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    Clinical Trial Results:
    Double Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Intermittent Allergic Rhinitis (IAR)

    Summary
    EudraCT number
    		 2005-005449-20
    Trial protocol
    		 FI   PT   ES   DE   HU   SE   GR   DK   IT   BE   Outside EU/EEA  
    Global end of trial date
    21 Nov 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P04683
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00406783
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-4117-174
    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
    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
    21 Nov 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent 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
    28 Aug 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Sweden: 35
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    France: 109
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Greece: 17
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    Italy: 68
    Country: Number of subjects enrolled
    Canada: 134
    Country: Number of subjects enrolled
    Russian Federation: 48
    Country: Number of subjects enrolled
    Turkey: 21
    Worldwide total number of subjects
    547
    EEA total number of subjects
    344
    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)
    20
    Adults (18-64 years)
    519
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study sites were part of the Global Allergy and Asthma European Network (GA2LEN).

    Pre-assignment
    Screening details
    		 Approximately eight subjects were to be enrolled at each site, but up to approximately 30 subjects could be enrolled at each site with the sponsor’s approval.

    Period 1
    Period 1 title
    Treatment (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
    		 Desloratadine 5 mg, oral, tablet, once daily for 15 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    Other name
    SCH 34117, Aerius, MK-4117
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Desloratadine 5 mg, oral, tablet, once daily for 15 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Desloratadine, oral, tablet, once daily for 15 days

    Arm title
    		 Placebo
    Arm description
    		 Placebo to Desloratadine, oral, tablet, once daily for 15 days
    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 to desloratadine, oral, tablet once daily for 15 days

    Number of subjects in period 1
    		Desloratadine 5 mg Placebo
    Started
    276
    271
    Completed
    262
    256
    Not completed
    14
    15
         Did not meet protocol eligibility
    -
    1
         Consent withdrawn by subject
    1
    4
         Adverse event, non-fatal
    4
    4
         Lost to follow-up
    3
    -
         Lack of efficacy
    2
    3
         Protocol deviation
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 Desloratadine 5 mg, oral, tablet, once daily for 15 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to Desloratadine, oral, tablet, once daily for 15 days

    Reporting group values
    		 Desloratadine 5 mg Placebo Total
    Number of subjects
    		 276 271 547
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 12 8 20
        Adults (18-64 years)
    		 262 257 519
        From 65-84 years
    		 2 6 8
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.8 ± 12 34.6 ± 12.8 -
    Gender categorical
    Units: Subjects
        Female
    		 154 164 318
        Male
    		 122 107 229

    End points

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    End points reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 Desloratadine 5 mg, oral, tablet, once daily for 15 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to Desloratadine, oral, tablet, once daily for 15 days

    Primary: The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15

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    End point title
    		 The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15
    End point description
    AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).
    End point type
    Primary
    End point timeframe
    Baseline and Days 1 to 15
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    271 [1]
    265 [2]
    Units: Scores on a scale
        least squares mean (standard error)
    -3.01 ± 0.21
    -2.13 ± 0.2
    Notes
    [1] - All randomized participants with a non-missing baseline and at least some post-baseline data.
    [2] - All randomized participants with a non-missing baseline and at least some post-baseline data.
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Difference in the least squares means between change from baseline in AM/PM PRIOR (reflective) T5SS for participants taking desloratadine over Day 1 to Day 15 of treatment vs. change from baseline in AM/PM PRIOR (reflective) T5SS for participants taking placebo over Day 1 to Day 15 of treatment. Negative differences are in favor of the desloratadine treatment group in the comparison.
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.31
         upper limit
    		 -0.46
    Notes
    [3] - LS means, SEM, and 95% Confidence Intervals are obtained from an ANOVA model with treatment and site effects.

    Secondary: Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit

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    End point title
    		 Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit
    End point description
    The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.
    End point type
    Secondary
    End point timeframe
    Baseline and 15 days
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    250 [4]
    248 [5]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.1 ± 0.1
    -0.73 ± 0.1
    Notes
    [4] - Participant >=18 years of age and where available in the local language.
    [5] - Participants >=18 years of age and where available in the local language.
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Difference in the least squares means between change from baseline in RQLQ-S for participants taking desloratadine at Day 15 of treatment vs. change from baseline in RQLQ-S for participants taking placebo at Day 15 of treatment. Negative differences are in favor of the desloratadine treatment group in the comparison.
    Comparison groups
    Desloratadine 5 mg v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.58
         upper limit
    		 -0.17
    Notes
    [6] - LS means, SEM, and 95% Confidence Intervals are obtained from an ANOVA model with treatment and site effects.

    Other pre-specified: Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE

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    End point title
    		 Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE
    End point description
    AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).
    End point type
    Other pre-specified
    End point timeframe
    Baseline
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    271 [7]
    265 [8]
    Units: Scores on a scale
        least squares mean (standard error)
    8.5 ± 0.14
    8.33 ± 0.14
    Notes
    [7] - All participants with a non-missing baseline and at least some post-baseline data.
    [8] - All particants with a non-missing baseline and at least some post-baseline data.
    No statistical analyses for this end point

    Other pre-specified: Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE)

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    End point title
    		 Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE)
    End point description
    The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.
    End point type
    Other pre-specified
    End point timeframe
    Baseline
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    250 [9]
    248 [10]
    Units: Scores on a scale
        least squares mean (standard error)
    2.96 ± 0.08
    2.8 ± 0.08
    Notes
    [9] - All participants >=18 years of age and where available in the local language.
    [10] - All participants >=18 years of age and where available in the local language.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 15
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Desloratadine 5 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 276 (0.00%)
    0 / 271 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Desloratadine 5 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 276 (6.52%)
    17 / 271 (6.27%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 276 (6.52%)
    17 / 271 (6.27%)
         occurrences all number
    23
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2006
    This amendment provided an updated version of a study questionnaire.
    05 Jun 2007
    This amendment changed criteria for subject discontinuation from the study and changed the grading scale for a study assessment.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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