cross over: fed vs fasted state 4 arm cross over diclofenac fed state Total
    Number of subjects
    		 6 5 5 16
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 5 5 16
    Gender categorical
    Units: Subjects
        Female
    		 2 3 2 7
        Male
    		 4 2 3 9

    End points

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    End points reporting groups
    Reporting group title
    cross over: fed vs fasted state
    Reporting group description
    		 crossover study: administration of one tablet of Cataflam in fed state vs fasted state

    Reporting group title
    4 arm cross over
    Reporting group description
    		 administration of a diclofenac potassium solution in fasted and fed state conditions with or without concomitant PPI use.

    Reporting group title
    diclofenac fed state
    Reporting group description
    		 One tablet of Cataflam (50 mg of diclofenac potassium) was administered with 240 mL of tap water in fed state conditions.

    Primary: diclofenac concentrations

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    End point title
    		 diclofenac concentrations [1]
    End point description
    End point type
    Primary
    End point timeframe
    Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable
    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: Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable
    End point values
    		 cross over: fed vs fasted state 4 arm cross over diclofenac fed state
    Number of subjects analysed
    6
    5
    5
    Units: nM
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
    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: The healthy volunteers did not report any adverse event 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/28621952
    http://www.ncbi.nlm.nih.gov/pubmed/26375734
    http://www.ncbi.nlm.nih.gov/pubmed/30571131
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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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