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    Clinical Trial Results:
    A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive

    Summary
    EudraCT number
    		 2004-002370-39
    Trial protocol
    		 IT   Outside EU/EEA  
    Global end of trial date
    09 Nov 2005

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

    Trial information

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    Trial identification
    Sponsor protocol code
    D9614C00097
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astrazeneca LP
    Sponsor organisation address
    1800 Concord Pike, Wilmington, DE, United States, 19850-5437
    Public contact
    Clinical Trial Transparency, Astrazeneca LP, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Marta Illueca, MD FAAP, Astrazeneca LP, 01 302 885 1487,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000331-PIP01-08
    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
    09 Nov 2005
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.
    Protection of trial subjects
    Before first patient into the study, a representative of AstraZeneca visited the investigational study site to: • determine the adequacy of the facilities • discuss with the investigator(s) (and other personnel involved with the study) their responsibilities with regard to protocol adherence, and the responsibilities of AstraZeneca or its representatives. This was documented in a Clinical Study Agreement between AstraZeneca and the investigator. During the study, a monitor from AstraZeneca or company representing AstraZeneca had regular contacts with the investigational site, including visits to: • provide information and support to the investigator(s) • confirm that facilities remained acceptable • confirm that the investigational team was adhering to the protocol, that data were being accurately recorded in the CRFs, and that investigational product accountability checks were being performed • perform source data verification (a comparison of the data in the CRFs with the patient’s medical records at the hospital or practice, and other records relevant to the study). This required direct access to all original records for each patient (eg, clinic charts).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2004
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    United States: 83
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    France: 7
    Worldwide total number of subjects
    109
    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)
    20
    Children (2-11 years)
    89
    Adolescents (12-17 years)
    0
    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
    		 First patient enrolled: 13 October 2004 Last patient completed: 09 November 2005

    Pre-assignment
    Screening details
    		 Patients underwent screening procedures within 21 days prior to Day 0. . Information on those patients who failed screening was recorded on a Screening Log. 109 patientents were elgible for enrollemtn/randomisation.

    Period 1
    Period 1 title
    Randomized Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Esomeprazole 5 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg Oral

    Arm title
    		 Esomeprazole 10 mg Wt<20 kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral

    Arm title
    		 Esomeprazole 10 mg Wt >= 20 kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral

    Arm title
    		 Esomeprazole 20 mg Wt >= 20kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 oral

    Number of subjects in period 1
    		Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Started
    26
    23
    31
    29
    Completed
    24
    22
    26
    29
    Not completed
    2
    1
    5
    0
         Consent withdrawn by subject
    -
    -
    1
    -
         Incorrect Rand & Started Exclusion. Med.
    2
    -
    1
    -
         Adverse event, non-fatal
    -
    1
    2
    -
         Lack of efficacy
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Esomeprazole 5 mg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 10 mg Wt<20 kg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 10 mg Wt >= 20 kg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 20 mg Wt >= 20kg
    Reporting group description
    		 -

    Reporting group values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg Total
    Number of subjects
    		 26 23 31 29 109
    Age categorical
    Number of subjects in each age category
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 12 8 0 0 20
        Children (2-11 years)
    		 14 15 31 29 89
    Age continuous
    Units: years
        median (full range (min-max))
    		 2 (1 to 6) 2 (1 to 6) 9 (4 to 11) 8 (4 to 11) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14 14 11 53
        Male
    		 12 9 17 18 56
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat

    Subject analysis sets values
    		 ITT
    Number of subjects
    109
    Age categorical
    Number of subjects in each age category
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    20
        Children (2-11 years)
    89
    Age continuous
    Units: years
        median (full range (min-max))
    6 (1 to 11)
    Gender categorical
    Units: Subjects
        Female
    53
        Male
    56

    End points

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    End points reporting groups
    Reporting group title
    Esomeprazole 5 mg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 10 mg Wt<20 kg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 10 mg Wt >= 20 kg
    Reporting group description
    		 -

    Reporting group title
    Esomeprazole 20 mg Wt >= 20kg
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat

    Primary: Number and percentage of subjects whose Physician Global Assesment score improved from baseline at their fianl visit

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    End point title
    		 Number and percentage of subjects whose Physician Global Assesment score improved from baseline at their fianl visit [1]
    End point description
    End point type
    Primary
    End point timeframe
    End of 8 week treatment period (final visit)
    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 analyses were specified. Only discriptive statistics are provided
    End point values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Number of subjects analysed
    26
    23
    31
    29
    Units: Number (perecentage) of patients
    18
    15
    25
    23
    No statistical analyses for this end point

    Secondary: Change from baseline at final visit in mean Heartburn Score

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    End point title
    		 Change from baseline at final visit in mean Heartburn Score
    End point description
    Change from baseline at final visit in mean Heartburn Score
    End point type
    Secondary
    End point timeframe
    From baseline to final visit
    End point values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Number of subjects analysed
    14 [2]
    10 [3]
    19 [4]
    13 [5]
    Units: Change in average score
        arithmetic mean (standard deviation)
    -1.15 ( 0.93 )
    -1.09 ( 0.86 )
    -1.32 ( 0.67 )
    -1.22 ( 0.85 )
    Notes
    [2] - Only patients with Heartburn at baseline were analysed
    [3] - Only patients with Heartburn at baseline were analysed
    [4] - Only patients with Heartburn at baseline were analysed
    [5] - Only patients with Heartburn at baseline were analysed
    No statistical analyses for this end point

    Secondary: Change from baseline at final visit in mean Acid Regurtation Score

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    End point title
    		 Change from baseline at final visit in mean Acid Regurtation Score
    End point description
    Change from baseline at final visit in mean Acid Regurtation Score
    End point type
    Secondary
    End point timeframe
    Baseline to final visit
    End point values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Number of subjects analysed
    17 [6]
    11 [7]
    20 [8]
    11 [9]
    Units: Change in mean score
        arithmetic mean (standard deviation)
    -1.18 ( 0.81 )
    -1.32 ( 0.93 )
    -1.24 ( 0.56 )
    -1.38 ( 0.81 )
    Notes
    [6] - Only patients with Acid Regurgitation at baseline were analysed
    [7] - Only patients with Acid Regurgitation at baseline were analysed
    [8] - Only patients with Acid Regurgitation at baseline were analysed
    [9] - Only patients with Acid Regurgitation at baseline were analysed
    No statistical analyses for this end point

    Secondary: Change from baseline at final visit in mean Epigastric Pain Score

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    End point title
    		 Change from baseline at final visit in mean Epigastric Pain Score
    End point description
    Change from baseline at final visit in mean Epigastric Pain Score
    End point type
    Secondary
    End point timeframe
    From baseline to final visit
    End point values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Number of subjects analysed
    16 [10]
    13 [11]
    15 [12]
    15 [13]
    Units: Change in mean score
        arithmetic mean (standard deviation)
    -1.42 ( 0.61 )
    -1.02 ( 0.69 )
    -1.3 ( 0.65 )
    -1.37 ( 0.67 )
    Notes
    [10] - Only patients with Epigastric Pain at baseline were analysed
    [11] - Only patients with Epigastric Pain at baseline were analysed
    [12] - Only patients with Epigastric Pain at baseline were analysed
    [13] - Only patients with Epigastric Pain at baseline were analysed
    No statistical analyses for this end point

    Secondary: Number of patients with erosive esophagitis resolution

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    End point title
    		 Number of patients with erosive esophagitis resolution
    End point description
    Number of patients whose EE was resolved at end of study. only patients who had EE at baseline and had an end of studyt endoscope are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Final visit
    End point values
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt<20 kg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg
    Number of subjects analysed
    11 [14]
    11 [15]
    10 [16]
    13 [17]
    Units: Patients
    11
    9
    9
    11
    Notes
    [14] - Only patients with baseline EE & end of study endoscope were analyzed
    [15] - Only patients with baseline EE & end of study endoscope were analyzed
    [16] - Only patients with baseline EE & end of study endoscope were analyzed
    [17] - Only patients with baseline EE & end of study endoscope were analyzed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were reported from time of enrollment Non-serious adverse events were reported after taking randomized treatment until end of eight week treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Esomeprazole 5 mg
    Reporting group description
    		 Esomeprazole 5 mg

    Reporting group title
    Esomeprazole 10 mg Wt >= 20 kg
    Reporting group description
    		 Esomeprazole 10 mg Wt >= 20 kg

    Reporting group title
    Esomeprazole 20 mg Wt >= 20kg
    Reporting group description
    		 Esomeprazole 20 mg Wt >= 20kg

    Reporting group title
    Esomeprazole 10 mg Wt<20 kg
    Reporting group description
    		 Esomeprazole 10 mg Wt<20 kg

    Serious adverse events
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg Esomeprazole 10 mg Wt<20 kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Vomiting aggravated
    Additional description: Intractable/bilious vomiting
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Airway obstruction on anesthetic induction
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Esomeprazole 5 mg Esomeprazole 10 mg Wt >= 20 kg Esomeprazole 20 mg Wt >= 20kg Esomeprazole 10 mg Wt<20 kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 25 (68.00%)
    26 / 31 (83.87%)
    24 / 29 (82.76%)
    15 / 23 (65.22%)
    Nervous system disorders
    headache
         subjects affected / exposed
    1 / 25 (4.00%)
    7 / 31 (22.58%)
    4 / 29 (13.79%)
    0 / 23 (0.00%)
         occurrences all number
    1
    8
    4
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 31 (16.13%)
    3 / 29 (10.34%)
    4 / 23 (17.39%)
         occurrences all number
    5
    7
    3
    4
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 31 (6.45%)
    2 / 29 (6.90%)
    2 / 23 (8.70%)
         occurrences all number
    5
    2
    2
    2
    Gastrointestinal disorders
    Vomiting alone
         subjects affected / exposed
    5 / 25 (20.00%)
    6 / 31 (19.35%)
    7 / 29 (24.14%)
    2 / 23 (8.70%)
         occurrences all number
    6
    8
    16
    4
    Diarrhoea NOS
         subjects affected / exposed
    4 / 25 (16.00%)
    6 / 31 (19.35%)
    3 / 29 (10.34%)
    0 / 23 (0.00%)
         occurrences all number
    4
    6
    3
    0
    Constipation
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
    3 / 23 (13.04%)
         occurrences all number
    1
    2
    1
    3
    Respiratory, thoracic and mediastinal disorders
    cough
         subjects affected / exposed
    4 / 25 (16.00%)
    5 / 31 (16.13%)
    3 / 29 (10.34%)
    1 / 23 (4.35%)
         occurrences all number
    4
    6
    3
    2
    Nasal congestion
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 31 (9.68%)
    2 / 29 (6.90%)
    3 / 23 (13.04%)
         occurrences all number
    2
    5
    2
    4
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 31 (12.90%)
    1 / 29 (3.45%)
    1 / 23 (4.35%)
         occurrences all number
    1
    4
    1
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
    3 / 23 (13.04%)
         occurrences all number
    2
    1
    2
    4
    Viral infection
         subjects affected / exposed
    0 / 25 (0.00%)
    4 / 31 (12.90%)
    2 / 29 (6.90%)
    0 / 23 (0.00%)
         occurrences all number
    0
    4
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
    0 / 23 (0.00%)
         occurrences all number
    3
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2004
    To update the procedures and entry requirements before the study was started.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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