Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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 Persistent Allergic Rhinitis (PER)

    Summary
    EudraCT number
    		 2005-005450-45
    Trial protocol
    		 FI   PT   ES   DE   HU   SE   GR   DK   IT   BE   NL   Outside EU/EEA  
    Global end of trial date
    03 Apr 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    P04684
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00405964
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-4117-175
    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
    03 Apr 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare the efficacy and safety of desloratadine with placebo in the symptomatic treatment of participants 12 years and older with persistent allergic rhinitis (PER) .
    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
    Spain: 25
    Country: Number of subjects enrolled
    Sweden: 31
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    Finland: 21
    Country: Number of subjects enrolled
    France: 111
    Country: Number of subjects enrolled
    Germany: 86
    Country: Number of subjects enrolled
    Hungary: 48
    Country: Number of subjects enrolled
    Italy: 87
    Country: Number of subjects enrolled
    Canada: 194
    Country: Number of subjects enrolled
    Russian Federation: 101
    Country: Number of subjects enrolled
    Turkey: 2
    Worldwide total number of subjects
    716
    EEA total number of subjects
    419
    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)
    18
    Adults (18-64 years)
    689
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled from 12 countries in Europe.

    Pre-assignment
    Screening details
    		 Approximately 10 participants were to be enrolled at each site, but up to approximately 30 participants 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
    		 5-mg Desloratadine tablet, oral, once daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desloratadine
    Investigational medicinal product code
    Other name
    SCH 34117, Aerius
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-mg Desloratadine tablet, oral, once daily for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablet to desloratadine 5 mg, oral, once daily for 12 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 to desloratadine, tablet, oral, once daily for 12 weeks

    Number of subjects in period 1
    		Desloratadine 5 mg Placebo
    Started
    360
    356
    Completed
    301
    261
    Not completed
    59
    95
         Consent withdrawn by subject
    19
    23
         Adverse event, non-fatal
    7
    16
         Lost to follow-up
    5
    5
         Lack of efficacy
    17
    45
         Protocol deviation
    11
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 5-mg Desloratadine tablet, oral, once daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet to desloratadine 5 mg, oral, once daily for 12 weeks

    Reporting group values
    		 Desloratadine 5 mg Placebo Total
    Number of subjects
    		 360 356 716
    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)
    		 9 9 18
        Adults (18-64 years)
    		 348 341 689
        From 65-84 years
    		 3 6 9
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ± 12.1 33.9 ± 12.3 -
    Gender categorical
    Units: Subjects
        Female
    		 208 198 406
        Male
    		 152 158 310

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 5-mg Desloratadine tablet, oral, once daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablet to desloratadine 5 mg, oral, once daily for 12 weeks

    Primary: Change From Baseline in Participant's AM/PM PRIOR (Reflective) Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment

    		 Close Top of page
    End point title
    		 Change From Baseline in Participant's AM/PM PRIOR (Reflective) Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment
    End point description
    AM/PM PRIOR (the participant’s status over previous 12 hours [reflective]) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
    End point type
    Primary
    End point timeframe
    Baseline and Days 1-29
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    355 [1]
    351 [2]
    Units: Units on a scale
    least squares mean (standard error)
        Baseline
    9.63 ± 0.13
    9.55 ± 0.12
        Days 1-29
    -3.76 ± 0.22
    -2.87 ± 0.21
    Notes
    [1] - All randomized participants with non-missing baseline and at least some postbaseline data.
    [2] - All randomized participants with non-missing baseline and at least some postbaseline data.
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Difference in the least squares means between change from baseline in AM/PM PRIOR T5SS for participants taking desloratadine over Day 1 to Day 29 of treatment vs. change from baseline in AM/PM PRIOR (Reflective) T5SS for participants taking placebo over Day 1 to Day 29 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
    706
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 -0.46
    Notes
    [3] - Analyses were performed using an ANOVA, extracting sources of variation due to treatment and site.

    Secondary: Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days

    		 Close Top of page
    End point title
    		 Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days
    End point description
    The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 29
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    313 [4]
    289 [5]
    Units: Units on a scale
    least squares mean (standard error)
        Baseline
    3.3 ± 0.08
    3.15 ± 0.08
        Day 29
    -1.35 ± 0.1
    -0.95 ± 0.1
    Notes
    [4] - All randomized participants with non-missing baseline and at least some postbaseline data.
    [5] - All randomized participants with non-missing baseline and at least some postbaseline data.
    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 29 of treatment vs. change from baseline in RQLQ-S for participants taking placebo at Day 29 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
    602
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 -0.2
    Notes
    [6] - Analyses were performed using an ANOVA, extracting sources of variation due to treatment and site.

    Secondary: Change From Baseline in Participant's AM/PM PRIOR (Reflective) T5SS Over Days 1 to 85 of Treatment

    		 Close Top of page
    End point title
    		 Change From Baseline in Participant's AM/PM PRIOR (Reflective) T5SS Over Days 1 to 85 of Treatment
    End point description
    AM/PM PRIOR (the participant’s status over previous 12 hours [reflective]) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 1-85
    End point values
    		 Desloratadine 5 mg Placebo
    Number of subjects analysed
    355 [7]
    351 [8]
    Units: Units on a scale
    least squares mean (standard error)
        Baseline
    9.63 ± 0.13
    9.55 ± 0.12
        Days 1-85
    -4.5 ± 0.23
    -3.61 ± 0.23
    Notes
    [7] - All randomized participants with non-missing baseline and at least some postbaseline data.
    [8] - All randomized participants with non-missing baseline and at least some postbaseline data.
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Difference in the least squares means between change from baseline in AM/PM PRIOR T5SS for participants taking desloratadine over Day 1 to Day 85 of treatment vs. change from baseline in AM/PM PRIOR (Reflective) T5SS for participants taking placebo over Day 1 to Day 85 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
    706
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 -0.43
    Notes
    [9] - Analyses were performed using an ANOVA, extracting sources of variation due to treatment and site.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Desloratadine 5 mg
    Reporting group description
    		 All randomized participants who received at least one dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    		 All randomized participants who received at least one dose of study drug.

    Serious adverse events
    		 Desloratadine 5 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 360 (0.28%)
    2 / 356 (0.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 360 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 360 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal
         subjects affected / exposed
    0 / 360 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 360 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    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
    60 / 360 (16.67%)
    48 / 356 (13.48%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 360 (6.94%)
    37 / 356 (10.39%)
         occurrences all number
    45
    63
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    38 / 360 (10.56%)
    17 / 356 (4.78%)
         occurrences all number
    44
    18

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2006
    This amendment included an updated version of a study questionnaire.
    05 Jun 2007
    This amendment includes changes to study evaluations, criteria for subject discontinuation, and prohibited medications.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 11:05:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA