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    Clinical Trial Results:
    A PHASE II, MULTICENTRE, RANDOMIZED CONTROLLED STUDY EVALUATING THE QUALITY OF LIFE IN PATIENTS WITH INOPERABLE MALIGNANT BOWEL OBSTRUCTION TREATED WITH LANREOTIDE AUTOGEL 120 MG IN COMBINATION WITH STANDARD CARE VS. STANDARD CARE ALONE (QOL IN IMBO STUDY)

    Summary
    EudraCT number
    2013-003176-12
    Trial protocol
    IT  
    Global end of trial date
    16 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jun 2019
    First version publication date
    29 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-93-52030-279
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02365584
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen SpA
    Sponsor organisation address
    Via del Bosco Rinnovato, 6, Milano Fiori Nord, Palazzo U7, Milano, Italy, 20090 Assago
    Public contact
    Medical Director, Ipsen SpA, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen SpA, 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
    16 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the impact on Quality of Life (Edmonton Symptom Assessment System [ESAS] total score) of lanreotide Autogel 120 milligrams (mg) in combination with standard care, in comparison to standard care alone, in patients affected by inoperable malignant bowel obstruction.
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice and in compliance with Independent Ethics Committees / Institutional Review Boards and informed consent regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jan 2015
    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
    Italy: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    29
    From 65 to 84 years
    12
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment to this prospective, randomised, parallel arm, open-label study began on 14 Jan 2015. Patients with a documented diagnosis of inoperable malignant bowel obstruction who had a nasogastric tube (NGT) or presented with ≥ 3 vomiting episodes/day in the last consecutive 48 hours at time of enrolment were recruited to 14 centres in Italy.

    Pre-assignment
    Screening details
    Overall, 43 patients were enrolled and treated in this phase II study. Planned study period duration was 28 days.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Standard Care
    Arm description
    Patients received standard care only according to site clinical practice.
    Arm type
    Standard Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Standard Care + Lanreotide Autogel
    Arm description
    Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Lanreotide Autogel
    Investigational medicinal product code
    Other name
    Somatuline Autogel
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lanreotide Autogel was administered by deep subcutaneous injection in the upper outer quadrant of the buttock. Administration of Lanreotide Autogel was to occur in conjunction with or on the same day of standard care therapy administration. The administrations were supervised by the Investigator, or designee.

    Number of subjects in period 1
    Standard Care Standard Care + Lanreotide Autogel
    Started
    21
    22
    Completed
    9
    8
    Not completed
    12
    14
         Disease Progression
    9
    12
         Adverse event, non-fatal
    2
    2
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard Care
    Reporting group description
    Patients received standard care only according to site clinical practice.

    Reporting group title
    Standard Care + Lanreotide Autogel
    Reporting group description
    Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.

    Reporting group values
    Standard Care Standard Care + Lanreotide Autogel Total
    Number of subjects
    21 22
    Age categorical
    Units: Subjects
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    61.8 ± 9.6 62.8 ± 12.3 -
    Gender categorical
    Units: Subjects
        Female
    14 19 33
        Male
    7 3 10
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian / White
    21 22 43

    End points

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    End points reporting groups
    Reporting group title
    Standard Care
    Reporting group description
    Patients received standard care only according to site clinical practice.

    Reporting group title
    Standard Care + Lanreotide Autogel
    Reporting group description
    Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.

    Primary: Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)

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    End point title
    Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)
    End point description
    Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient’s physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule. Primary endpoint was analysed using the FAS which included all randomised patients who received study therapy, fulfilled the ESAS questionnaire at baseline and had ≥ 5 post-treatment assessments during first 7 days. Mean AUC of ESAS total scores during first 7 days is presented.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    19
    19
    Units: Scores on a scale x time (day)
        least squares mean (standard error)
    179 ± 12.4
    190 ± 12.4
    Statistical analysis title
    ESAS AUC: treatment comparison
    Statistical analysis description
    Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.
    Comparison groups
    Standard Care v Standard Care + Lanreotide Autogel
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.5396
    Method
    ANCOVA
    Parameter type
    Adjusted Least Square Mean Difference
    Point estimate
    -11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -47
         upper limit
    25
    Variability estimate
    Standard error of the mean
    Dispersion value
    17.7
    Notes
    [1] - The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows: • The equality of variances was to verified using the Levene’s test. If it was significant AUC values were to be properly transformed. • The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis. • The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests.

    Secondary: Mean Change From Baseline in ESAS Total Score; FAS

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    End point title
    Mean Change From Baseline in ESAS Total Score; FAS
    End point description
    Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient’s physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition. 'n' in category title indicates number of patients analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    19
    19
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change at Day 7 (n=18, 19)
    -5.1 ± 15.7
    1.9 ± 18.4
        Change at Day 14 (n=16, 14)
    -1.3 ± 21.4
    -7.3 ± 16.7
        Change at Day 28 (n=8, 8)
    -6.8 ± 15.2
    -10.3 ± 16.7
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in ESAS Total Score; Intention To Treat (ITT) Population

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    End point title
    Mean Change From Baseline in ESAS Total Score; Intention To Treat (ITT) Population
    End point description
    Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient’s physical inability. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population (all randomised patients); a positive change indicates a worsening condition. 'n' in category title indicates number of patients analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change at Day 7 (n=18, 20)
    -5.1 ± 15.7
    1.5 ± 18.1
        Change at Day 14 (n=16, 14)
    -1.3 ± 21.4
    -7.3 ± 16.7
        Change at Day 28 (n=8, 8)
    -6.8 ± 15.2
    -10.3 ± 16.7
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population

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    End point title
    Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
    End point description
    Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient’s physical inability. Mean change from baseline of each individual ESAS item score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a positive change indicates a worsening condition. 'n' in category title indicates number of patients analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change at Day 7: Pain (n=18, 20)
    -1.8 ± 3.6
    0.1 ± 3.4
        Change at Day 14: Pain (n=16, 13)
    -1.3 ± 3.6
    -1.9 ± 2.9
        Change at Day 28: Pain (n=7, 6)
    -3.0 ± 3.1
    -1.3 ± 4.2
        Change at Day 7: Activity (n=18, 20)
    -0.3 ± 2.6
    0.7 ± 2.6
        Change at Day 14: Activity (n=16, 13)
    -0.3 ± 3.3
    -0.7 ± 3.0
        Change at Day 28: Activity (n=7, 6)
    -1.4 ± 2.8
    -0.3 ± 3.2
        Change at Day 7: Nausea (n=18, 20)
    0.5 ± 3.2
    0.9 ± 3.2
        Change at Day 14: Nausea (n=16, 13)
    0.1 ± 3.8
    0.5 ± 4.1
        Change at Day 28: Nausea (n=7, 6)
    -0.6 ± 4.6
    0.0 ± 3.9
        Change at Day 7: Depression (n=18, 20)
    -1.8 ± 3.5
    -1.1 ± 3.7
        Change at Day 14 Depression (n=16, 13)
    -1.9 ± 3.5
    -2.4 ± 3.2
        Change at Day 28: Depression (n=7, 6)
    -2.6 ± 1.9
    -3.7 ± 4.0
        Change at Day 7: Anxiety (n=18, 20)
    0.0 ± 2.7
    -0.2 ± 3.2
        Change at Day 14: Anxiety (n=16, 13)
    0.4 ± 3.3
    -2.7 ± 3.8
        Change at Day 28: Anxiety (n=7, 6)
    -1.1 ± 1.9
    -1.5 ± 1.0
        Change at Day 7: Drowsiness (n=18, 20)
    -0.7 ± 2.7
    0.4 ± 3.1
        Change at Day 14: Drowsiness (n=16, 13)
    -0.1 ± 3.5
    -0.6 ± 2.6
        Change at Day 28: Drowsiness (n=7, 6)
    -1.9 ± 3.1
    -1.5 ± 1.5
        Change at Day 7: Appetite (n=18, 20)
    -0.2 ± 3.1
    0.5 ± 3.2
        Change at Day 14: Appetite (n=16, 13)
    0.9 ± 3.0
    0.4 ± 3.9
        Change at Day 28: Appetite (n=7, 6)
    0.4 ± 3.1
    -2.0 ± 2.3
        Change at Day 7: Well-being (n=18, 20)
    -0.8 ± 2.6
    -0.4 ± 3.1
        Change at Day 14: Well-being (n=16, 13)
    0.4 ± 2.5
    -0.5 ± 4.3
        Change at Day 28: Well-being (n=7, 6)
    0.4 ± 2.4
    -2.3 ± 2.9
        Change at Day 7: Shortness of breath (n=18, 20)
    -0.1 ± 2.3
    0.7 ± 2.6
        Change at Day 14: Shortness of breath (n=16, 13)
    0.6 ± 3.4
    0.7 ± 2.9
        Change at Day 28: Shortness of breath (n=7, 6)
    -0.4 ± 2.0
    -0.2 ± 3.8
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population

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    End point title
    Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
    End point description
    The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient’s medical file at each study visit (Days 1, 7, 14 and 28). Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition. 'n' in category title indicates number of patients analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change at Day 7 (n=18, 19)
    -2.8 ± 12.3
    -3.7 ± 6.8
        Change at Day 14 (n=16, 13)
    -5.6 ± 11.5
    -5.4 ± 12.7
        Change at Day 28 (n=8, 7)
    -5.0 ± 16.0
    -7.1 ± 20.6
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population

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    End point title
    Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
    End point description
    Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a positive change indicates a worsening condition. 'n' in category title indicates number of patients analysed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Change at Day 7 (n=19, 19)
    -22.0 ± 32.5
    -9.6 ± 30.8
        Change at Day 14 (n=16, 14)
    -15.6 ± 34.9
    -27.7 ± 28.8
        Change at Day 28 (n=7, 7)
    -32.0 ± 31.5
    -17.0 ± 34.9
    No statistical analyses for this end point

    Secondary: Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT

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    End point title
    Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
    End point description
    Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented for the ITT population (all randomised patients). Number of patients without NGT for each of the specified time points is also presented. Patients without NGT were defined as patients without the insertion of NGT for the whole study period.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Participants
        From Day 1 to Day 7: ≤ 2 vomiting episodes/day
    5
    4
        From Day 1 to Day 7: patients without NGT
    6
    8
        From Day 1 to Day 14: ≤ 2 vomiting episodes/day
    4
    4
        From Day 1 to Day 14: patients without NGT
    5
    7
        From Day 1 to Day 28: ≤ 2 vomiting episodes/day
    4
    4
        From Day 1 to Day 28: patients without NGT
    5
    7
    No statistical analyses for this end point

    Secondary: Mean Daily NGT Secretion Volume, in Patients With a NGT

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    End point title
    Mean Daily NGT Secretion Volume, in Patients With a NGT
    End point description
    NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. Mean daily secretion volumes, in patients with NGT, is presented. Only in patients with NGT were included in the analysis (Standard Care arm: n=11, 15, 16 and 16 at Baseline, Days 7, 14 and 28, respectively; Standard Care + Lanreotide Autogel arm: n=14, 14, 15 and 15 at Baseline, Days 7, 14 and 28, respectively). 'n' in category title indicates number of patients with data available for analysis at each time point; 999999 denotes a data value as non-calculable.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: millilitres
    arithmetic mean (standard deviation)
        Baseline (n=1, 2)
    200.0 ± 999999
    700.0 ± 141.4
        Day 7 (n=4, 2)
    4875.0 ± 4023.6
    1025.0 ± 813.2
        Day 14 (n=2, 6)
    12675.0 ± 2863.8
    7090.8 ± 2433.9
        Day 28 (n=10, 7)
    27501.0 ± 27081.8
    18301.4 ± 11657.9
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population

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    End point title
    Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
    End point description
    Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. Mean change from baseline in number of daily vomiting episodes for the periods Day 1 to Day 7, Day 1 to Day 14 and Day 1 to Day 28 is presented for the ITT population (all randomised patients). 'n' in category title indicates number of patients with data available for analysis at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Episodes (daily)
    arithmetic mean (standard deviation)
        Change Day 1 to Day 7 (n=21, 20)
    5.7 ± 6.2
    6.0 ± 9.9
        Change Day 1 to Day 14 (n=21, 20)
    10.6 ± 12.7
    10.4 ± 15.8
        Change Day 1 to Day 28 (n=21, 20)
    16.5 ± 19.9
    14.1 ± 20.2
    No statistical analyses for this end point

    Secondary: Assessment of Passage of Stools; ITT Population

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    End point title
    Assessment of Passage of Stools; ITT Population
    End point description
    Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. The ITT population included all randomised patients.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1, before randomisation) to Day 28.
    End point values
    Standard Care Standard Care + Lanreotide Autogel
    Number of subjects analysed
    21
    22
    Units: Subjects
        Day 1: Yes
    2
    2
        Day 1: No
    19
    20
        Day 2: Yes
    6
    3
        Day 2: No
    13
    16
        Day 3: Yes
    4
    3
        Day 3: No
    15
    17
        Day 4: Yes
    4
    2
        Day 4: No
    15
    18
        Day 5: Yes
    6
    3
        Day 5: No
    13
    17
        Day 6: Yes
    4
    2
        Day 6: No
    15
    17
        Day 7: Yes
    3
    3
        Day 7: No
    16
    16
        Day 8: Yes
    6
    3
        Day 8: No
    12
    17
        Day 9: Yes
    4
    5
        Day 9: No
    13
    14
        Day 10: Yes
    3
    1
        Day 10: No
    13
    15
        Day 11: Yes
    5
    1
        Day 11: No
    10
    14
        Day 12: Yes
    4
    1
        Day 12: No
    11
    11
        Day 13: Yes
    3
    1
        Day 13: No
    12
    13
        Day 14: Yes
    5
    1
        Day 14: No
    10
    14
        Day 15: Yes
    2
    2
        Day 15: No
    12
    10
        Day 16: Yes
    3
    2
        Day 16: No
    11
    9
        Day 17: Yes
    2
    3
        Day 17: No
    12
    9
        Day 18: Yes
    3
    2
        Day 18: No
    11
    8
        Day 19: Yes
    3
    2
        Day 19: No
    8
    8
        Day 20: Yes
    2
    2
        Day 20: No
    9
    8
        Day 21: Yes
    2
    2
        Day 21: No
    9
    7
        Day 22: Yes
    2
    2
        Day 22: No
    9
    6
        Day 23: Yes
    3
    2
        Day 23: No
    7
    5
        Day 24: Yes
    3
    2
        Day 24: No
    7
    6
        Day 25: Yes
    2
    2
        Day 25: No
    7
    5
        Day 26: Yes
    2
    2
        Day 26: No
    6
    6
        Day 27: Yes
    1
    2
        Day 27: No
    7
    4
        Day 28: Yes
    3
    2
        Day 28: No
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (Day 1) until end of study (Day 28).
    Adverse event reporting additional description
    Treatment emergent adverse events are reported for the safety population which included all patients who received at least one dose of study therapy.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Standard Care
    Reporting group description
    Patients received standard care only according to site clinical practice.

    Reporting group title
    Standard Care + Lanreotide Autogel
    Reporting group description
    Patients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.

    Serious adverse events
    Standard Care Standard Care + Lanreotide Autogel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 22 (9.09%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    2
    2
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Standard Care Standard Care + Lanreotide Autogel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 21 (23.81%)
    5 / 22 (22.73%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2

    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.
    The study was terminated early due to insufficient recruitment. As a consequence, the results of the analyses should be interpreted cautiously and no conclusions should be made.
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