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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 b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin

    Summary
    EudraCT number
    		 2015-000205-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    03 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A00426
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00619801
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Pharma
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years.
    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. A HIPAA agreement was inserted into the final informed consent form for sites in the United States.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    13 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: 173
    Worldwide total number of subjects
    173
    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)
    25
    Children (2-11 years)
    148
    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
    		 A00426 began recruitment within the United States of America in March 2008. The study concluded in July 2008. A total of 173 were randomized into the study.

    Pre-assignment
    Screening details
    		 N/A

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

    Arm title
    		 Levocetirizine
    Arm description
    		 Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		Placebo Levocetirizine
    Started
    59
    114
    Safety Population
    59
    114
    Completed
    58
    111
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    1
         Loss of efficacy
    -
    1
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    Reporting group title
    Levocetirizine
    Reporting group description
    		 Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    Reporting group values
    		 Placebo Levocetirizine Total
    Number of subjects
    		 59 114 173
    Age Categorical
    Units: Subjects
        <=18 years
    		 59 114 173
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.75 ± 1.45 3.78 ± 1.38 -
    Gender Categorical
    Units: Subjects
        Female
    		 23 49 72
        Male
    		 36 65 101
    Region of Enrollment
    Units: Subjects
        United States
    		 59 114 173

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    Reporting group title
    Levocetirizine
    Reporting group description
    		 Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56
    110
    Units: beats per minute
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -1.5 ± 14.1
    1.3 ± 14.2
    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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56 [3]
    110 [4]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.2 ± 85.9
    -6.9 ± 83.4
    Notes
    [3] - Safety Population; only non-missing values were analyzed.
    [4] - Safety Population; only non-missing values were analyzed.
    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 [5]
    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
    [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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56 [6]
    110 [7]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.5 ± 9.6
    -0.8 ± 11
    Notes
    [6] - Safety Population; only non-missing values were analyzed.
    [7] - Safety Population; only non-missing values were analyzed.
    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 [8]
    End point description
    The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
    End point type
    Primary
    End point timeframe
    Baseline, 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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56 [9]
    110 [10]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.3 ± 6.6
    0.9 ± 7.1
    Notes
    [9] - Safety Population; only non-missing values were analyzed.
    [10] - Safety Population; only non-missing values were analyzed.
    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 [11]
    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
    [11] - 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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56 [12]
    110 [13]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -2.8 ± 17.2
    -1.5 ± 19.2
    Notes
    [12] - Safety Population; only non-missing values were analyzed.
    [13] - Safety Population; only non-missing values were analyzed.
    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) [14]
    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
    [14] - 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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    56 [15]
    110 [16]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -5.5 ± 14.3
    -0.3 ± 16.6
    Notes
    [15] - Safety Population; only non-missing values were analyzed.
    [16] - Safety Population; only non-missing values were analyzed.
    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) [17]
    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
    [17] - 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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    57 [18]
    112 [19]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    372.6 ± 16.5
    368.9 ± 19.4
    Notes
    [18] - Safety Population; only non-missing values were analyzed.
    [19] - Safety Population; only non-missing values were analyzed.
    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) [20]
    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
    [20] - 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 A00426 was “to evaluate the safety of levocetirizine dihydrochloride in pediatric subjects aged from 1 to less than 6 years”. 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
    57 [21]
    111 [22]
    Units: milliseconds
    arithmetic mean (standard deviation)
        mean (standard deviation)
    369.8 ± 17.1
    370.5 ± 18.5
    Notes
    [21] - Safety Population; only non-missing values were analyzed.
    [22] - Safety Population; only non-missing values were analyzed.
    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
    54
    104
    Units: micromole per liter [µmol/L]
    median (full range (min-max))
        median (full range)
    0 (-10.26 to 3.42)
    0 (-8.55 to 5.13)
    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
    54
    105
    Units: unit per liter [U/L]
    median (full range (min-max))
        median (full range)
    -1.5 (-12 to 167)
    1 (-21 to 138)
    No statistical analyses for this end point

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

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    End point title
    		 Change from baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in aspartate aminotransferase (AST)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 14 days
    End point values
    		 Placebo Levocetirizine
    Number of subjects analysed
    53
    105
    Units: unit per liter [U/L]
    median (full range (min-max))
        median (full range)
    1 (-15 to 52)
    1 (-16 to 58)
    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
    54
    105
    Units: millimole per liter [mmol/L]
    median (full range (min-max))
        median (full range)
    -0.1785 (-2.142 to 2.142)
    0 (-3.57 to 3.213)
    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
    54
    105
    Units: micromole per liter [µmol/L]
    median (full range (min-max))
        median (full range)
    -0.884 (-17.68 to 13.26)
    1.768 (-15.912 to 16.796)
    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 treatment 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
    		 Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).

    Serious adverse events
    		 Levocetirizine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Pyrexia
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (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
    39 / 114 (34.21%)
    21 / 59 (35.59%)
    General disorders and administration site conditions
    Pyrexia
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    5 / 114 (4.39%)
    1 / 59 (1.69%)
         occurrences all number
    5
    1
    Fatigue
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Pain
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Hunger
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Thirst
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    4 / 114 (3.51%)
    5 / 59 (8.47%)
         occurrences all number
    4
    6
    Asthma
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Wheezing
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Epistaxis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    Nasal discomfort
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract congestion
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Nervousness
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Middle insomnia
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Restlessness
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Skin laceration
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Head injury
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Somnolence
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Headache
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Psychomotor hyperactivity
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    0
    3
    Ear and labyrinth disorders
    Cerumen impaction
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Eye disorders
    Eye swelling
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 59 (3.39%)
         occurrences all number
    4
    2
    Vomiting
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 59 (3.39%)
         occurrences all number
    4
    2
    Teething
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Eructation
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Constipation
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Salivary hypersecretion
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Aphthous stomatitis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Scab
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Dermatitis diaper
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Swelling face
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Rash
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Urticaria
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Rash papular
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 59 (3.39%)
         occurrences all number
    3
    2
    Nasopharyngitis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Otitis media
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 59 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis viral
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Viral rash
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Viral pharyngitis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Gastroenteritis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Folliculitis
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Anorexia
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Dehydration
    alternative dictionary used: MedDRA 9.0
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1

    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
    The protocol was amended to incorporate changes based on comments received by the Food and Drug Administration to the pre-IND file dated 14 November 2007. Efficacy assessments and serum drug concentration to assess compliance/ drug exposure were incorporated. Children aged 1 but less than 2 years were added to the inclusion criteria. The upper age for inclusion was clarified for children to less than 6 years of age. Information regarding pharmacokinetic modeling to predict dosing regimen in children less than 6 was added.
    28 Mar 2008
    The protocol was amended primarily to revise the exclusion criteria to require the specified washout period for subjects who are receiving exclusionary medications via breast milk during the course of the study. The laboratory texts exclusion criteria was amended to clarify that prior written approval from the UCB Clinical Research Physician for out of range laboratory tests in not required before enrolling a subject in the study. The decision to enroll such a subject was left up to the discretion of the Investigator. The prohibited concomitant medications exclusion criterion was amended to clarify that subjects taking single ingredient guaifenesin products at the time of study entry will not be required to perform the wash-out period, and that is the only cough or cold medication that subjects were allowed to take during the study period.

    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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