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    Summary
    EudraCT Number:2014-004916-12
    Sponsor's Protocol Code Number:P05106
    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 number2014-004916-12
    A.3Full title of the trial
    Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Protocol No. P05106).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106).
    A.3.2Name or abbreviated title of the trial where available
    Placebo-Controlled Study MFNS 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis
    A.4.1Sponsor's protocol code numberP05106
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00468312
    A.5.4Other Identifiers
    Name:MK-0887Number:135
    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 Research Institute, a Division of Schering Corporation
    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 supportSchering-Plough Research Institute, a Division of Schering Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough Research Institute, a Division of Schering Corporation
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street Address2015 Galloping Hill Road
    B.5.3.2Town/ cityKenilworth
    B.5.3.3Post code07033
    B.5.3.4CountryUnited States
    B.5.4Telephone number9087405799
    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
    Seasonal Allergic Rhinitis
    E.1.1.1Medical condition in easily understood language
    Seasonal 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
    The primary objective of this study was to assess the efficacy of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score (TNSS) and the total ocular symptom score (TOSS).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study were to assess the efficacy of MFNS in improving nasal congestion, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score, and AM peak nasal inspiratory flow (PNIF).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A subject must have been 12 years of age or older, of either sex, and of any race.
    2. A subject must have had at least a 2-year documented history of SAR which exacerbated during the study season.
    3. A subject must have had a positive skin prick test response to an appropriate seasonal allergen at the Screening Visit. IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees
    and/or grasses) must have been documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
    4. A subject must have been clinically symptomatic at the Screening Visit (assessed by the subject): nasal rhinorrhea must have been ≥2, nasal congestion must have been ≥2, TNSS must have been ≥6, TOSS must have been ≥4, and an overall evaluation of SAR must have been ≥2.
    5. A subject must have been clinically symptomatic at the Baseline Visit. The total of the seven run-in diary reflective (PRIOR) scores for the 3 days prior to Baseline and the AM of the Baseline Visit must have been: rhinorrhea score ≥14, nasal congestion score ≥14, TNSS ≥42, and TOSS ≥28.
    6. A subject must have been in general good health as confirmed by routine clinical and laboratory testing. All laboratory tests must have been within normal limits or clinically acceptable to the investigator and sponsor
    7. A subject must have been free of any clinically significant disease, other than SAR, which would have interfered with the study evaluations.
    8. A subject and/or parent/guardian must have been willing to give written informed consent and must have been able to adhere to dosing and visit schedules and met study requirements.
    9. A female subject of childbearing potential must have had a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must have been using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.
    E.4Principal exclusion criteria
    1. A subject whose ability to provide informed consent was compromised.
    2. A subject with a history of noncompliance with medications or treatment protocols.
    3. A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
    4. A subject with significant medical condition(s) that, in the judgment of the investigator, might have interferedwith the study or required treatment.
    5. A subject who had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who had a viral upper respiratory infection within
    7 days prior to the Screening Visit.
    6. A subject who had used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
    7. Pregnant or nursing females.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy endpoints were the change from Baseline in average AM instantaneous (NOW) TNSS and TOSS over Days 2 to 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study, the severity of symptoms of allergic rhinitis was individually scored twice daily by the subject and was to be based on the subject’s status over the previous 12 hours (reflective or PRIOR) and on the subject’s status at the time of evaluation (instantaneous or NOW).
    E.5.2Secondary end point(s)
    • The change from Baseline in AM NOW nasal congestion score averaged over Days 2 to 15.
    • The change from Baseline in RQLQ total score at Endpoint.
    • The change from Baseline in AM peak nasal inspiratory flow (PNIF) averaged over Days 2 to 15.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study, the severity of symptoms of allergic rhinitis was individually scored twice daily by the subject and was to be based on the subject’s status over the previous 12 hours (reflective or PRIOR) and on the subject’s status at the time of evaluation (instantaneous or NOW).
    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 Yes
    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
    United States
    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 months1
    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: 56
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 56
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 365
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    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 500
    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: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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