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    Summary
    EudraCT Number:2014-004917-10
    Sponsor's Protocol Code Number:P05155
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-03
    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 number2014-004917-10
    A.3Full title of the trial
    A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Multicenter Clinical Trial To Evaluate Efficacy And Safety Of Mometasone Furoate Nasal Spray In Children With Adenoid Hypertrophy. SNORE Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy.
    A.4.1Sponsor's protocol code numberP05155
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00552032
    A.5.4Other Identifiers
    Name:-Number:MK-0887-138
    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 SponsorSchering-Plough S.A. de C.V.
    B.1.3.4CountryMexico
    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 S.A. de C.V.
    B.4.2CountryMexico
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough S.A. de C.V.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressAv. 16 De Septiembre No. 301
    B.5.3.2Town/ cityMexico City, Distrito Federal
    B.5.3.3Post code16090
    B.5.3.4CountryMexico
    B.5.4Telephone number+12673055921
    B.5.6E-mailgeorge_philip@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 Yes
    D.2.1.1.1Trade name NASONEX®
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNasonex®
    D.3.2Product code SCH 32088 (MK 0887)
    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.3.9.3Other descriptive nameMOMETASONE FUROATE
    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
    Adenoid Hypertrophy.
    E.1.1.1Medical condition in easily understood language
    Adenoid Hypertrophy.
    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
    The study objectives were to assess the efficacy and safety of 8-week treatment with Mometasone Furoate nasal spray (MFNS) 100 μg twice daily (b.i.d) (1 puff of 50 μg in each nasal fossa) in children aged 2 to 11 years with adenoid hypertrophy (AH) with or without otitis media effusion (OME).
    E.2.2Secondary objectives of the trial
    Secondary objectives were improvement in Total and Individual Severity Symptoms Score and Frequency Symptoms Score graded by the parents during the study, physical examination, bilateral tympanogram, Quality of Sleep and Quality of Life, rhinomanometry, pure tone audiometry and acoustic rhinometry in children from 7 to 11 years old.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects and their parents must have demonstrated their willingness to participate in the study and comply with these procedures. Parents must have signed a written informed consent.
    •Children 2 to 11 years old of any gender and ethnic background.
    •Subjects and subject’s parents who must have understood and would be able to adhere to dosing and visit schedules, and agree to record symptom severity scale scores, medication times and concomitant medications accurately and consistently in a diary.
    •Children with a history of AH for at least 3 months with no response to previous medical treatment.
    •Size of adenoid tissue must have been graded by nasopharyngoscopic examination as Grade III or IV on the A/C Index at baseline (between 50% and 100% obstruction).
    •Baseline total symptom severity score must have been at least 8 points AM (morning) or PM (evening).
    •OME criteria for the study were as follows: (1) persistent middle ear effusion documented by otoscopic examination for the past 3 months at study entry, (2) middle ear pressure less than - 10 mm H2O, (3) Jerger type B flat tympanogram and/or (4) mild-to-moderate conductive hearing loss in audiometry supporting the diagnosis of OME. Each ear must have been evaluated separately during the study.
    •Subjects’ parents must have understood and would be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
    E.4Principal exclusion criteria
    •Subjects with previous surgery of AH with or without tympanostomy tube placement.
    •Subjects previously treated with inhaled or systemic corticosteroids within the past 1 month.
    •Subjects with Morbid Obesity (Body Mass Index [BMI] >95 percentile of charts from the Center for Disease Control [CDC]).
    •Subjects who had not accomplished the designated washout period for any of the prohibited medications and subjects who had used any investigational products within the last 30 days or any antibodies for allergies within 90 days of study enrollment.
    •Subjects who had any clinically significant abnormal physical examination result which, in the investigator’s judgment, which may have interfered with study evaluations or affect subject safety.
    •Subjects who were allergic or who had an idiosyncratic reaction to
    corticosteroids.
    •Subjects with signs and symptoms of acute or chronic bacterial rhinosinusitis. Subjects who have had an upper or lower respiratory tract or paranasal sinus infection which required antibiotic therapy with the last dose not later than 14 days prior to recruitment, or who have had a viral upper or lower respiratory
    tract infection within 7 days prior to recruitment.
    •Subjects with a documented immunodeficiency condition.
    •Subjects with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow.
    •Subjects with any clinically significant metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which, in the investigator’s judgment, may have interfered with study evaluations or affect subject safety.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint was the reduction in adenoid size as compared to baseline and throughout the study evaluated by nasopharyngoscopy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 and 6
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints were:
    •Improvement in total severity symptom sore (morning [AM] and evening [PM]
    scores including scores for snoring, nasal obstruction, oral breathing, ear pain, nasal discharge and breathing difficulty).
    •Improvement in measures of bilateral tympanogram from baseline to assessment and 16-week follow-up period in all subjects.
    •Improvement in rhinomanometry, acoustic rhinometry and pure-tone audiometry measures from baseline to throughout the course of the study in children aged 7 to 11 years from baseline to the 16-week follow-up period.
    •Improvement in otoscopic and rhinoscopic examination.
    •Double-blind follow-up period to complete 6 months (24 weeks) via nasopharyngoscopic evaluation every 2 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Vist 2 and Visit 6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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
    Mexico
    Peru
    Venezuela, Bolivarian Republic of
    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 months6
    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: 132
    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: 132
    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
    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 144
    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)
    The subject will revert to usual care according to his/her own 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: Mexico
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