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    Clinical Trial Results:
    The intestinal disposition of sulindac in healthy volunteers

    Summary
    EudraCT number
    		 2019-001496-36
    Trial protocol
    		 BE  
    Global end of trial date
    17 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2023
    First version publication date
    01 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD19CRCSUL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat, Leuven, Belgium, 3000
    Public contact
    Drug Delivery & Disposition, KU Leuven, glenn.lemmens@kuleuven.be
    Scientific contact
    Drug Delivery & Disposition, KU Leuven, glenn.lemmens@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
    20 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the disposition and bioavailability of Arthrocine at the level of the colon and blood respectively
    Protection of trial subjects
    Only healthy volunteers could participate in this study protocol All colonoscopies were performed by a single experienced endoscopist.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 2019
    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: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Main exclusion criteria: hepatitis B/C and/or HIV infection Illness at the time of the study, allergy for sulindac or NSAIDs in general, medication use (excluding contraceptives) a history of acute/chronic gastrointestinal disease(s) (possible) pregnancy

    Pre-assignment
    Screening details
    		 Healthy volunteers

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 200 mg sulindac
    Arm description
    		 Upon arrival at the endoscopy unit, the volunteers were positioned on their left side and an enema (250 mL of tap water) was administered rectally to rinse the left hemicolon while retaining the physiological state of the right hemicolon. A colonoscopy was then performed by a single experienced endoscopist to obtain two blank biopsies. Next, an Arthrocine tablet (200 mg sulindac) was orally administered with 240 mL of tap water. The colonoscope was left untouched. Between 1 and 2.5 h after drug intake, two caecal biopsies were taken every 15 min with a standard biopsy forceps. After 2.5 h, colonic contents (±2 mL) were sampled through the suction channel of the colonoscope and the colonoscope was retracted. 3 hours later, the colonoscope was positioned again in order to sample caecal biopsies every 15 min between 6 and 7.5 h after drug intake. After 7.5 h, colonic contents were collected and colonoscope was retracted.
    Arm type
    		 Experimental

    Investigational medicinal product name
    sulindac 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One arthrocine tablet (200 mg sulindac) was orally administered with 240 mL of tap water to the volunteers.

    Number of subjects in period 1
    		200 mg sulindac
    Started
    6
    Completed
    5
    Not completed
    1
         failed measurement
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 -

    Reporting group values
    		 overall study Total
    Number of subjects
    		 6 6
    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)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 3 3
        not recorded
    		 1 1
    Subject analysis sets

    Subject analysis set title
    successful measurements
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The measurement of 1 healthy volunteer failed. The data of only 5 volunteers could be analyzed.

    Subject analysis sets values
    		 successful measurements
    Number of subjects
    5
    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)
    5
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    2
        Male
    3
        not recorded
    0

    End points

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    End points reporting groups
    Reporting group title
    200 mg sulindac
    Reporting group description
    		 Upon arrival at the endoscopy unit, the volunteers were positioned on their left side and an enema (250 mL of tap water) was administered rectally to rinse the left hemicolon while retaining the physiological state of the right hemicolon. A colonoscopy was then performed by a single experienced endoscopist to obtain two blank biopsies. Next, an Arthrocine tablet (200 mg sulindac) was orally administered with 240 mL of tap water. The colonoscope was left untouched. Between 1 and 2.5 h after drug intake, two caecal biopsies were taken every 15 min with a standard biopsy forceps. After 2.5 h, colonic contents (±2 mL) were sampled through the suction channel of the colonoscope and the colonoscope was retracted. 3 hours later, the colonoscope was positioned again in order to sample caecal biopsies every 15 min between 6 and 7.5 h after drug intake. After 7.5 h, colonic contents were collected and colonoscope was retracted.

    Subject analysis set title
    successful measurements
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The measurement of 1 healthy volunteer failed. The data of only 5 volunteers could be analyzed.

    Primary: not applicable

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    End point title
    		 not applicable [1]
    End point description
    Since we only conduct exploratory studies in a limited number of volunteers, statistical hypothesis testing is not applicable
    End point type
    Primary
    End point timeframe
    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
    		 200 mg sulindac successful measurements
    Number of subjects analysed
    5 [2]
    5
    Units: not applicable
    5
    5
    Notes
    [2] - 1 measurement failed
    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: there were no adverse events during the trial

    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/33002468
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