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    Clinical Trial Results:
    Invloed van Somatuline® autogel 120mg op post-operatieve drainage na rectumresectie voor rectumcarcinoom

    Summary
    EudraCT number
    		 2010-022572-32
    Trial protocol
    		 BE  
    Global end of trial date
    31 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2024
    First version publication date
    04 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2010/005 (A-48-52030-740)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Ghent
    Sponsor organisation address
    C. Heymanslaan, Ghent, Belgium, 9000
    Public contact
    Trial Bureau, Ghent University Hospital, 32 93320530, hiruz.ctu@uzgent.be
    Scientific contact
    Trial Bureau, Ghent University Hospital, 32 93320530, hiruz.ctu@uzgent.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
    31 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Nagaan van het effect van een éénmalige diep onderhuidse injectie met Somatuline® autogel 120 mg op de productie van drainvocht postoperatief.
    Protection of trial subjects
    If the subjects are not under 24-hour supervision of the investigator or his/her staff (out-patients, volunteers), they (or their designee, if appropriate) must be provided with a "trial card" indicating the name of the investigational product, the trial number, the investigator's name and a 24-hour emergency contact number.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2011
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 NAP

    Pre-assignment
    Screening details
    		 NAP

    Period 1
    Period 1 title
    Overal Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Somatuline
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Somatuline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    Het doel van deze studie is na te gaan wat het effect is van een éénmalige diep onderhuidse injectie met Somatuline® autogel 120 mg versus een éénmalige diep onderhuidse placebo-injectie, op de productie van drainvocht postoperatief

    Arm title
    		 Placebo
    Arm description
    		 placebo-injectie met natriumchloride 0.9%
    Arm type
    		 Placebo

    Investigational medicinal product name
    natriumchloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    natriumchloride 0.9%

    Number of subjects in period 1
    		Somatuline Placebo
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 placebo-injectie met natriumchloride 0.9%

    Primary: Primary

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    End point title
    		 Primary [1]
    End point description
    Het doel van deze studie is na te gaan wat het effect is van een éénmalige diep onderhuidse injectie met Somatuline® autogel 120 mg versus een éénmalige diep onderhuidse placebo-injectie, op de productie van drainvocht postoperatief.
    End point type
    Primary
    End point timeframe
    during the study
    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: NAP
    End point values
    		 Somatuline Placebo
    Number of subjects analysed
    12
    12
    Units: units
    12
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: NAP

    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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