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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria

    Summary
    EudraCT number
    		 2007-003458-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Sep 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    18 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A00423
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00628108
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB, Inc.
    Sponsor organisation address
    1950 Lake Park Drive, Smyrna, United States, 30080
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the safety of levocetirizine dihydrochloride (LCTZ) in pediatric subjects aged from 6 to 11 months.
    Protection of trial subjects
    Adequate information was provided to the subject’s caregiver in both oral and written form and consent was obtained in writing prior to performance of any study specific procedure. The content and process of obtaining informed consent was in accordance with all applicable regulatory and IEC/IRB requirements.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    20 Mar 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
    United States: 69
    Worldwide total number of subjects
    69
    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)
    69
    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
    		 The A00423 study began enrollment in March 2008. The study concluded in September 2008 with 69 subjects enrolled.

    Pre-assignment
    Screening details
    		 One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral liquid once a day for two weeks.

    Arm title
    		 Levocetirizine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levocetirizine dihydrochloride
    Investigational medicinal product code
    LCTZ
    Other name
    Xyzal
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks.

    Number of subjects in period 1
    		Placebo Levocetirizine
    Started
    23
    46
    Completed
    22
    43
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    2
         SAE, non-fatal + AE, non-serious non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Levocetirizine
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Levocetirizine Total
    Number of subjects
    		 23 46 69
    Age categorical
    Units: Subjects
        <=18 years
    		 23 46 69
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 8.93 ± 1.77 8.92 ± 1.64 -
    Gender categorical
    Units: Subjects
        Male
    		 10 29 39
        Female
    		 13 17 30
    Race
    Units: Subjects
        Caucasian
    		 12 23 35
        Black
    		 9 14 23
        Mixed race
    		 2 9 11
    Weight
    Units: lb
        arithmetic mean (standard deviation)
    		 18.51 ± 2.73 19.55 ± 2.97 -
    Height
    Units: inch
        arithmetic mean (standard deviation)
    		 27.33 ± 1.67 27.97 ± 1.45 -
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 17.46 ± 2.15 17.53 ± 1.75 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Levocetirizine
    Reporting group description
    		 -

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in ventricular rate (VR)

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in ventricular rate (VR) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: beats per minute
    arithmetic mean (standard deviation)
        mean (SD)
    -7.6 ± 17.3
    -4 ± 16.9
    No statistical analyses for this end point

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR interval

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR interval [2]
    End point description
    The RR interval refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    Notes
    [2] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    28 ± 63.9
    14.9 ± 58.4
    No statistical analyses for this end point

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR interval

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR interval [3]
    End point description
    The PR interval refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    Notes
    [3] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    0.8 ± 11.3
    3.1 ± 11.3
    No statistical analyses for this end point

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS duration

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS duration [4]
    End point description
    The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    Notes
    [4] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    1.4 ± 6.4
    0.3 ± 5.7
    No statistical analyses for this end point

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT interval

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT interval [5]
    End point description
    The QT interval refers to the respective time in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    Notes
    [5] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    4.5 ± 21.1
    -0.3 ± 18.7
    No statistical analyses for this end point

    Primary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT interval corrected for heart rate using Fridericia’s formula (QTcF)

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT interval corrected for heart rate using Fridericia’s formula (QTcF) [6]
    End point description
    The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    Baseline, 14 days
    Notes
    [6] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    20
    38
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    -1.3 ± 20.9
    -3.9 ± 17.3
    No statistical analyses for this end point

    Primary: Absolute value of QT interval corrected for heart rate using Fridericia’s formula (QTcF) at Visit 3 (Day 7)

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    End point title
    		 Absolute value of QT interval corrected for heart rate using Fridericia’s formula (QTcF) at Visit 3 (Day 7) [7]
    End point description
    The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    7 days
    Notes
    [7] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    21
    42
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    360.3 ± 15.2
    354.5 ± 21.1
    No statistical analyses for this end point

    Primary: Absolute value of QT interval corrected for heart rate using Fridericia’s formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)

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    End point title
    		 Absolute value of QT interval corrected for heart rate using Fridericia’s formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) [8]
    End point description
    The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
    End point type
    Primary
    End point timeframe
    14 days
    Notes
    [8] - 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: The primary objective of study A00424 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 6 to less than 11 months”. So the purpose of the study was the description of the safety profile of levocetirizine dihydrochloride across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    23
    39
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (SD)
    355.3 ± 17.7
    351.9 ± 18
    No statistical analyses for this end point

    Secondary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in total bilirubin

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in total bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    19
    35
    Units: micromole per liter [µmol/L]
    median (full range (min-max))
        median (full range)
    0 (-1.71 to 1.71)
    0 (-3.42 to 3.42)
    No statistical analyses for this end point

    Secondary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in alanine aminotransferase (ALT)

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in alanine aminotransferase (ALT)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    19
    34
    Units: unit per liter [U/L]
    median (full range (min-max))
        median (full range)
    -2 (-27 to 15)
    -1 (-24 to 41)
    No statistical analyses for this end point

    Secondary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in aspartate aminontransferase (AST)

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in aspartate aminontransferase (AST)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    19
    34
    Units: unit per liter [U/L]
    median (full range (min-max))
        median (full range)
    2 (-15 to 21)
    -1 (-36 to 23)
    No statistical analyses for this end point

    Secondary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in blood urea nitrogen

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in blood urea nitrogen
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    19
    36
    Units: millimole per liter [mmol/L]
    median (full range (min-max))
        median (full range)
    0 (-0.714 to 2.856)
    0 (-3.927 to 4.641)
    No statistical analyses for this end point

    Secondary: Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in blood creatinine

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in blood creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    19
    36
    Units: micromole per liter [μmol/L]
    median (full range (min-max))
        median (full range)
    -0.884 (-9.724 to 20.332)
    -0.884 (-18.564 to 10.608)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Population including all subjects who were dispensed study medication at least once.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Levocetirizine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Levocetirizine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Otitis media acute
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (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: 0%
    Non-serious adverse events
    		 Levocetirizine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 45 (64.44%)
    17 / 24 (70.83%)
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Pyrexia
         subjects affected / exposed
    7 / 45 (15.56%)
    4 / 24 (16.67%)
         occurrences all number
    7
    4
    Injection site pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Eye disorders
    Eye discharge
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 45 (13.33%)
    1 / 24 (4.17%)
         occurrences all number
    6
    1
    Vomiting
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 24 (4.17%)
         occurrences all number
    3
    1
    Teething
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 24 (4.17%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    Productive cough
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Wheezing
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Asthma
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Hyperkeratosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Heat rash
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Rash
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    2 / 45 (4.44%)
    2 / 24 (8.33%)
         occurrences all number
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Bronchitis acute
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (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? Yes
    Date
    Amendment
    20 Feb 2008
    A summary of the changes are as follows: - Efficacy and serum drug concentration were included to assess compliance/drug exposure. - Risk factor information for SIDS and references were updated. - Information was included on the Population PK modeling that was used to predict the appropriate dosing regimens for children less than 6 years of age.
    28 Mar 2008
    The primary purpose of this amendment was to revise the exclusion criteria to require the specified wash-out periods for subjects who were receiving exclusionary medication via breast milk during the course of the study.

    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.
    N/A
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