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    Clinical Trial Results:
    A PHASE IV, OPEN-LABEL, RANDOMISED, CROSS-OVER STUDY TO ASSESS PATIENT PREFERENCE AND HEALTH ECONOMY IN PATIENTS WITH NEUROENDOCRINE TUMOURS, TREATED WITH LANREOTIDE AUTOGEL GIVEN AS SELF ADMINISTRATION

    Summary
    EudraCT number
    2007-006514-42
    Trial protocol
    SE   DK  
    Global end of trial date
    16 Aug 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Mar 2016
    First version publication date
    11 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-99-52030-216
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen AB
    Sponsor organisation address
    Kista Science Tower, Farogatan 33,, Kista, Sweden, 164 51
    Public contact
    Medical Director, Endocrinology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Endocrinology, 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
    27 Jul 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Aug 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the patient preference of two lanreotide Autogel administration practices; self/partner or healthcare professional administration.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Jun 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
    Norway: 4
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    Denmark: 7
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    14
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 94 patients were entered on the screening and recruitment logs of all 10 participating sites. Date of first enrolment: 13 June 2008.

    Pre-assignment
    Screening details
    Out of 94 patients, 62 patients were offered participation. 32 were not eligible and 36 patients were chose not to participate mainly due to lack of motivation, satisfaction with current form of administration or fear of self-injection. 26 patients at nine sites entered the study of which 23 completed the study and 3 withdrew prematurely.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sequence Group 1 (Self-HCP): lanreotide Autogel
    Arm description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home.
    Arm type
    Experimental

    Investigational medicinal product name
    lanreotide Autogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study drug administered was lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection either in the upper external quadrant of the buttock or in the upper outer thigh.

    Arm title
    Sequence Group 2 (HCP-Self): lanreotide Autogel
    Arm description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities.
    Arm type
    Experimental

    Investigational medicinal product name
    lanreotide Autogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The study drug administered was lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection either in the upper external quadrant of the buttock or in the upper outer thigh.

    Number of subjects in period 1
    Sequence Group 1 (Self-HCP): lanreotide Autogel Sequence Group 2 (HCP-Self): lanreotide Autogel
    Started
    11
    15
    Completed
    10
    13
    Not completed
    1
    2
         Patient died
    -
    1
         Adverse event
    -
    1
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence Group 1 (Self-HCP): lanreotide Autogel
    Reporting group description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home.

    Reporting group title
    Sequence Group 2 (HCP-Self): lanreotide Autogel
    Reporting group description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities.

    Reporting group values
    Sequence Group 1 (Self-HCP): lanreotide Autogel Sequence Group 2 (HCP-Self): lanreotide Autogel Total
    Number of subjects
    11 15 26
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    6 8 14
        From 65-84 years
    5 7 12
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.2 ± 6.5 60 ± 12.7 -
    Gender categorical
    Units: Subjects
        Female
    4 8 12
        Male
    7 7 14
    Number of patients per country
    Units: Subjects
        Denmark
    3 4 7
        Norway
    1 3 4
        Sweden
    7 8 15

    End points

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    End points reporting groups
    Reporting group title
    Sequence Group 1 (Self-HCP): lanreotide Autogel
    Reporting group description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home.

    Reporting group title
    Sequence Group 2 (HCP-Self): lanreotide Autogel
    Reporting group description
    lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities.

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomised patients with at least one dose of study medication and with a preference assessment recorded.

    Subject analysis set title
    Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Baseline refers to the last non-study visit at the clinic.

    Subject analysis set title
    Group 1 Self or Partner First Then HCP Administration
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Self or Partner Administration followed by HCP Administration.

    Subject analysis set title
    Group 2 HCP Then Self or Partner Administration
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Administration by HCP then Self or Partner Administration.

    Subject analysis set title
    Training Period
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.

    Subject analysis set title
    Self or Partner Administration
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.

    Subject analysis set title
    HCP Administration
    Subject analysis set type
    Full analysis
    Subject analysis set description
    A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.

    Primary: Subject Preference for Self or Partner Administration

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    End point title
    Subject Preference for Self or Partner Administration [1]
    End point description
    A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
    End point type
    Primary
    End point timeframe
    Between week 30 to 34
    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 provided for Subject Preference for Self or Partner Administration
    End point values
    Group 1 Self or Partner First Then HCP Administration Group 2 HCP Then Self or Partner Administration
    Number of subjects analysed
    11
    14
    Units: Participants
        Proportion preferring Self-partner Administration
    10
    12
    No statistical analyses for this end point

    Secondary: Number of Patients Stating at Least One Injection Interfered With Daily Activities

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    End point title
    Number of Patients Stating at Least One Injection Interfered With Daily Activities
    End point description
    The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'. Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
    End point type
    Secondary
    End point timeframe
    Between baseline to week 32, after each injection (8-9 injections).
    End point values
    Training Period Self or Partner Administration HCP Administration
    Number of subjects analysed
    25
    25
    25
    Units: participants
        Patients with atleast 1 Injection Interference
    6
    2
    6
    No statistical analyses for this end point

    Secondary: Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing

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    End point title
    Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
    End point description
    The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?' Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded. -vely = Negatively, inj = Injection
    End point type
    Secondary
    End point timeframe
    Between baseline to week 32, after each injection (8-9 injections)
    End point values
    Training Period Self or Partner Administration HCP Administration
    Number of subjects analysed
    25
    25
    25
    Units: participants
        Patients Stating at Least One Inj -vely Interfered
    4
    2
    1
    No statistical analyses for this end point

    Secondary: Days Sick Leave

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    End point title
    Days Sick Leave
    End point description
    Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6). Safety population: all randomized subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.
    End point type
    Secondary
    End point timeframe
    Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration).
    End point values
    Self or Partner Administration HCP Administration
    Number of subjects analysed
    6
    6
    Units: days
    23
    0
    No statistical analyses for this end point

    Secondary: Total Number of Visits to HCP Due to Carcinoid Symptoms

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    End point title
    Total Number of Visits to HCP Due to Carcinoid Symptoms
    End point description
    Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms. Safety population: all randomized subjects with at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration).
    End point values
    Self or Partner Administration HCP Administration
    Number of subjects analysed
    12
    12
    Units: visits
    17
    25
    No statistical analyses for this end point

    Secondary: Perceived Symptom Control Evaluation in Respect to Episodes of Flushing

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    End point title
    Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
    End point description
    Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol. Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
    End point type
    Secondary
    End point timeframe
    Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).
    End point values
    Baseline Self or Partner Administration HCP Administration
    Number of subjects analysed
    25
    25
    25
    Units: participants
        Worsened
    0
    1
    1
        Similar
    24
    21
    20
        Improved
    1
    2
    4
        Missing
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea

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    End point title
    Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
    End point description
    Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol. Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
    End point type
    Secondary
    End point timeframe
    Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).
    End point values
    Baseline Self or Partner Administration HCP Administration
    Number of subjects analysed
    25
    25
    25
    Units: participants
        Worsened
    1
    4
    0
        Similar
    22
    17
    24
        Improved
    2
    3
    1
        Missing
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Chromogranin A Levels

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    End point title
    Chromogranin A Levels
    End point description
    Biochemical control was assessed by analyzing chromogranin A levels at each site visit, which was mandatory for all subjects. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2. ITT population that had hormone levels assessed at each administration block.
    End point type
    Secondary
    End point timeframe
    Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
    End point values
    ITT
    Number of subjects analysed
    22
    Units: nmol/l
    arithmetic mean (standard deviation)
        Before Self or Partner Administration
    37.48 ± 58.35
        After Self or Partner Administration
    47.85 ± 74.89
        Before HCP Administration
    42.05 ± 70.74
        After HCP Administration
    37.42 ± 57.96
    No statistical analyses for this end point

    Secondary: 5-hydroxyindoleacetic Acid (5-HIAA) Levels

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    End point title
    5-hydroxyindoleacetic Acid (5-HIAA) Levels
    End point description
    Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2. 5-HIAA were assessed as judged necessary by the investigator at each site.
    End point type
    Secondary
    End point timeframe
    Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
    End point values
    ITT
    Number of subjects analysed
    12
    Units: nmol/l
    arithmetic mean (standard deviation)
        Before Self or Partner Administration
    220.17 ± 238.32
        After Self or Partner Administration
    219.17 ± 227.64
        Before HCP Administration
    217.08 ± 244.32
        After HCP Administration
    219.58 ± 218.51
    No statistical analyses for this end point

    Secondary: Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method

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    End point title
    Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
    End point description
    Assessed by the number of HCP with a positive response 'yes' to two questions: 1.Based on your experience during this trial, did you feel confident in the safety of your patients? 2.Based on your experience during this trial, would you recommend suitable patients to try self or partner administration? One HCP from each site who enrolled participants replied to the question and the method used is Self or Partner Administration Method.
    End point type
    Secondary
    End point timeframe
    Between week 30 to 34.
    End point values
    ITT
    Number of subjects analysed
    9
    Units: participants
        HCP With +ve Response to Specified Questions
    9
    No statistical analyses for this end point

    Secondary: Telephone Contacts with Study Site Staff

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    End point title
    Telephone Contacts with Study Site Staff
    End point description
    Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the time, taken for telephone contacts with study site staff.
    End point type
    Secondary
    End point timeframe
    Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration).
    End point values
    Self or Partner Administration HCP Administration
    Number of subjects analysed
    25
    25
    Units: Minutes
        Time spent for telephone contacts with Study staff
    205
    312
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to visit 3
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Training Period
    Reporting group description
    The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.

    Reporting group title
    Self or Partner Administration
    Reporting group description
    The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.

    Reporting group title
    HCP Administration
    Reporting group description
    A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.

    Serious adverse events
    Training Period Self or Partner Administration HCP Administration
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 26 (15.38%)
    3 / 26 (11.54%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Injury, poisoning and procedural complications
    Post procedural fistula
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Disease progression
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Biliary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Training Period Self or Partner Administration HCP Administration
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 26 (26.92%)
    4 / 26 (15.38%)
    7 / 26 (26.92%)
    Vascular disorders
    Flushing
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    2
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    4
    1
    0
    General disorders and administration site conditions
    Disease progression
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    2
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 26 (3.85%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    6
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    4
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2008
    Local Danish Amendment: In Denmark, the following changes were made to the initial protocol following a request from the Ethics Committee in Region Midtjylland: • A section to describe how the patients were recruited into the study was added. • A section to describe potential risks and side effects were added. • A section to describe the ethical aspects of the study was added. • An appendix to define the financial situation was added, including details of who initiated the study, who the sponsor is, details of the financial agreement and information regarding the financial relationship between the Principal Investigator (PI) in Denmark and the sponsor. • A section to clearly state that all results, whether positive or negative will be published was added. • A more detailed section regarding the Informed Consent process was added.
    13 Mar 2008
    Amendment 1: In amendment 1, dated 13 March 2008, the following changes were made to the initial protocol: • Patients with previous experience of self and/or partner-administered lanreotide Autogel should not be allowed to participate in the study due to the risk of receiving biased data. • An inconsistency concerning the time between Visit 1 and 2 for Group 1 was corrected to 20-24 weeks throughout the protocol. • The randomisation process was incorporated into the eCRF instead of being performed manually by the Clinical Study Coordinator at Ipsen. This change was made to minimise the risk of human randomisation errors, as well as to increase the availability. • Patient initials were removed from the patient coding process. Only patient number was used as patient identification. Amendment 1 was submitted to all participating countries after initial approval.
    12 Nov 2008
    Amendment 2: In amendment 2, dated 12 November 2008, the following changes were made to the protocol: • A misprint of the emergency phone number on the cover page was corrected. • The recruitment period was extended by 6 months, from 6 to 12 months in order to reach the inclusion target. • The maximum number of patients allowed per site was increased from 5 to 10 patients to allow high-recruiting sites to include more than 5 patients. • The responsibility for data entry of laboratory values was transferred from study personnel to central laboratory personnel. Amendment 2 was submitted to Swedish and Norwegian regulatory authorities and Ethics Committees in Nov/Dec 2008. A modified version of amendment 2 was submitted to Danish regulatory authorities and Ethics Committees in April 2009 as local Danish amendment 2.
    06 Apr 2009
    Local Danish Amendment 2: In local Danish amendment 2, dated 06 April 2009, the following changes were made to the protocol: • A misprint of the emergency phone number on the cover page was corrected. • Recruitment period was extended by 12 months, from 6 to 18 months. • Maximum number of patients allowed per site was increased from 5 to 10 patients. • Compensation to high-recruiting sites was increased to compensate for time spent pre-screening patients. Local Danish amendment 2 was submitted to Danish authorities as stated above.
    29 Jan 2010
    Amendment 3: The following changes were made to the protocol: • The number of patients required for inclusion was reduced from 42 to 26 due to slow recruitment and a higher proportion of patients preferring self-partner administration compared to the value used in sample size calculations. Amendment 3 was submitted to regulatory authorities and ethics committees in all participating countries.

    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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