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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age

    Summary
    EudraCT number
    		 2006-002001-31
    Trial protocol
    		 DE   GB   Outside EU/EEA  
    Global end of trial date
    14 Apr 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    D9614C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    1800 Concord Pike, Wilmington, United States, 19850-5437
    Public contact
    ClinicalTrialTransparency, Astrazeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Marta Illueca, MD, FAAP, AstraZeneca, 1 3028851487, aztrial_results_posting@astrazeneca.com
    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
    14 Apr 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Apr 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms of GERD as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
    Protection of trial subjects
    There was no data monitoring board; however a Data and Safety Monitoring Plan was available for this study. The Clinical Study Physician monitored the SAEs on a continuous basis. A Drug Safety Physician reviewed all serious unexpected reports that were assessed by the investigator to be causally related to study drug within 15 days from AstraZeneca notification of the event. In addition, a safety subteam, consisting of the AstraZeneca Drug Safety Physician(s), Drug Safety Scientist, Clinical Study Physician, Study Delivery, and other Clinical Study Team members met on a regular basis to review blinded study data regarding SAEs, non-serious AEs, discontinuation criteria, clinically significant laboratory data, and vital signs. The safety subteam could request additional evaluations at their discretion from the study center.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2006
    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 Kingdom: 12
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Australia: 31
    Worldwide total number of subjects
    61
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    23
    Infants and toddlers (28 days-23 months)
    38
    Children (2-11 years)
    0
    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
    		 Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 61
    Number of subjects completed
    		 52

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 6
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Reason: Number of subjects
    		 Study drug was defrosted: 1
    Period 1
    Period 1 title
    Treatment phase
    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
    Arm description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg/kg/day administered by oral gavage or nippling

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg/kg/day by oral gavage or by nippling

    Number of subjects in period 1 [1]
    		Esomeprazole Placebo
    Started
    26
    26
    Completed
    25
    26
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 61 patients were screened, 52 randomized (=>6 were incorrect enrolled, 2 voluntary discontinuation by parent/guardian, 1 other reason). The baseline numbers reflect the randomized patients.
    Period 2
    Period 2 title
    Study completion to safety follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Esomeprazole
    Arm description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Esomeprazole Placebo
    Started
    25
    26
    Completed
    25
    25
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Esomeprazole
    Reporting group description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Reporting group values
    		 Esomeprazole Placebo Total
    Number of subjects
    		 26 26 52
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 7 9 16
        Infants and toddlers (28 days-23 months)
    		 19 17 36
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Days
        arithmetic mean (standard deviation)
    		 46.5 ( 30.3 ) 46.5 ( 31.2 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 15 15 30
        Male
    		 11 11 22

    End points

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    End points reporting groups
    Reporting group title
    Esomeprazole
    Reporting group description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
    Reporting group title
    Esomeprazole
    Reporting group description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Primary: Change from baseline in normalized number of GERD events observed from video and cardiorespiratory monitoring

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    End point title
    		 Change from baseline in normalized number of GERD events observed from video and cardiorespiratory monitoring
    End point description
    The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
    End point type
    Primary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    25
    26
    Units: Mean Number of Events
        arithmetic mean (standard deviation)
    -28.01 ( 77.7 )
    -24.79 ( 44.25 )
    Statistical analysis title
    		 ANCOVA of change from baseline
    Statistical analysis description
    change from baseline in log-transformed events, adjusting for treatment and baseline
    Comparison groups
    Esomeprazole v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9217
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.18
         upper limit
    		 14.87

    Secondary: Change from baseline in normalized number of GERD events during video and cardiorespiratory monitoring associated with acid reflux

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    End point title
    		 Change from baseline in normalized number of GERD events during video and cardiorespiratory monitoring associated with acid reflux
    End point description
    Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    25
    25
    Units: Mean Number of Events
        arithmetic mean (standard deviation)
    -21.79 ( 40.37 )
    -13.49 ( 32.76 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of reflux episodes (acid or non-acid)

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    End point title
    		 Change from baseline in number of reflux episodes (acid or non-acid)
    End point description
    Number of reflux episodes based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    -14.55 ( 49.58 )
    6.27 ( 28.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of acidic reflux episodes

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    End point title
    		 Change from baseline in number of acidic reflux episodes
    End point description
    Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    -37.75 ( 32.38 )
    2.36 ( 18.35 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of weakly acidic reflux episodes

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    End point title
    		 Change from baseline in number of weakly acidic reflux episodes
    End point description
    Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    22.6 ( 45.17 )
    3.59 ( 21.6 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of non acidic reflux episodes

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    End point title
    		 Change from baseline in number of non acidic reflux episodes
    End point description
    Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    0.6 ( 1.14 )
    0.32 ( 0.99 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of liquid acidic reflux episodes

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    End point title
    		 Change from baseline in number of liquid acidic reflux episodes
    End point description
    Number of reflux episodes based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    -19 ( 52.03 )
    3.05 ( 31.19 )
    No statistical analyses for this end point

    Secondary: Change from baseline in number of mixed gas/liquid acidic reflux episodes

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    End point title
    		 Change from baseline in number of mixed gas/liquid acidic reflux episodes
    End point description
    Number of reflux episodes based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Mean Number of Episodes
        arithmetic mean (standard deviation)
    4.45 ( 17.44 )
    3.27 ( 13.84 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean bolus clearance time

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    End point title
    		 Change from baseline in mean bolus clearance time
    End point description
    Based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Seconds
        arithmetic mean (standard deviation)
    -0.29 ( 24.56 )
    -4.05 ( 25.61 )
    No statistical analyses for this end point

    Secondary: Change from baseline in mean acid clearance time

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    End point title
    		 Change from baseline in mean acid clearance time
    End point description
    Based on 24-hour impedance monitoring data
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Seconds
        arithmetic mean (standard deviation)
    5.93 ( 64.32 )
    -6.36 ( 45.38 )
    No statistical analyses for this end point

    Secondary: Change from baseline in percentage time with pH<4.0

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    End point title
    		 Change from baseline in percentage time with pH<4.0
    End point description
    Percentage time with pH<4 during 24-hour pH monitoring
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Percentage
        arithmetic mean (standard deviation)
    -10.73 ( 12.63 )
    2.24 ( 12.38 )
    No statistical analyses for this end point

    Secondary: Change from baseline in percentage time with pH within 4.0-6.9

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    End point title
    		 Change from baseline in percentage time with pH within 4.0-6.9
    End point description
    Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (10-14 days)
    End point values
    		 Esomeprazole Placebo
    Number of subjects analysed
    20
    22
    Units: Percentage
        arithmetic mean (standard deviation)
    9.84 ( 12.64 )
    -2.6 ( 12.18 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During enrollment and randomized treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Reporting group title
    Esomeprazole
    Reporting group description
    		 Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.

    Serious adverse events
    		 Placebo Esomeprazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Inappropriate Device Signal Detection
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia Neonatal
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyanosis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Infantile Apnoeic Attack
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Esomeprazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 26 (26.92%)
    6 / 26 (23.08%)
    Investigations
    Oxygen Saturation Decreased
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    5
    2
    Cardiac disorders
    Cyanosis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia Neonatal
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Oedema Peripheral
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Deafness Neurosensory
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Retinopathy Of Prematurity
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Flatulence
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Gastrooesophageal Reflux Disease
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Diarrhoea
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Neonatal Infection
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Bronchiolitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Urinary Tract Infection Neonatal
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0

    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.
    Because of recruitment challenges, only 52 patients out of the planned 90 were enrolled.
    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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