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    Summary
    EudraCT Number:2014-004921-41
    Sponsor's Protocol Code Number:P06332
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-02-24
    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 number2014-004921-41
    A.3Full title of the trial
    Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis
    A.3.2Name or abbreviated title of the trial where available
    Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray
    A.4.1Sponsor's protocol code numberP06332
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01135134
    A.5.4Other Identifiers
    Name:-Number:MK-0887-174
    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 SponsorCorporation Schering-Plough K.K.
    B.1.3.4CountryJapan
    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 supportSchering-Plough K.K.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough K.K.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street Address2-3-7 Hiranomachi, Osaka
    B.5.3.2Town/ cityChuo-ku
    B.5.3.3Post code541-0046
    B.5.3.4CountryJapan
    B.5.4Telephone number+813 6901 1320
    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 Nasonex
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough K.K.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameMometasone furoate nasal spray (Nasonex)
    D.3.2Product code MK 0887, SCH 32088
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone Furoate
    D.3.9.1CAS number 83919-23-7
    D.3.9.2Current sponsor codeMK-0887 and SCH 32088
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboNasal spray
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    perennial allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    perennial allergic rhinitis
    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 assess the efficacy of mometasone furoate (MF) nasal spray in pediatric subjects with perennial allergicrhinitis based on the primary endpoint, i.e., the change from baseline in the total score of 4 nasal symptoms (sneezing, rhinorrhea, nasal congestion and nasal itching symptom score) after 2 weeks(or at discontinuation)of treatment.
    E.2.2Secondary objectives of the trial
    (1) a)To compare the efficacy of MF and placebo for total nasal symptom scores after one week of treatment and b) to compare the efficacy of MF and placebo for individual symptom scores*1 (sneezing, rhinorrhea, nasal congestion, and nasal itching), individual nasal finding score (swelling of inferior nasal concha mucosa, coloring of inferior nasal concha mucosa, rhinorrhea discharged), interference with daily activities, and global improvement (moderate and remarkable improvement) after one week and 2 weeks of treatment.
    (2) To compare the difference between MF and placebo in incidence and number of adverse events (AEs) and adverse drug reactions (ADRs) and changes in laboratory values, including predefined clinically relevant changes.
    (*1; Based on a modified standard of ‘Practical Guideline for the Management of Allergic Rhinitis in Japan’ )
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, according to the classification of severity in the Practical Guideline for the Management of Allergic Rhinitis in Japan (partial revision, 2009) as well as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), after the pretreatment observation period. As a rule, subjects should fulfill above criteria at the time of obtaining informed consent.
    (2) Subjects confirmed to be allergic to non-seasonal environmental antigens based on the tests.
    (3) Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
    (4) Subjects whose parents/legal representatives can provide written informed consent.
    (5) Subjects who can make entries in the nasal allergy diary or have a parent/legal representative who can make entries.
    E.4Principal exclusion criteria
    (1) Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) judged by the investigator to require treatment at the time of registration
    (2) Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
    (3) Subjects with repeated epistaxis
    (4) Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
    (5) Subjects with a history of hypersensitivity to steroids and other components of the study drug
    (6) Female subjects with positive pregnancy test (conducted only in subjects 7 years of age and older)
    (7) Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
    (8) Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the study period (at any time from the start of the observation
    period to the end of treatment).
    (9) Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
    (10) Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
    (11) Subjects who develop a disease affecting nasal symptoms (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis) in the 7 days before registration in the study.
    (12) Subjects who have previously received MFNS.
    (13) Subjects who have taken of an investigational drug within 120 days (4 months) before the day of informed consent.
    (14) Subjects for whom the period of discontinuation of previous treatment before the start of study
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline in the total score of 4 nasal symptoms (sneezing, rhinorrhea, nasal congestion and nasal itching) at 2 weeks of treatment (or at discontinuation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at each visit prior to initiation of treatment, at Week 1, and Week 2(discontinuation)
    E.5.2Secondary end point(s)
    (1) the change from baseline in the total score of 4 nasal symptoms at 1 week of treatment
    (2) the changes from baseline in individual nasal symptom scores at 1 and 2 weeks of treatment (or at discontinuation)
    (3) Individual nasal finding scores (swelling of inferior nasal concha mucosa, coloring of inferior nasal concha mucosa and rhinorrhea discharged)
    Endpoint: the changes from baseline in individual nasal finding scores at 1 and 2 weeks of treatment (or at discontinuation)
    (4) Score for interference with daily activities
    Endpoint: the changes from baseline in the score for interference with daily activities at 1 and 2 weeks of treatment (or at discontinuation)
    (5) Improvement rate of global response
    Endpoint: the improvement rate of global response (moderate and remarkable improvement) at 1 and 2 weeks of treatment (or at discontinuation)
    (6) Assessment of interaction effects of age strata (5 to 11 years and 12 to 15 years of age) and treatment groups on the primary endpoint results
    An interaction effect was assessed by adding the interaction term of age stratum and treatment group to the analysis of covariance (ANCOVA) model for the primary efficacy endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each visit prior to initiation of treatment, at Week 1, and Week 2(discontinuation)
    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 No
    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 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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    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 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.1.1Number of subjects for this age range: 333
    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: 220
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 113
    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 333
    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)
    Any future care will be provided according to the subject's personal physician
    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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