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    Clinical Trial Results:
    A Phase III, multicentre, parallel-group, randomized, placebo-controlled, double-blind clinical trial to study the efficacy and safety of desloratadine in Japanese subjects with chronic urticaria

    Summary
    EudraCT number
    2017-000608-13
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    13 Mar 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    4117-201
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01916967
    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
    13 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 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 chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.
    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
    27 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: 239
    Worldwide total number of subjects
    239
    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)
    11
    Adults (18-64 years)
    205
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants with chronic urticaria of at least 12 years of age were enrolled in this trial.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Desloratadine 5 mg
    Arm description
    Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    Other name
    MK-4117
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg Desloratadine administered orally once daily for 2 weeks

    Arm title
    Desloratadine 10 mg
    Arm description
    Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    Other name
    MK-4117
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg Desloratadine administered orally once daily for 2 weeks

    Arm title
    Placebo
    Arm description
    Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for Desloratadine administered orally once daily for 2 weeks

    Number of subjects in period 1
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Started
    80
    79
    80
    Completed
    80
    78
    71
    Not completed
    0
    1
    9
         Protocol deviation
    -
    1
    -
         Physician decision
    -
    -
    1
         Lack of efficacy
    -
    -
    6
         Adverse event, non-fatal
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks

    Reporting group values
    Desloratadine 5 mg Desloratadine 10 mg Placebo Total
    Number of subjects
    80 79 80 239
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    4 3 4 11
        Adults (18-64 years)
    67 66 72 205
        From 65-84 years
    9 10 4 23
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    38.4 ± 16.3 40.6 ± 15.8 39.3 ± 15.2 -
    Gender Categorical
    Units: Subjects
        Female
    59 48 45 152
        Male
    21 31 35 87

    End points

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    End points reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks

    Subject analysis set title
    Desloratadine 5 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

    Subject analysis set title
    Desloratadine 10 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks

    Subject analysis set title
    Desloratadine 5 mg→Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participant received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week

    Primary: Change from baseline in the sum score of pruritus/itch and rash assessed by investigator at Week 2

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    End point title
    Change from baseline in the sum score of pruritus/itch and rash assessed by investigator at Week 2
    End point description
    The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline Visit and Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    -3.19 (-3.56 to -2.83)
    -3.16 (-3.52 to -2.79)
    -2.02 (-2.4 to -1.65)
    Statistical analysis title
    Difference LS means: Desloratadine 5 mg vs Placebo
    Statistical analysis description
    Model with terms of visit, visit by treatment, visit by age strata, visit by severity interactions; visit treated as a categorical variable
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Constrained Longitudinal Data Analysis
    Parameter type
    Difference in LS means
    Point estimate
    -1.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.69
         upper limit
    -0.65
    Statistical analysis title
    Difference LS means: Desloratadine 5 mg vs Placebo
    Statistical analysis description
    Model with terms of visit, visit by treatment, visit by age strata, visit by severity interactions; visit treated as a categorical variable
    Comparison groups
    Desloratadine 10 mg v Placebo
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Constrained Longitudinal Data Analysis
    Parameter type
    Difference in LS means
    Point estimate
    -1.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.66
         upper limit
    -0.61

    Primary: Number of participants who experienced at least one adverse event (AE)

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    End point title
    Number of participants who experienced at least one adverse event (AE) [1]
    End point description
    An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 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 preexisting condition that is temporally associated with the use of the study drug, is also an AE. The population analyzed consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
    End point type
    Primary
    End point timeframe
    Up to 4 weeks (Up to 2 weeks after last dose of study drug)
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo Desloratadine 5 mg→Placebo
    Number of subjects analysed
    80
    79
    79
    1
    Units: Participants
        number (not applicable)
    24
    18
    16
    0
    No statistical analyses for this end point

    Primary: Number of participants who discontinued study drug due to an AE

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    End point title
    Number of participants who discontinued study drug due to an AE [2]
    End point description
    An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 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 preexisting condition that is temporally associated with the use of the study drug, is also an AE. The population analyzed consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo Desloratadine 5 mg→Placebo
    Number of subjects analysed
    80
    79
    79
    1
    Units: Participants
        number (not applicable)
    0
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1

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    End point title
    Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1
    End point description
    The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -2.57 (-2.91 to -2.23)
    -2.75 (-3.09 to -2.41)
    -0.8 (-1.14 to -0.46)
        Change from Baseline at Week 1
    -3.01 (-3.34 to -2.68)
    -3.16 (-3.5 to -2.83)
    -1.39 (-1.72 to -1.06)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2

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    End point title
    Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2
    End point description
    The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -2.62 (-2.97 to -2.27)
    -2.72 (-3.07 to -2.37)
    -0.61 (-0.95 to -0.26)
        Change from Baseline at Week 1
    -2.98 (-3.35 to -2.61)
    -3.13 (-3.5 to -2.76)
    -1.38 (-1.75 to -1.01)
        Change from Baseline at Week 2
    -3.17 (-3.56 to -2.77)
    -3.21 (-3.6 to -2.81)
    -1.91 (-2.31 to -1.5)
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2
    End point description
    The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -2.31 (-2.63 to -2)
    -2.61 (-2.93 to -2.29)
    -0.99 (-1.31 to -0.67)
        Change from Baseline at Week 1
    -2.65 (-2.97 to -2.33)
    -2.98 (-3.3 to -2.66)
    -1.44 (-1.76 to -1.12)
        Change from Baseline at Week 2
    -2.94 (-3.28 to -2.61)
    -2.91 (-3.25 to -2.57)
    -1.98 (-2.33 to -1.64)
    No statistical analyses for this end point

    Secondary: Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2

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    End point title
    Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2
    End point description
    The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Participants
    number (not applicable)
        Day 3
    54
    55
    15
        Week 1
    54
    58
    32
        Week 2
    59
    53
    38
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2

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    End point title
    Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
    End point description
    Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -2.37 (-2.74 to -2)
    -2.73 (-3.1 to -2.36)
    -0.5 (-0.87 to -0.13)
        Change from Baseline at Week 1
    -2.53 (-2.91 to -2.15)
    -2.85 (-3.24 to -2.47)
    -1.27 (-1.65 to -0.88)
        Change from Baseline at Week 2
    -2.85 (-3.3 to -2.41)
    -2.97 (-3.42 to -2.51)
    -1.75 (-2.23 to -1.27)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2

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    End point title
    Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2
    End point description
    Participants assessed the degree of their pruritus/itching using a 100mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -35.94 (-41.91 to -29.97)
    -39.6 (-45.61 to -33.6)
    -5.22 (-11.19 to 0.75)
        Change from Baseline at Week 1
    -40.82 (-46.55 to -35.09)
    -48.82 (-54.6 to -43.03)
    -15.88 (-21.63 to -10.13)
        Change from Baseline at Week 2
    -45.86 (-51.96 to -39.75)
    -45.01 (-51.17 to 38.84)
    -25.24 (-31.52 to -18.97)
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
    End point description
    Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. The population analyzed consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    80
    79
    80
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Day 3
    -2.21 (-2.57 to -1.85)
    -2.31 (-2.67 to -1.94)
    -0.77 (-1.13 to -0.4)
        Change from Baseline at Week 1
    -2.15 (-2.5 to -1.81)
    -2.43 (-2.77 to -2.08)
    -1.17 (-1.52 to -0.83)
        Change from Baseline at Week 2
    -2.51 (-2.88 to -2.13)
    -2.45 (-2.83 to -2.06)
    -1.7 (-2.11 to -1.29)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2

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    End point title
    Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2
    End point description
    The DLQI is a 10 item questionnaire measuring how much participant skin problems have affected their life. Responses to questions ranged from 0=Not at all to 3=Very much. The DLQI consists of 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3),Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated. The population analyzed was all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for DLQI.
    End point type
    Secondary
    End point timeframe
    Baseline Visit and Week 1 Visit, Week 2 Visit
    End point values
    Desloratadine 5 mg Desloratadine 10 mg Placebo
    Number of subjects analysed
    79
    77
    77
    Units: Score on a scale
    least squares mean (confidence interval 95%)
        Change from Baseline at Week 1
    -3.82 (-4.52 to -3.12)
    -4.08 (-4.78 to -3.37)
    -1.6 (-2.31 to -0.89)
        Change from Baseline at Week 2
    -4.1 (-4.83 to -3.38)
    -4.01 (-4.74 to -3.28)
    -2.53 (-3.28 to -1.78)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 4 weeks (Up to 2 weeks after last dose of study drug)
    Adverse event reporting additional description
    All participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.
    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 received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

    Reporting group title
    Desloratadine 10 mg
    Reporting group description
    Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks

    Reporting group title
    Desloratadine 5 mg→Placebo
    Reporting group description
    Participant received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week

    Serious adverse events
    Desloratadine 5 mg Desloratadine 10 mg Placebo Desloratadine 5 mg→Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Desloratadine 5 mg Desloratadine 10 mg Placebo Desloratadine 5 mg→Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 80 (12.50%)
    8 / 79 (10.13%)
    5 / 79 (6.33%)
    0 / 1 (0.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    3 / 80 (3.75%)
    5 / 79 (6.33%)
    3 / 79 (3.80%)
    0 / 1 (0.00%)
         occurrences all number
    3
    6
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 80 (10.00%)
    3 / 79 (3.80%)
    2 / 79 (2.53%)
    0 / 1 (0.00%)
         occurrences all number
    8
    3
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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