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    Summary
    EudraCT Number:2014-004774-42
    Sponsor's Protocol Code Number:MK-0476-519
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004774-42
    A.3Full title of the trial
    A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects with Seasonal Allergic Rhinitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects with Seasonal Allergic Rhinitis.
    A.3.2Name or abbreviated title of the trial where available
    A Phase III Placebo-controlled efficacy Study of MK-0476 in Pediatric SAR
    A.4.1Sponsor's protocol code numberMK-0476-519
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01857063
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressKITANOMARU SQUARE, 1-13-12, Kudan-kita
    B.5.3.2Town/ cityChiyoda-ku Tokyo
    B.5.3.3Post code102-8667
    B.5.3.4CountryJapan
    B.5.4Telephone number+81-3-6272-1844
    B.5.6E-mailyoichi.inoue@merck.com
    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 nameMontelukast Sodium
    D.3.2Product code MK-0476
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNMontelukast Sodium
    D.3.9.1CAS number 18559-94-9
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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 placeboChewable tablet
    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
    Seasonal allergic rhinitis for pediatrics
    E.1.1.1Medical condition in easily understood language
    Seasonal allergies in children
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 efficacy of MK-0476 5 mg CT in pediatric subject with seasonal allergic rhinitis.
    To evaluate the safety and tolerability of treatment for 7 days with MK-0476 5mg CT in pediatric seasonal allergic rhinitis.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MK-0476 in subjects with seasonal allergic rhinitis in the following endpoints:
    The change from baseline of the weighted TNSS (weighted of 2:1:1 for nasal congestion, nasal discharge, and sneezing, respectively) averaged during 3 hours of exposure.
    The change from baseline of each nasal symptom score averaged during 3 hours of exposure.
    The change from baseline of the TNSS at 30, 60, 90, 120, 150, and 180 minutes after entering the chamber room.
    The change from baseline of the weighted TNSS at 30, 60, 90, 120, 150, and 180 minutes after entering the chamber room.
    The change from baseline of each nasal symptom score at 30, 60, 90, 120, 150, and 180 minutes after entering the chamber room.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Buccal swabs for Future Biomedical Research:

    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    Japanese Male and Female subjects with the diagnosis of seasonal allergic rhinitis between the ages of 10 and 15 y.o. (inclusive) will be enrolled in this trial.
    E.4Principal exclusion criteria
    Is diagnosed as either acute rhinitis*, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilic rhinitis).

    *The subject develops acute nasal infections such as acute rhinitis during screening period cannot be randomized at visit 3.

    Has nasal polyps and/or polyp-like findings that would interfere with evaluating nasal congestion symptom.

    Is diagnosed AR to any allergen other than JC pollen by examinations.

    Has started hyposensitization therapy or non- specific immunotherapy within 6
    months prior to Visit 1 be in treatment

    Has a past or present medical history of bronchial asthma.

    As for the patients with the experience of allergen-challenge exposure study in the past, has IgE-antibody assay at Visit 1 ≥ 2 times of that was obtained before the past allergen-challenge exposure.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline of the TNSS averaged during 3 hours of exposure. It will be analyzed using a LDA model. The analysis model will include TNSS at baseline as a covariate, sequence, treatment and period as fixed effects and subject as a random effect. The treatment difference in the change from baseline of the TNSS will be estimated and tested with this model. The secondary hypotheses will be evaluated using a LDA model in the same manner. The key efficacy analysis is summarized in Table 7.

    Nasal congestion, nasal discharge and sneezing are the three major characteristics of allergic rhinitis, and the sum of these symptoms score, TNSS, has been established as evaluation index for allergic rhinitis. To evaluate the efficacy of MK-0476 in this study, the averaged TNSS during 3 hours is settled as a primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to above
    E.5.2Secondary end point(s)
    The change from baseline of the weighted TNSS averaged during 3 hours of exposure
    The change from baseline of each nasal symptom score averaged during 3 hours of exposure
    The change from baseline at 30, 60, 90, 120, 150, and 180 minutes after entering the chamber room in:
    TNSS, Weighted TNSS, Each nasal symptom score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to above
    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 No
    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 No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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.1.1Number of subjects for this age range: 220
    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.1.1.5.1Number of subjects for this age range: 110
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 110
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of treatment each subject will be followed up for 14 days.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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