Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    The use of the non-absorbable marker paromomycin sulfate for the evaluation of the gastrointestinal transit

    Summary
    EudraCT number
    		 2013-000297-30
    Trial protocol
    		 BE  
    Global end of trial date
    29 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2023
    First version publication date
    09 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DDD13PM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trial Center UZ Leuven: S55196
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Drug Delivery & Disposition, KU Leuven, 32 16330302, patrick.augustijns@kuleuven.be
    Scientific contact
    Drug Delivery & Disposition, KU Leuven, 32 16330302, 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
    02 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the gastrointestinal transit by the non-absorbable marker paromomycin sulfate
    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
    15 May 2013
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Main exclusion criteria: (potential) pregnancy, frequent exposure to ionizing radiation in the previous year, history of gastrointestinal pathology and/or illness at the time of the study. hepatitis B/C- or HIV-infected subjects

    Pre-assignment
    Screening details
    		 Healthy volunteers

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 paromomycin during MMC phase I
    Arm description
    		 paromomycin 250mg during MMC phase I
    Arm type
    		 Experimental

    Investigational medicinal product name
    paromomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration of one tablet of Gabbroral (250 mg paromomycin) with 240 mL of tap water during MMC phase I (i.e. absence of contractions).

    Arm title
    		 paromomycin during MMC phase II
    Arm description
    		 paromomycin 250mg during MMC phase II
    Arm type
    		 Experimental

    Investigational medicinal product name
    paromomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration of one tablet of Gabbroral (250 mg paromomycin) with 240 mL of tap water during MMC phase II (i.e. period of gastric contractions).

    Number of subjects in period 1
    		paromomycin during MMC phase I paromomycin during MMC phase II
    Started
    8
    8
    Completed
    8
    8

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 -

    Reporting group values
    		 overall study Total
    Number of subjects
    		 8 8
    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
        median (full range (min-max))
    		 24 (20 to 26) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 6 6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    paromomycin during MMC phase I
    Reporting group description
    		 paromomycin 250mg during MMC phase I

    Reporting group title
    paromomycin during MMC phase II
    Reporting group description
    		 paromomycin 250mg during MMC phase II

    Primary: not applicable

    		 Close Top of page
    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
    		 paromomycin during MMC phase I paromomycin during MMC phase II
    Number of subjects analysed
    8
    8
    Units: NA
    8
    8
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    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

    		 Close Top of page

    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/27865990
    http://www.ncbi.nlm.nih.gov/pubmed/25064697
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Nov 04 05:01:38 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA