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    Summary
    EudraCT Number:2008-005939-15
    Sponsor's Protocol Code Number:DC04/RUP/3/08
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2008-005939-15
    A.3Full title of the trial
    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 ”
    A.4.1Sponsor's protocol code numberDC04/RUP/3/08
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJ. Uriach y Compañía, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRupatadina
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRupatadina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeChemical origin
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rinitis Alérgica Persistente

    Persistent Allergic Rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10034382
    E.1.2Term Perennial allergic rhinitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039776
    E.1.2Term Seasonal allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).
    E.2.2Secondary objectives of the trial
    Change from baseline in the total score after 42 days of treatment.
    Change in the total score during the 28 and 42 days of treatment.
    Change in the daily score for each symptom from baseline during 28 and 42 days.
    Mean value of the daily total score of symptoms
    Time to beginning of action (first week).
    Maximum value of the daily score of each symptom
    Maximum value of the total daily symptom score
    Percentage of days during the study period when the maximum daily score was from 0 to 1
    Percentage of days during the study period when the maximum daily score was 0
    Percentage of patients requiring rescue medication.
    Assessment of instantaneous symptoms severity (both patient and investigator)
    Assessment of instantaneous effectiveness (both patient and investigator)
    Paediatric Rhinoconjuntivitis Quality of Life (PRQLQ)

    Safety measurements will include:
    Adverse Events incidence
    Related Adverse Events incidence
    Serious Adverse Events incidence
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Boys and girls between 6 and 11 years old, inclusive, at screening.
    (2) Weight ??16 Kg.
    (3) Documented history of persistent allergic rhinitis of at least 12 months before the selection visit.
    (4) Skin Prick test positive of 3 mm greater than the negative control to at least one of the following: housedust mites (Der p 1 and der f 1), fungal spores (alternaria, aspegillus, cladosporium), and Grass pollens (bermuda and Rye); and symptomatic for more than 4 weeks to the allergen to which they are positive (ARIA guideline).
    (5) Results of standard laboratory tests within acceptable limits as assessed by investigator.
    (6) Girls of child bearing potential should have a negative pregnancy test at the time of inclusion. In addition, if sexually active, they must use contraceptive measures (e.g oral contraceptives or double-barrier contraception). The commitment of the patient to use these measures while participating in this clinical trial will be considered as sufficient.
    (7) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Bazzet?s correction must be normal (not prolonged). The values considered to be normal are ? 430 msec for boys and ? 450 msec for girls.
    (8) Children who have written consent from their parent/guardian to participate in the study. Children who are considered mature enough to understand an assent form will be invited to give written assent.
    E.4Principal exclusion criteria
    (1) Clinically relevant abnormal physical findings which could interfere with the objectives of the study.
    (2) Clinically relevant abnormal laboratory values indicative of physical illness.
    (3) Ascertained of presumptive hypersensitivity to the active principle and/or formulation ingredients of the tested compounds such as children with lactose intolerance.
    (4) Children under any systemic or topical medication for AR and/or an inferior wash-out period as stated as follows: corticosteroids (depot, 90 days; systemic 30 days; dermatologic 14 days), cromones (14 days), antihistamines (astemizole, 90 days; ketotifen, 10 days; nasal and long-acting oral, 10 days; short-acting oral, 12-48 hours; ocular, 3 days), decongestants (1-3 days), leukotriene inhibitors (10 days), herbal remedies (3 days), systemic antibiotics (14 days), anticholinergic (7 days), any potential inhibitor of CYP3A4 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, (28 days), ophthalmic non-steroidal anti-inflammatory drugs (3 days), nasal-ophthalmic wash solutions (12 h) and immunotherapy.
    Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to first study dosing.
    Child with mild asthma treated with inhaled bronchodilators or inhaled corticosteroids of ? 800 mcg/day of budesonide or beclomethasone, or with ? 500 mcg/day of fluticasone will be allowed in the study upon specific sponsor approval.
    (5) Children taking medication that is known to interact significantly with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazapine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, erythromycin, ketoconazole as well as grapefruit juice.
    (6) Children that after review of their medical history, is considered by the investigator as unresponsive to antihistaminic treatment.
    (7) Children whose health could be harmed by their participation in the study at investigator criteria.
    (8) Girl who is pregnant or lactating.
    (9) History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study.
    (10) Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
    (11) History of chronic nasal or upper respiratory symptoms/disorders, nasal polyps and significant deviation of nasal septum.
    (12) History of non-allergic rhinitis (vasomotor, infectious, drug-induced, etc).
    (13) Chronic sinusitis or severe bronchial asthma.
    (14) Respiratory infection in the last 30 days before the study start.
    (15) Children unable to comply with the study requirements (attendance to visits), unable to complete the patient diary and take the study treatment, or children that should have to travel to another geographic area during the course of the study.
    (16) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
    (17) Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
    (18) Participation in the evaluation of any drug within 3 months prior to the start of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the Total 4 Symptoms Score of the patient (T4SS) over 28 days of treatment (reflective 24 hours symptoms assessment).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children from 6 to 11 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 366
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
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