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    Clinical Trial Results:
    A Phase III, Multi-Center, Randomized, Parallel-Group, Placebo-Controlled and Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects with Perennial Allergic Rhinitis.

    Summary
    EudraCT number
    		 2017-000186-76
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2017
    First version publication date
    09 Mar 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-4117-200
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01918033
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    26 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score (TNSS) among Japanese participants with perennial allergic rhinitis.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2013
    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
    Japan: 608
    Worldwide total number of subjects
    608
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    82
    Adults (18-64 years)
    521
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Male and female participants who were at least 12 years of age and had perennial allergic rhinitis were enrolled in this study.

    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, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    Participants were blinded to study treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desloratadine 5 mg
    Arm description
    		 Participants received one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    MK-4117
    Other name
    CLARINEX®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One desloratadine 5 mg tablet and one placebo tablet once daily for up to 2 weeks

    Arm title
    		 Desloratadine 10 mg
    Arm description
    		 Participants received two desloratadine 5 mg tablets orally once daily for up to 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    MK-4117
    Other name
    CLARINEX®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two desloratadine 5 mg tablets once daily for up to 2 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants received two placebo tablets orally once daily for up to 2 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placeobo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two placebo tablets once daily for up to 2 weeks

    Number of subjects in period 1
    		Desloratadine 5 mg Desloratadine 10 mg Placebo
    Started
    203
    203
    202
    Treated
    202
    203
    201
    Completed
    198
    201
    199
    Not completed
    5
    2
    3
         Consent withdrawn by subject
    2
    1
    -
         Adverse event, non-fatal
    1
    -
    2
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 Participants received one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    		 Participants received two desloratadine 5 mg tablets orally once daily for up to 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received two placebo tablets orally once daily for up to 2 weeks

    Reporting group values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo Total
    Number of subjects
    		 203 203 202 608
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 30 28 24 82
        Adults (18-64 years)
    		 170 175 176 521
        From 65-84 years
    		 3 0 2 5
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 34.3 ( 13.1 ) 33.7 ( 11.9 ) 34.7 ( 12.6 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 116 105 121 342
        Male
    		 87 98 81 266

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 Participants received one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    		 Participants received two desloratadine 5 mg tablets orally once daily for up to 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received two placebo tablets orally once daily for up to 2 weeks

    Primary: Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2

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    End point title
    		 Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2
    End point description
    The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
    End point type
    Primary
    End point timeframe
    Baseline and Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
        least squares mean (confidence interval 95%)
    -1.96 (-2.25 to -1.67)
    -1.94 (-2.23 to -1.65)
    -1.87 (-2.16 to -1.58)
    Statistical analysis title
    		 TNSS: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.661 [1]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares (LS) Means
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.31
    Notes
    [1] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 TNSS: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.707 [2]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.32
    Notes
    [2] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.

    Primary: Number of Participants Experiencing an Adverse Event (AE)

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    End point title
    		 Number of Participants Experiencing an Adverse Event (AE) [3]
    End point description
    An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized. The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Week 4
    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: No statistical analysis was planned for or performed for this end point.
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Participants
    27
    29
    20
    No statistical analyses for this end point

    Primary: Number of Participants Discontinuing Study Drug Due to an AE

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    End point title
    		 Number of Participants Discontinuing Study Drug Due to an AE [4]
    End point description
    An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. The ASaT population consisted of all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Week 2
    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: No statistical analysis was planned for or performed for this end point.
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Participants
    1
    0
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in TNSS Assessed by the Investigator at Day 3 and Week 1

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    End point title
    		 Change From Baseline in TNSS Assessed by the Investigator at Day 3 and Week 1
    End point description
    The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Change from Baseline (BL) at Day 3
    -1.12 (-1.38 to -0.86)
    -1.11 (-1.37 to -0.85)
    -0.63 (-0.89 to -0.37)
        Change from BL at Week 1
    -1.39 (-1.68 to -1.09)
    -1.39 (-1.69 to -1.1)
    -1.48 (-1.78 to -1.18)
    Statistical analysis title
    		 TNSS Day 3: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [5]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 -0.11
    Notes
    [5] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 TNSS Day 3: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013 [6]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.1
    Notes
    [6] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 TNSS Week 1: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.569 [7]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.53
    Notes
    [7] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 TNSS Week 1: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.685 [8]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.5
    Notes
    [8] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.

    Secondary: Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Sneezing: Change from BL at Day 3
    -0.21 (-0.3 to -0.13)
    -0.29 (-0.38 to -0.2)
    -0.13 (-0.21 to -0.04)
        Sneezing: Change from BL at Week 1
    -0.27 (-0.36 to -0.17)
    -0.36 (-0.45 to -0.27)
    -0.38 (-0.47 to -0.29)
        Sneezing: Change from BL at Week 2
    -0.44 (-0.52 to -0.35)
    -0.51 (-0.59 to -0.42)
    -0.4 (-0.49 to -0.32)
        Rhinorrhea: Change from BL at Day 3
    -0.37 (-0.47 to -0.28)
    -0.32 (-0.41 to -0.22)
    -0.24 (-0.33 to -0.15)
        Rhinorrhea: Change from BL at Week 1
    -0.39 (-0.49 to -0.29)
    -0.38 (-0.48 to -0.28)
    -0.44 (-0.54 to -0.34)
        Rhinorrhea: Change from BL at Week 2
    -0.57 (-0.67 to -0.47)
    -0.53 (-0.63 to -0.43)
    -0.56 (-0.66 to -0.46)
        Nasal Congestion: Change from BL at Day 3
    -0.22 (-0.3 to -0.13)
    -0.17 (-0.26 to -0.09)
    -0.13 (-0.22 to -0.04)
        Nasal Congestion: Change from BL at Week 1
    -0.28 (-0.38 to -0.18)
    -0.22 (-0.32 to -0.13)
    -0.32 (-0.42 to -0.23)
        Nasal Congestion: Change from BL at Week 2
    -0.33 (-0.43 to -0.23)
    -0.33 (-0.43 to -0.23)
    -0.37 (-0.47 to -0.27)
        Nasal Itching: Change from BL at Day 3
    -0.32 (-0.42 to -0.22)
    -0.33 (-0.43 to -0.23)
    -0.15 (-0.25 to -0.05)
        Nasal Itching: Change from BL at Week 1
    -0.44 (-0.55 to -0.33)
    -0.44 (-0.55 to -0.34)
    -0.35 (-0.45 to -0.24)
        Nasal Itching: Change from BL at Week 2
    -0.63 (-0.74 to -0.53)
    -0.58 (-0.68 to -0.48)
    -0.52 (-0.62 to -0.42)
    Statistical analysis title
    		 Sneezing Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.547 [9]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.08
    Notes
    [9] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Sneezing Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067 [10]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.01
    Notes
    [10] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Rhinorrhea Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.895 [11]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.13
    Notes
    [11] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Rhinorrhea Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.627 [12]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.17
    Notes
    [12] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Congestion Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.535 [13]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.18
    Notes
    [13] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Congestion Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.557 [14]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.18
    Notes
    [14] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Itching Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.119 [15]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.03
    Notes
    [15] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Itching Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.403 [16]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.08
    Notes
    [16] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.

    Secondary: Change From Baseline in Nasal Finding Score Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Nasal Finding Score Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Swelling of INCM: Change from BL at Day 3
    -0.23 (-0.32 to -0.14)
    -0.17 (-0.26 to -0.08)
    -0.13 (-0.22 to -0.05)
        Swelling of INCM: Change from BL at Week 1
    -0.35 (-0.44 to -0.25)
    -0.31 (-0.4 to -0.21)
    -0.34 (-0.43 to -0.24)
        Swelling of INCM: Change from BL at Week 2
    -0.38 (-0.48 to -0.28)
    -0.34 (-0.44 to -0.24)
    -0.32 (-0.41 to -0.22)
        Coloring of INCM: Change from BL at Day 3
    -0.27 (-0.37 to -0.16)
    -0.26 (-0.36 to -0.15)
    -0.26 (-0.36 to -0.15)
        Coloring of INCM: Change from BL at Week 1
    -0.35 (-0.47 to -0.24)
    -0.38 (-0.49 to -0.27)
    -0.4 (-0.51 to -0.28)
        Coloring of INCM: Change from BL at Week 2
    -0.48 (-0.6 to -0.36)
    -0.48 (-0.6 to -0.37)
    -0.45 (-0.57 to -0.33)
        NDP: Change from BL at Day 3
    -0.23 (-0.32 to -0.14)
    -0.24 (-0.32 to -0.15)
    -0.18 (-0.27 to -0.09)
        NDP: Change from BL at Week 1
    -0.33 (-0.42 to -0.24)
    -0.36 (-0.45 to -0.26)
    -0.41 (-0.5 to -0.31)
        NDP: Change from BL at Week 2
    -0.41 (-0.51 to -0.32)
    -0.38 (-0.48 to -0.29)
    -0.44 (-0.54 to -0.35)
    Statistical analysis title
    		 Swelling Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.376 [17]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.07
    Notes
    [17] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Swelling Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.714 [18]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.11
    Notes
    [18] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Coloring Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.725 [19]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.13
    Notes
    [19] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Coloring Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.708 [20]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.13
    Notes
    [20] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 NDP Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68 [21]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.16
    Notes
    [21] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 NDP Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.373 [22]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.19
    Notes
    [22] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.

    Secondary: Change From Baseline in Eye Symptom Score Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Eye Symptom Score Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Change from BL at Day 3
    -0.17 (-0.27 to -0.08)
    -0.24 (-0.34 to -0.15)
    -0.13 (-0.22 to -0.04)
        Change from BL at Week 1
    -0.28 (-0.38 to -0.18)
    -0.35 (-0.44 to -0.25)
    -0.26 (-0.36 to -0.16)
        Change from BL at Week 2
    -0.38 (-0.48 to -0.28)
    -0.44 (-0.54 to -0.34)
    -0.37 (-0.46 to -0.27)
    Statistical analysis title
    		 Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.849 [23]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.12
    Notes
    [23] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.
    Statistical analysis title
    		 Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26 [24]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.06
    Notes
    [24] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as categorical variable.

    Secondary: Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    		 Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2=moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.
    End point type
    Secondary
    End point timeframe
    Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    200
    203
    201
    Units: Participants
        Day 3 (n=199, 201, 200)
    67
    61
    53
        Week 1 (n=200, 203, 201)
    72
    83
    91
        Week 2 (n=200, 203, 201)
    96
    93
    106
    Statistical analysis title
    		 Week 2: Desloratadine 5 mg v. Placebo
    Statistical analysis description
    Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34 [25]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.826
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.558
         upper limit
    		 1.223
    Notes
    [25] - Logistic model with global improvement rate as response variable and treatment, age strata and severity as factors
    Statistical analysis title
    		 Week 2: Desloratadine 10 mg v. Placebo
    Statistical analysis description
    Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.159 [26]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.755
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.116
    Notes
    [26] - Logistic model with global improvement rate as response variable and treatment, age strata and severity as factors

    Secondary: Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Change from BL at Day 3
    -0.18 (-0.26 to -0.1)
    -0.19 (-0.27 to -0.12)
    -0.07 (-0.15 to 0)
        Change from BL at Week 1
    -0.22 (-0.3 to -0.13)
    -0.21 (-0.29 to -0.12)
    -0.2 (-0.28 to -0.11)
        Change from BL at Week 2
    -0.25 (-0.34 to -0.16)
    -0.29 (-0.38 to -0.2)
    -0.27 (-0.36 to -0.19)
    Statistical analysis title
    		 Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.705 [27]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.14
    Notes
    [27] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.782 [28]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.1
    Notes
    [28] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable

    Secondary: Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries at Day 3, Week 1 and Week 2
    End point description
    Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Sneezing: Change from BL at Day 3
    -0.27 (-0.36 to -0.18)
    -0.32 (-0.41 to -0.23)
    -0.23 (-0.32 to -0.13)
        Sneezing: Change from BL at Week 1
    -0.38 (-0.48 to -0.29)
    -0.4 (-0.49 to -0.3)
    -0.3 (-0.39 to -0.2)
        Sneezing: Change from BL at Week 2
    -0.43 (-0.54 to -0.32)
    -0.45 (-0.55 to -0.35)
    -0.33 (-0.44 to -0.23)
        Rhinorrhea: Change from BL at Day 3
    -0.2 (-0.3 to -0.11)
    -0.29 (-0.39 to -0.19)
    -0.17 (-0.27 to -0.08)
        Rhinorrhea: Change from BL at Week 1
    -0.29 (-0.39 to -0.18)
    -0.36 (-0.46 to -0.26)
    -0.34 (-0.44 to -0.23)
        Rhinorrhea: Change from BL at Week 2
    -0.33 (-0.45 to -0.22)
    -0.38 (-0.5 to -0.27)
    -0.45 (-0.57 to -0.34)
        Nasal Congestion: Change from BL at Day 3
    -0.18 (-0.28 to -0.09)
    -0.17 (-0.27 to -0.08)
    -0.18 (-0.28 to -0.09)
        Nasal Congestion: Change from BL at Week 1
    -0.23 (-0.33 to -0.13)
    -0.24 (-0.34 to -0.14)
    -0.25 (-0.35 to -0.15)
        Nasal Congestion: Change from BL at Week 2
    -0.23 (-34 to -0.12)
    -0.26 (-0.37 to -0.15)
    -0.32 (-0.43 to -0.2)
        Nasal Itching: Change from BL at Day 3
    -0.29 (-0.39 to -0.19)
    -0.35 (-0.45 to -0.25)
    -0.22 (-0.33 to -0.12)
        Nasal Itching: Change from BL at Week 1
    -0.4 (-0.51 to -0.3)
    -0.42 (-0.53 to -0.32)
    -0.39 (-0.5 to -0.29)
        Nasal Itching: Change from BL at Week 2
    -0.52 (-0.64 to -0.4)
    -0.47 (-0.59 to -0.36)
    -0.44 (-0.56 to -0.33)
    Statistical analysis title
    		 Sneezing Week 2: Deloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175 [29]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.04
    Notes
    [29] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Sneezing Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.098 [30]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.02
    Notes
    [30] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Rhinorrhea Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.13 [31]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.27
    Notes
    [31] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Rhinorrhea Week 2: Desloratadine 10 mg. v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.375 [32]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.22
    Notes
    [32] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Congestion Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.285 [33]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.24
    Notes
    [33] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Congestion Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49 [34]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.21
    Notes
    [34] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Itching Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.345 [35]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.08
    Notes
    [35] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Itching Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.699 [36]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.13
    Notes
    [36] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable

    Secondary: Change From Baseline in Eye Symptom Score Reported in Participant Diaries at Day 3, Week 1 and Week 2

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    End point title
    		 Change From Baseline in Eye Symptom Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
    End point description
    Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 3, Week 1, Week 2
    End point values
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    202
    203
    201
    Units: Score on a Scale
    least squares mean (confidence interval 95%)
        Change from BL at Day 3
    -0.28 (-0.38 to -0.19)
    -0.25 (-0.34 to -0.15)
    -0.2 (-0.3 to -0.11)
        Change from BL at Week 1
    -0.31 (-0.4 to -0.21)
    -0.33 (-0.43 to -0.24)
    -0.26 (-0.35 to -0.16)
        Change from BL at Week 2
    -0.33 (-0.44 to -0.22)
    -0.35 (-0.45 to -0.24)
    -0.27 (-0.38 to -0.17)
    Statistical analysis title
    		 Week 2: Desloratadine 5 mg v. Placebo
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    403
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.414 [37]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.08
    Notes
    [37] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
    Statistical analysis title
    		 Week 2: Desloratadine 10 mg v. Placebo
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281 [38]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.06
    Notes
    [38] - Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 2 weeks after last dose of study drug (up to 4 weeks)
    Adverse event reporting additional description
    The population consisted of all participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    		 Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive two placebo tablets orally once daily for up to 2 weeks

    Serious adverse events
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 203 (0.00%)
    0 / 201 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 203 (0.00%)
    0 / 201 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Desloratadine 5 mg Desloratadine 10 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 202 (5.45%)
    17 / 203 (8.37%)
    9 / 201 (4.48%)
    Infections and infestations
    Nasphopharyngitis
         subjects affected / exposed
    11 / 202 (5.45%)
    17 / 203 (8.37%)
    9 / 201 (4.48%)
         occurrences all number
    12
    17
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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