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    Clinical Trial Results:
    A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

    Summary
    EudraCT number
    2012-001680-72
    Trial protocol
    HU   PT   BE   IT  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Mar 2016
    First version publication date
    15 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-390MR_206
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01642602
    WHO universal trial number (UTN)
    U1111-1128-5977
    Sponsors
    Sponsor organisation name
    Takeda Development Centre Europe Ltd.
    Sponsor organisation address
    61 Aldwych, London, United Kingdom, WC2B 4AE
    Public contact
    Program Manager, Takeda Development Centre Europe Ltd., 0044 20 3116 8000, clinicaloperations@tgrd.com
    Scientific contact
    Program Manager, Takeda Development Centre Europe Ltd., 0044 20 3116 8000, clinicaloperations@tgrd.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
    21 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux Disease (GERD).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Jun 2012
    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
    Poland: 7
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    United States: 66
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Brazil: 2
    Worldwide total number of subjects
    104
    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)
    104
    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
    Participants took part in the study at 36 sites in the United States, Belgium, Hungary, Italy, Poland, Portugal, Brazil, and Mexico from 22 June 2012 to 21 January 2014.

    Pre-assignment
    Screening details
    Adolescent subjects (male or female), aged 12 to 17 years (inclusive) with symptomatic non-erosive gastrointestinal reflux disease were enrolled in 1 group and received dexlansoprazole 30 mg orally once a day for 4 weeks.

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

    Arms
    Arm title
    Dexlansoprazole 30 mg
    Arm description
    Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Dexlansoprazole
    Investigational medicinal product code
    Other name
    Dexilant
    Pharmaceutical forms
    Prolonged-release capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dexlansoprazole delayed-release capsules.

    Number of subjects in period 1
    Dexlansoprazole 30 mg
    Started
    104
    Completed
    102
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dexlansoprazole 30 mg
    Reporting group description
    Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

    Reporting group values
    Dexlansoprazole 30 mg Total
    Number of subjects
    104 104
    Age categorical
    Units: Subjects
        12-14 years
    34 34
        15-17 years
    70 70
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15 ± 1.5 -
    Gender categorical
    Units: Subjects
        Female
    73 73
        Male
    31 31
    Race/Ethnicity
    Units: Subjects
        Black or African American
    0 0
        White
    0 0
        Multiracial
    0 0
        Hispanic or Latino
    19 19
        Non-Hispanic and Latino
    47 47
        Not Collected
    38 38
    Smoking Classification
    Units: Subjects
        Never Smoked
    103 103
        Ex-smoker
    1 1
    H pylori Status
    Units: Subjects
        Positive
    14 14
        Negative
    90 90
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    61.6 ± 14.393 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    163.1 ± 7.58 -
    Body mass index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    23.02 ± 4.434 -

    End points

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    End points reporting groups
    Reporting group title
    Dexlansoprazole 30 mg
    Reporting group description
    Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.

    Primary: Percent of Participants who Experience Each Treatment Emergent Adverse Event experienced by ≥5% of participants while receiving dexlansoprazole during the 4 week Treatment Period

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    End point title
    Percent of Participants who Experience Each Treatment Emergent Adverse Event experienced by ≥5% of participants while receiving dexlansoprazole during the 4 week Treatment Period [1]
    End point description
    A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.
    End point type
    Primary
    End point timeframe
    4 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: No statistical analysis was performed as there is only 1 reporting group.
    End point values
    Dexlansoprazole 30 mg
    Number of subjects analysed
    104
    Units: Participants
    number (not applicable)
        Diarrhoea
    6.7
        Headache
    6.7
    No statistical analyses for this end point

    Secondary: The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment

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    End point title
    The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment
    End point description
    Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    Dexlansoprazole 30 mg
    Number of subjects analysed
    104
    Units: Days
        median (full range (min-max))
    47.3 (0 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Dexlansoprazole 30 mg
    Reporting group description
    Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

    Serious adverse events
    Dexlansoprazole 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Dexlansoprazole 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 104 (13.46%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 104 (6.73%)
         occurrences all number
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 104 (6.73%)
         occurrences all number
    7

    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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