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    Summary
    EudraCT Number:2010-021361-69
    Sponsor's Protocol Code Number:DC01/RUP/2/09
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-16
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-021361-69
    A.3Full title of the trial
    A multicenter, open-label study to assess pharmacokinetics, efficacy, tolerability and safety of Rupatadine in paediatrics patients (2-5 years old) with allergic rhinitis.
    A.4.1Sponsor's protocol code numberDC01/RUP/2/09
    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 Yes
    D.2.1.1.1Trade name Rupatadine
    D.2.1.1.2Name of the Marketing Authorisation holderJ. Uriach & Cía. S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRupatadine
    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 INNRUPATADINE
    D.3.9.1CAS number 158876825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5 to 5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic Rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term 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
    To evaluate the pharmacokinetics of rupatadine after the administration of multiple oral doses of rupatadine over a treatment period of 28 days in children between 2 and 5 years old with allergic rhinitis (AR).

    PK values as follows: volume of distribution of different compartments, total plasma clearance, intercompartmental clearance and absorption rate constant.
    E.2.2Secondary objectives of the trial
    To evaluate efficacy, tolerability and safety after the administration of multiple oral doses of rupatadine over a treatment period of 28 days in children between 2 and 5 years old with allergic rhinitis (AR).

    •Change from baseline in the total score of the patient symptoms (5TSS) to Day 14 (end of treatment), and to Day 28.
    •Change in the daily score for each symptom (DSS) from baseline during 14 and 28 days.
    •Mean value of the daily total score of symptoms (mTSS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1)Boys and girls between 2 and 5 years old, inclusive, at screening.
    (2)Weight 10 Kg.
    (3)Documented history of mild-moderate allergic rhinitis, susceptible to oral antihistamine treatment in the opinion of the investigator.
    (4)5TSS 6 during at least the last 2 days before inclusion.
    (5)Skin Prick test positive of 3 mm greater than the diluent control or a positive ImmunoCAP / RAST test.
    (6)Results of standard laboratory tests within acceptable limits as assessed by investigator.
    (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 Fridericia’s correction must be normal (not prolonged). The values considered to be normal are 450 msec.
    E.4Principal exclusion criteria
    (1) Clinically relevant abnormal physical findings which could interfere with the objectives of the study, or children with disabilities, developmental delay, psychological problems, or behavioural problems.
    (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 (oral and nasal 28 days, topical dermatological 14 days), cromones (14 days), 1st generation antihistamines, like chlorpheniramine, diphenhydramine, mequitazine or ocular, 7 days; 2nd generation, like loratadine, desloratadine, cetirizine, levocetirizine, 7 days, nasal decongestants (1-3 days), leukotriene inhibitors (3 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.
    Inhaled 2 bronchodilators (salbutamol) or long acting (formoterol, salmeterol) are permitted. Children with mild asthma treated with inhaled corticosteroids of ≤ 250 mcg/day for fluticasone  400 mcg/day for budesonide or  160 mcg/day for ciclesonide will be allowed in the study.
    (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, antivirals, erythromycin, ketoconazole as well as grapefruit juice.
    (6) Children that after review of their medical history, are 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) History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study.
    (9) Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
    (10) History of chronic nasal or upper respiratory symptoms/disorders, nasal polyps and significant deviation of nasal septum.
    (11) History of non-allergic rhinitis (vasomotor, infectious, obstructive nasal polyposis, drug-induced, etc).
    (12) Chronic sinusitis or severe bronchial asthma.
    (13) Any ear, nose, or throat (ENT) infection in the last 15 days before the baseline visit or any associated ENT disease or temperature  38.5ºC at the baseline visit.
    (14) Children unable to comply with the study requirements (attendance to visits), unable (and their parents) to complete the patient diary and take the study treatment, or children who have to travel to another geographic area during the course of the study.
    (15) Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
    E.5 End points
    E.5.1Primary end point(s)
    The main PK endpoint will be the evaluation of population PK, evaluated in terms of volume of distribution of different compartments, total plasma clearance, intercompartmental clearance and absorption rate constant
    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 Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetic
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 No
    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
    paediatrics patients (2-5 years old) with allergic rhinitis
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 40
    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 Decision2010-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-30
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