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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

    Summary
    EudraCT number
    		 2008-000643-34
    Trial protocol
    		 BE  
    Global end of trial date
    15 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2021
    First version publication date
    04 Feb 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Som-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    herestraat 49, Leuven, Belgium, 3000
    Public contact
    lieselot Holvoet, uzleuven, lieselot.holvoet@uzleuven.be
    Scientific contact
    jan tack, uzleuven, jan.tack@uzleuven.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
    11 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Somatuline 90 mg versus placebo in the treatment of dumping syndrome by using a specific Treatment Assessment Scale and a specific dumping score.
    Protection of trial subjects
    nothing in particular
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jul 2008
    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)
    22
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 patients fulfilling inclusion/exclusion criteria were recruited

    Pre-assignment
    Screening details
    		 In total, 33 patients were assessed for eligibility, with nine screening failures (three with gallstones, three previous exposure to OCT, one diabetes mellitus, one pregnancy and one with DS <10), resulting in 24 patients included and randomised in the trial (12 to LAN and 12 placebo first;

    Period 1
    Period 1 title
    overall period (cross over trial)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 treatment order LAN - placebo
    Arm description
    		 patient started with active treatment = lanreotide during first treatment period. Before cross over pt was treated with active treatment (=LAN). After wash out (5 weeks) and cross over, pt was treated with placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    lanreotide autogel 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    prefilled syringe. Deep SC every 4 weeks during 3 months = 3 injections/treatment period. deep SC injection.

    Investigational medicinal product name
    placebo (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    prefilled syringe. Deep SC every 4 weeks during 3 months = 3 injections/treatment period.

    Arm title
    		 treatment order placebo -LAN
    Arm description
    		 patient started with placebo treatment = placebo during first treatment period. Before cross over pt was treated with placebo. After wash out (5 weeks) and cross over, pt was treated with active treatment (=LAN)
    Arm type
    		 Experimental

    Investigational medicinal product name
    lanreotide autogel 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Prefilled syringe. Deep SC every 4 weeks during 3 months = 3 injections/treatment period. deep SC injection.

    Investigational medicinal product name
    placebo (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    prefilled syringe. Deep SC every 4 weeks during 3 months = 3 injections/treatment period.

    Number of subjects in period 1
    		treatment order LAN - placebo treatment order placebo -LAN
    Started
    12
    12
    wash out period
    9
    12
    Completed
    8
    9
    Not completed
    4
    3
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    treatment order LAN - placebo
    Reporting group description
    		 patient started with active treatment = lanreotide during first treatment period. Before cross over pt was treated with active treatment (=LAN). After wash out (5 weeks) and cross over, pt was treated with placebo

    Reporting group title
    treatment order placebo -LAN
    Reporting group description
    		 patient started with placebo treatment = placebo during first treatment period. Before cross over pt was treated with placebo. After wash out (5 weeks) and cross over, pt was treated with active treatment (=LAN)

    Reporting group values
    		 treatment order LAN - placebo treatment order placebo -LAN Total
    Number of subjects
    		 12 12 24
    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
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 48 (45 to 52) 47 (36 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 6 10 16
        Male
    		 6 2 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    treatment order LAN - placebo
    Reporting group description
    		 patient started with active treatment = lanreotide during first treatment period. Before cross over pt was treated with active treatment (=LAN). After wash out (5 weeks) and cross over, pt was treated with placebo

    Reporting group title
    treatment order placebo -LAN
    Reporting group description
    		 patient started with placebo treatment = placebo during first treatment period. Before cross over pt was treated with placebo. After wash out (5 weeks) and cross over, pt was treated with active treatment (=LAN)

    Primary: dumping score

    		 Close Top of page
    End point title
    		 dumping score
    End point description
    Total DS is calculated as the sum of eight early and six late dumping symptoms, as described by Arts et al. (Clin Gastroenterol Hepatol 2009; 7: 432–437).Early dumping symptoms include sweating, flushes, dizziness, palpitations, abdominal pain, diarrhoea, bloating and nausea occurring within one hour after a meal. Late dumping symptoms include sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression occurring an hour or more after a meal. Symptoms were cored using a four-point Likert scale (0 none, 1 mild, 2 moderate or 3 severe). Pooled total DS before (week 0) and after (week 11) each treatment were compared within and between groups.
    End point type
    Primary
    End point timeframe
    week 11 after start of randomized treatment
    End point values
    		 treatment order LAN - placebo treatment order placebo -LAN
    Number of subjects analysed
    8 [1]
    9 [2]
    Units: symptom score
        number (not applicable)
    8
    9
    Notes
    [1] - Cross-over trial; for subject number details: see publication
    [2] - see comment for group 1
    Statistical analysis title
    		 Dumping score after 11 weeks
    Statistical analysis description
    Dumping severity score, sum of individual symptoms, compared after 11 weeks in each treatment group
    Comparison groups
    treatment order LAN - placebo v treatment order placebo -LAN
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.21 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - LAN versus placebo. This is a cross-over trial. All patients received both study treatments
    [4] - between-group comparison not significant at this sample size.

    Adverse events

    		 Close Top of page
    Adverse events information
    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
    0
    Reporting groups
    Reporting group title
    LAN treatment
    Reporting group description
    		 -

    Reporting group title
    placebo treatment
    Reporting group description
    		 -

    Serious adverse events
    		 LAN treatment placebo treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    epilepsia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    hypoglycemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LAN treatment placebo treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 24 (91.67%)
    16 / 21 (76.19%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 24 (50.00%)
    6 / 21 (28.57%)
         occurrences all number
    12
    6
    Endocrine disorders
    hypoglycemia
         subjects affected / exposed
    5 / 24 (20.83%)
    5 / 21 (23.81%)
         occurrences all number
    5
    5
    Infections and infestations
    Infection
         subjects affected / exposed
    5 / 24 (20.83%)
    9 / 21 (42.86%)
         occurrences all number
    5
    9

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31662863
    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-Sat Apr 27 23:42:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA