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   44293   clinical trials with a EudraCT protocol, of which   7350   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:
    A PHASE II/III, MULTI-CENTRE, PROSPECTIVE, EXPLORATORY, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH REFRACTORY DIARRHEA (MEDICAL APPROACH OF REFRACTORY DIARRHEA)

    Summary
    EudraCT number
    2009-009356-20
    Trial protocol
    BE  
    Global end of trial date
    09 Aug 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    27 Feb 2016
    First version publication date
    01 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review and correction.

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    I-48-52030-223
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    IPSEN NV
    Sponsor organisation address
    Guldensporenpark 87, Merelbeke, Belgium, 9820
    Public contact
    Medical Director, Gastroenterology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Gastroenterology, Ipsen, clinical.trials@ipsen.com
    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 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to assess the effect of lanreotide autogel 120 mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.
    Protection of trial subjects
    The Sponsor was responsible for monitoring this data to verify that the rights and well-being of subjects were protected, that trial data were accurate (complete and verifiable to source data) and that the trial was conducted in compliance with the protocol, GCP and regulatory requirements. All measurements and methods used in the study were standard. The QOL questionnaires (SF-36 and IBS) are standardized and validated
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jul 2009
    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: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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
    12
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The study was performed as a multicentre study at 18 investigational sites in Belgium of which 11 recruited patients.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    42 [1]
    Number of subjects completed
    36

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Inclusion/exclusion: 5
    Reason: Number of subjects
    Consent withdrawal: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Worldwide numbers reported are per Treatment, ITT group. However, pre-assignment period is reported per Screened group.
    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Lanreotide Autogel 120 mg
    Arm description
    Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Lanreotides
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg of lanreotide. Open the case containing the prefilled syringe and remove the transparent plastic cover. Remove the needle sheath. Hold the syringe perpendicularly and inject deeply as a subcutaneous injection into the upper outer quadrant of the buttock.

    Number of subjects in period 1
    Lanreotide Autogel 120 mg
    Started
    36
    Completed
    27
    Not completed
    9
         Adverse Event
    2
         Death
    1
         Lost to follow-up
    1
         Lack of efficacy
    5

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    The Safety population was defined as all subjects who received at least one injection of the study medication.

    Reporting group values
    Treatment Total
    Number of subjects
    36 36
    Age categorical
    Units: Subjects
        <30 years
    2 2
        >=30 and <65 years
    22 22
        >=65 years
    12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.2 ( 16.4 ) -
    Gender categorical
    Units: Subjects
        Female
    24 24
        Male
    12 12
    Race
    Units: Subjects
        Caucasian / White
    36 36
    SF36 QOL: Physical Functioning
    SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0–100 scale. There is in addition a single-item measure of Health Transition.
    Units: units on a scale
        arithmetic mean (standard deviation)
    60.5 ( 29.1 ) -
    SF36 QOL: Role Physical
    Units: units on a scale
        arithmetic mean (standard deviation)
    39.6 ( 30.9 ) -
    SF36 QOL: Role Emotional
    Units: units on a scale
        arithmetic mean (standard deviation)
    52.8 ( 38.7 ) -
    SF36 QOL: Vitality
    Units: units on a scale
        arithmetic mean (standard deviation)
    38.8 ( 24.1 ) -
    SF36 QOL: Mental Health
    Units: units on a scale
        arithmetic mean (standard deviation)
    47.6 ( 23.1 ) -
    SF36 QOL: Social Functioning
    Units: units on a scale
        arithmetic mean (standard deviation)
    41.1 ( 31.2 ) -
    SF36 QOL: Bodily Pain
    Units: units on a scale
        arithmetic mean (standard deviation)
    48.7 ( 30.4 ) -
    SF36 QOL: General Health
    Units: units on a scale
        arithmetic mean (standard deviation)
    43.9 ( 22.8 ) -
    IBS QOL: Total Score
    IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items, each with a 5 point response scale. Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL.
    Units: units on a scale
        arithmetic mean (standard deviation)
    47.4 ( 18.5 ) -
    Score of Stool Consistency (Bristol Stool Form Scale)
    Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid
    Units: units on a scale
        median (full range (min-max))
    6 (5 to 7) -
    Mean Number of Stools
    Units: Number of Stools
        arithmetic mean (standard deviation)
    5.5 ( 2.3 ) -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Lanreotide Autogel 120 mg
    Reporting group description
    Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.

    Primary: Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/ 24hours) in the Mean Number of Stools (mean of last 7 days)

    Close Top of page
    End point title
    Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/ 24hours) in the Mean Number of Stools (mean of last 7 days) [1]
    End point description
    Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods].
    End point type
    Primary
    End point timeframe
    Day 28
    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: No statistical analysis derived for primary end point.
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    36
    Units: Percentage of patients
    number (not applicable)
        REDUCTION OF AT LEAST 50% OR NORMALIZATION - Yes
    44.4
        REDUCTION OF AT LEAST 50% OR NORMALIZATION - No
    55.6
    No statistical analyses for this end point

    Secondary: Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS-QOL)} Compared to Baseline

    Close Top of page
    End point title
    Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS-QOL)} Compared to Baseline
    End point description
    SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition. IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL. ITT Population, Analysis based on number (n) of patients with a valid value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    36
    Units: Units on a scale
    arithmetic mean (standard deviation)
        SF36 QOL: Physical Functioning (D21), n=33
    -1.3 ( 20.5 )
        SF36 QOL: Physical Functioning (D28), n=34
    2.4 ( 19.6 )
        SF36 QOL: Physical Functioning (D49), n=26
    2.9 ( 18.9 )
        SF36 QOL: Physical Functioning (D56), n=35
    1.1 ( 23.3 )
        SF36 QOL: Role Physical (D21), n=33
    4.5 ( 19.6 )
        SF36 QOL: Role Physical (D28), n=34
    12.9 ( 21.8 )
        SF36 QOL: Role Physical (D49), n=26
    6.3 ( 28.3 )
        SF36 QOL: Role Physical (D56), n=35
    11.8 ( 23.5 )
        SF36 QOL: Role Emotional (D21), n=33
    -0.3 ( 34.8 )
        SF36 QOL: Role Emotional (D28), n=34
    3.4 ( 40.7 )
        SF36 QOL: Role Emotional (D49), n=25
    7 ( 35.2 )
        SF36 QOL: Role Emotional (D56), n=35
    5 ( 39.6 )
        SF36 QOL: Vitality (D21), n=32
    3.1 ( 22.1 )
        SF36 QOL: Vitality (D28), n=33
    5.9 ( 22.2 )
        SF36 QOL: Vitality (D49), n=24
    2.1 ( 24.6 )
        SF36 QOL: Vitality (D56), n=34
    7.2 ( 23.9 )
        SF36 QOL: Mental Health (D21), n=32
    5.8 ( 27.9 )
        SF36 QOL: Mental Health (D28), n=33
    8.3 ( 28.2 )
        SF36 QOL: Mental Health (D49), n=24
    8.3 ( 27.1 )
        SF36 QOL: Mental Health (D56), n=34
    10.1 ( 27.7 )
        SF36 QOL: Social Functioning (D21), n=31
    9.3 ( 27.8 )
        SF36 QOL: Social Functioning (D28), n=33
    16.7 ( 29.8 )
        SF36 QOL: Social Functioning (D49), n=24
    19.3 ( 34.8 )
        SF36 QOL: Social Functioning (D56), n=33
    14 ( 31.5 )
        SF36 QOL: Bodily Pain (D21), n=33
    -4.6 ( 31.5 )
        SF36 QOL: Bodily Pain (D28), n=34
    8.3 ( 28.6 )
        SF36 QOL: Bodily Pain (D49), n=26
    8.8 ( 29.2 )
        SF36 QOL: Bodily Pain (D56), n=35
    5.3 ( 30.7 )
        SF36 QOL: General Health (D21), n=33
    -2.8 ( 16 )
        SF36 QOL: General Health (D28), n=33
    2.8 ( 16.8 )
        SF36 QOL: General Health (D49), n=26
    4.1 ( 19.1 )
        SF36 QOL: General Health (D56), n=34
    3.7 ( 19.9 )
        IBS QOL: Total Score (D21), n=27
    9.9 ( 21.5 )
        IBS QOL: Total Score (D28), n=26
    13.9 ( 22 )
        IBS QOL: Total Score (D49), n=22
    16.8 ( 22.5 )
        IBS QOL: Total Score (D56), n=29
    16.3 ( 22.5 )
    No statistical analyses for this end point

    Secondary: Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline

    Close Top of page
    End point title
    Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
    End point description
    Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid. ITT Population; Missing number of subjects = 1
    End point type
    Secondary
    End point timeframe
    Baseline (day 1), day 28 and day 56
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    35
    Units: Units on a scale
    median (full range (min-max))
        Change from Baseline to D28 (n=35)
    0 (-3 to 1)
        Change from Baseline to D56 (n=35)
    -0.5 (-4 to 1)
    No statistical analyses for this end point

    Secondary: Percent Change in Mean Number of Stools Compared to Baseline

    Close Top of page
    End point title
    Percent Change in Mean Number of Stools Compared to Baseline
    End point description
    ITT Population; Missing number of subjects = 1
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 28 and Day 56
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    35
    Units: Percent change
    arithmetic mean (standard deviation)
        Change from Baseline at D28 (n=35)
    -25.9 ( 36.7 )
        Change from Baseline at D56 (n=35)
    -30.7 ( 38 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects

    Close Top of page
    End point title
    Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
    End point description
    Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline. ITT Population; Missing number of subjects = 1.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 28 and Day 56.
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    35
    Units: Percentage of days per Week
    arithmetic mean (standard deviation)
        Change from Baseline to D28 (n=35)
    27.5 ( 34.7 )
        Change from Baseline to D56 (n=35)
    33 ( 34.3 )
    No statistical analyses for this end point

    Secondary: Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools

    Close Top of page
    End point title
    Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
    End point description
    ITT Population; Missing number of subjects: 1.
    End point type
    Secondary
    End point timeframe
    Day 56
    End point values
    Lanreotide Autogel 120 mg
    Number of subjects analysed
    35
    Units: Percentage of participants
    number (not applicable)
        Reduction of at least 50% or normalization - Yes
    54.3
        Reduction of at least 50% or normalization - No
    45.7
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 56 (± 2)
    Adverse event reporting additional description
    Treatment Emergent Adverse Event (TEAE)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    -

    Serious adverse events
    Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 36 (13.89%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Steatorrhoea
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal fistula
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypovolaemia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 36 (83.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    4
    Influenza like illness
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    3
    Injection site nodule
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 36 (25.00%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    4
    Steatorrhoea
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2009
    . Trial is phase II/III instead of phase III . Oral contraception is not sufficient in view of the studied disease and should therefore be deleted form the eligibility criteria
    25 Jan 2012
    The main reason for the amendment was to clarify the inclusion criterium 01 and to prolong the inclusion period.

    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
    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 © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA