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    Clinical Trial Results:
    A Multicenter, Open-Label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Pediatric Subjects Aged 5 to 17 Years, Inclusive

    Summary
    EudraCT number
    2011-003742-40
    Trial protocol
    DE  
    Global end of trial date
    13 Feb 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    09 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9422C00002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, 431 83
    Public contact
    Tore Persson, AstraZeneca R&D, +46 31 7766069, tore.teb.persson@astrazeneca.com
    Scientific contact
    Stefan Eklund, MD, AstraZeneca R&D, Mölndal, +46 31 7762557, Stefan.Eklund@astrazeneca.co
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to investigate the safety of Entocort™ EC in a pediatric mild-to-moderate Crohn’s disease population for the maintenance of clinical remission.
    Protection of trial subjects
    Subjects could discontinue IP and assessments at any time at the discretion of the investigator. Subjects were also free to withdraw from the study at any time, without prejudice to further treatment. Specific reasons for withdrawal of a subject from this study and the procedures to be followed when a subject was withdrawn are listed in the CSP. For subjects who were discontinued, the subjects and parents/guardians of the subject were asked about the reasons for their discontinuation and about the presence of any Adverse events (AEs). If possible, they were seen and underwent final assessment by the investigator. Adverse events were followed, and any IPs and study materials were returned by the subject/parents/guardians.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    European Union: 27
    Worldwide total number of subjects
    55
    EEA total number of subjects
    0
    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)
    7
    Adolescents (12-17 years)
    48
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects could enter this study from the pediatric Entocort induction protocol (D9442C00001) but this was not mandatory. If subjects fulfilled the eligibility criteria as stated and were in Crohn’s disease clinical remission, they could enter this study.

    Pre-assignment
    Screening details
    Subjects could enter this study from the pediatric Entocort induction protocol (D9442C00001) but this was not mandatory. If subjects fulfilled the eligibility criteria as stated and were in Crohn’s disease clinical remission, they could enter this study.

    Period 1
    Period 1 title
    Full study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    Entocort
    Arm description
    Entocort EC 6 mg/day for 8 weeks, then 3 mg/day for 2 weeks, then no drug for 2 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Entocort EC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg/day

    Number of subjects in period 1
    Entocort
    Started
    50
    Completed
    41
    Not completed
    9
         Protocol deviation
    1
         1 study specific, 1 not specified
    2
         Lack of efficacy
    3
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Full study
    Reporting group description
    -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 55 patients were screened/enrolled, but only 50 of them met the inclusion/exclusion criteria; all analyses are based on these 50.
    Reporting group values
    Full study Total
    Number of subjects
    50 50
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    7 7
        Adolescents (12-17 years)
    43 43
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous
    Age in years
    Units: years
        median (full range (min-max))
    15 (8 to 17) -
    Gender Categorical
    Units: Subjects
        Female
    20 20
        Male
    30 30
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set consisted of all subjects who took at least 1 dose of Entocort™ EC.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS consisted of all subjects included in the safety analysis set who had a complete post baseline (Visit 4) data for PCDAI assessment.

    Subject analysis sets values
    Safety analysis set Full analysis set (FAS)
    Number of subjects
    50
    49
    Age Categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    7
    6
        Adolescents (12-17 years)
    43
    43
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age Continuous
    Age in years
    Units: years
        median (full range (min-max))
    15 (8 to 17)
    15 (8 to 17)
    Gender Categorical
    Units: Subjects
        Female
    20
    20
        Male
    30
    29

    End points

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    End points reporting groups
    Reporting group title
    Entocort
    Reporting group description
    Entocort EC 6 mg/day for 8 weeks, then 3 mg/day for 2 weeks, then no drug for 2 weeks

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set consisted of all subjects who took at least 1 dose of Entocort™ EC.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS consisted of all subjects included in the safety analysis set who had a complete post baseline (Visit 4) data for PCDAI assessment.

    Primary: Patients with adverse events

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    End point title
    Patients with adverse events [1]
    End point description
    Did the patient have an adverse event?
    End point type
    Primary
    End point timeframe
    12 weeks
    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: Since this study only had one arm, only descriptive statistics has been used. No comparisons, no statistical tests and no confidence intervals.
    End point values
    Safety analysis set
    Number of subjects analysed
    50
    Units: Patient
    37
    No statistical analyses for this end point

    Secondary: Change in PCDAI

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    End point title
    Change in PCDAI
    End point description
    Pediatric Crohn’s disease activity index
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Full analysis set (FAS)
    Number of subjects analysed
    49
    Units: Units on a scale
        arithmetic mean (standard deviation)
    2 ± 7
    No statistical analyses for this end point

    Secondary: Change in IMPACT III

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    End point title
    Change in IMPACT III
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Safety analysis set
    Number of subjects analysed
    49
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.2 ± 8.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    -

    Serious adverse events
    Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 50 (8.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Ileal obstruction
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal ulceration and perforation
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 50 (72.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Psychiatric disorders
    Mood swings
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 50 (16.00%)
         occurrences all number
    11
    Crohn's disease
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Haematochizia
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 50 (12.00%)
         occurrences all number
    6
    Hirsutism
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Increased appetite
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Gastroenteritis viral
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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