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    Clinical Trial Results:
    Eficacia y seguridad de la rupatadina en la rinitis alérgica persistente y calidad de vida relacionada con la salud en niños de 6 a 11 años: Ensayo clínico aleatorizado, doble ciego y controlado con placebo. “Efficacy and safety of Rupatadine in persistent allergic rhinitis and helath-related quality of life in children age 6-11 years; A randomized, double blind, placebo-controlled clinical trial ”

    Summary
    EudraCT number
    		 2008-005939-15
    Trial protocol
    		 HU   ES  
    Global end of trial date
    10 Feb 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions
    Summary report(s)
    		 Clinical Study Report Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    DC04/RUP/3/08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    J. Uriach y Compañía S.A
    Sponsor organisation address
    Avinguda Camí Reial 51-57, Palau-Solità i Plegamans, Spain, 08184
    Public contact
    Daniel Peris, J. Uriach y Compañía S.A., daniel.peris@noucor.com
    Scientific contact
    Daniel Peris, J. Uriach y Compañía S.A., +34 682 576 455, daniel.peris@noucor.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
    28 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study objective is to assess the efficacy and safety of rupatadine solution over a period of 28 to 42 days in children between 6 and 11 years old with persistent allergic rhinitis. The main efficacy endpoint will be the change in the total score of the patient symptoms (T4SS) over the 28 days of treatment with rupatadine solution (patient diary card reflective 24 hours symptoms, all days including the same visit days with the investigator).
    Protection of trial subjects
    Before being enrolled in the clinical study, subjects/parent/guardian consented to participate after the nature, scope and possible consequences of the clinical study explained in a form understandable to them. The investigator provided the subject and parent/guardian with an information form on the product and the study characteristics that were read to and/or discussed with the subject and parent/guardian in an understandable way. In this document, the patients and their parents/guardians who were willing to consent to participate in this study were informed of the nature, extent, design and conduct of the study and their consent was obtained in writing prior to inclusion to the study schedule. Patients were given the opportunity to ask questions and were informed of their right to withdraw from the study at any time, for any reason. After reading the informed consent document, the subject/parent/guardian gave consent in writing. The subject’s consent confirmed at the time of consent by the personally dated signature of the subject and by the personally dated signature of the person conducting the informed consent discussions. The original signed consent document was retained by the principal investigator. The principal investigator did not undertake any measures specifically required only for the clinical study until valid consent was obtained. The investigator did not include in the study any subject without previously obtaining written consent from him/her or from his/her legal representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2009
    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: 12
    Country: Number of subjects enrolled
    Hungary: 89
    Country: Number of subjects enrolled
    South Africa: 218
    Country: Number of subjects enrolled
    Argentina: 41
    Worldwide total number of subjects
    360
    EEA total number of subjects
    101
    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)
    359
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 445 patients were screened in the study from 31 March 2009 to 16 December 2009 out of whom 360 (80.9%) were randomized to each treatment group (180 patients to the placebo group and 180 patients to the Rupatadine solution (1mg/ml) group).

    Pre-assignment
    Screening details
    		 All children screening activities were required to be completed within 14 days prior to Day 0, unless otherwise specified If children did not reach the score necessary to be randomized, they should have the chance of completing the selection diary during one more week, but being always in the maximum screening period of 14 days.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Both active treatment and placebo were matched in pharmaceutical form, colour transparency and taste in order to keep the double-blind design

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    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 tablet every day

    Arm title
    		 Product test
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rupatadine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral tablet every day

    Number of subjects in period 1
    		Placebo Product test
    Started
    180
    180
    Completed
    161
    164
    Not completed
    19
    16
         Consent withdrawn by subject
    2
    -
         other reasons, not specified
    10
    -
         Adverse event, non-fatal
    1
    -
         unkown
    -
    3
         Lost to follow-up
    -
    2
         Lack of efficacy
    1
    3
         Protocol deviation
    5
    8

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Product test
    Reporting group description
    		 -

    Primary: 28-day average change from baseline of the subjects’ total 4 nasal symptoms score (T4SS)

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    End point title
    		 28-day average change from baseline of the subjects’ total 4 nasal symptoms score (T4SS)
    End point description
    The primary efficacy assessment was the 28-day average change from baseline of the subjects’ total 4 symptoms score (T4SS): (1) nasal congestion, (2) sneezing, (3) rhinorrhea, and (4) itchy nose, mouth throat and/or ears in the ITT population.
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: T4SS
        arithmetic mean (standard deviation)
    4.7 ± 2.1
    4.2 ± 2.2
    Statistical analysis title
    		 Ancova differences
    Comparison groups
    Placebo v Product test
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.018
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Change from baseline in the total 4 symptoms score (T4SS) after 42 days of treatment

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    End point title
    		 Change from baseline in the total 4 symptoms score (T4SS) after 42 days of treatment
    End point description
    Change from baseline in the total 4 symptoms score (T4SS) after 42 days of treatment
    End point type
    Secondary
    End point timeframe
    42 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: T4SS
        arithmetic mean (standard deviation)
    4.5 ± 2.1
    3.9 ± 2.2
    Statistical analysis title
    		 Ancova difference
    Comparison groups
    Placebo v Product test
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.048
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in the Total Symptoms Score

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    End point title
    		 Change from baseline in the Total Symptoms Score
    End point description
    End point type
    Secondary
    End point timeframe
    28 and 42 days of treatment
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: T5SS
        arithmetic mean (standard deviation)
    5.4 ± 2.7
    4.6 ± 2.7
    No statistical analyses for this end point

    Secondary: Change in the daily score for each symptom (DSS)

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    End point title
    		 Change in the daily score for each symptom (DSS)
    End point description
    End point type
    Secondary
    End point timeframe
    28 and 42 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: DSS
        arithmetic mean (standard deviation)
    1.2 ± 0.6
    1.1 ± 0.7
    No statistical analyses for this end point

    Secondary: Mean value of the daily symptom scores (T4SS and T5SS)

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    End point title
    		 Mean value of the daily symptom scores (T4SS and T5SS)
    End point description
    End point type
    Secondary
    End point timeframe
    42 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: t4ss t5ss
        arithmetic mean (standard deviation)
    3.8 ± 2.8
    3.3 ± 2.9
    No statistical analyses for this end point

    Secondary: Time to beginning of action

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    End point title
    		 Time to beginning of action
    End point description
    End point type
    Secondary
    End point timeframe
    NA
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: hours
    12
    12
    No statistical analyses for this end point

    Secondary: Maximum value of the daily score of each symptom (DSSmax

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    End point title
    		 Maximum value of the daily score of each symptom (DSSmax
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: DSSmax
        arithmetic mean (standard deviation)
    2.5 ± 0.7
    2.3 ± 0.8
    No statistical analyses for this end point

    Secondary: Maximum value of the daily total symptom score (T5SSmax).

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    End point title
    		 Maximum value of the daily total symptom score (T5SSmax).
    End point description
    End point type
    Secondary
    End point timeframe
    1 day
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: T5ss
        arithmetic mean (standard deviation)
    9.6 ± 3.1
    8.9 ± 3.1
    No statistical analyses for this end point

    Secondary: Percentage of days during the study period when the maximum daily score was from 0 to 1

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    End point title
    		 Percentage of days during the study period when the maximum daily score was from 0 to 1
    End point description
    End point type
    Secondary
    End point timeframe
    NA
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: percentage
    37
    43
    No statistical analyses for this end point

    Secondary: Percentage of days during the study period when the maximum daily score was 0

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    End point title
    		 Percentage of days during the study period when the maximum daily score was 0
    End point description
    End point type
    Secondary
    End point timeframe
    NA
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: percentage
    6
    11
    No statistical analyses for this end point

    Secondary: patients requiring rescue medication

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    End point title
    		 patients requiring rescue medication
    End point description
    End point type
    Secondary
    End point timeframe
    42 days
    End point values
    		 Placebo Product test
    Number of subjects analysed
    180
    180
    Units: patients
    5
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All serious adverse events were reported by the investigator to the monitor responsible for the clinical trial or to the Manager of Drug Safety at J. Uriach y Compañía, S.A. within 24hours after their knowledge.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    nk
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Test product
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Test product
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 180 (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: 2%
    Non-serious adverse events
    		 Placebo Test product
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 180 (30.00%)
    67 / 180 (37.22%)
    Injury, poisoning and procedural complications
    unknown
         subjects affected / exposed
    1 / 180 (0.56%)
    5 / 180 (2.78%)
         occurrences all number
    1
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 180 (5.56%)
    23 / 180 (12.78%)
         occurrences all number
    10
    24
    General disorders and administration site conditions
    unk
         subjects affected / exposed
    2 / 180 (1.11%)
    5 / 180 (2.78%)
         occurrences all number
    2
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 180 (0.56%)
    5 / 180 (2.78%)
         occurrences all number
    8
    9
    unk
         subjects affected / exposed
    7 / 180 (3.89%)
    4 / 180 (2.22%)
         occurrences all number
    8
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 180 (3.89%)
    7 / 180 (3.89%)
         occurrences all number
    18
    15
    Epistaxis
         subjects affected / exposed
    5 / 180 (2.78%)
    1 / 180 (0.56%)
         occurrences all number
    18
    15
    UNK
         subjects affected / exposed
    6 / 180 (3.33%)
    7 / 180 (3.89%)
         occurrences all number
    18
    15
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 180 (0.56%)
    4 / 180 (2.22%)
         occurrences all number
    4
    7
    unk
         subjects affected / exposed
    3 / 180 (1.67%)
    3 / 180 (1.67%)
         occurrences all number
    4
    7
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 180 (1.11%)
    6 / 180 (3.33%)
         occurrences all number
    27
    26
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 180 (1.67%)
    5 / 180 (2.78%)
         occurrences all number
    27
    26
    Pharyngitis
         subjects affected / exposed
    3 / 180 (1.67%)
    4 / 180 (2.22%)
         occurrences all number
    27
    26
    UNK
         subjects affected / exposed
    19 / 180 (10.56%)
    11 / 180 (6.11%)
         occurrences all number
    26
    27

    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
    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.

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