Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)

    Summary
    EudraCT number
    		 2014-004920-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Oct 2008

    Results information
    Results version number
    		 v3(current)
    This version publication date
    14 Sep 2016
    First version publication date
    19 Jul 2015
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    P05583
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00728416
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number:: MK-0887-160
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, NJ, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Oct 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the efficacy in relieving the symptom of nasal congestion with MFNS 200 mcg given once daily compared to placebo in subjects with symptomatic SAR.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jul 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 333
    Worldwide total number of subjects
    333
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    28
    Adults (18-64 years)
    294
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants 12 years of age or older with symptomatic SAR were recruited. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 Participants were screened for study inclusion over Day -14 to Day -3.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone furoate nasal spray
    Arm description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    mometasone furoate
    Investigational medicinal product code
    Other name
    MK-0887, Nasonex Nasal Spray
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

    Arm title
    		 Placebo Nasal Spray
    Arm description
    		 Matching placebo nasal spray
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

    Number of subjects in period 1
    		Mometasone furoate nasal spray Placebo Nasal Spray
    Started
    168
    165
    Completed
    166
    163
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    1
         Treatment Failure
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)

    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 Matching placebo nasal spray

    Reporting group values
    		 Mometasone furoate nasal spray Placebo Nasal Spray Total
    Number of subjects
    		 168 165 333
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 14 14 28
        Adults (18-64 years)
    		 148 146 294
        From 65-84 years
    		 6 5 11
    Gender Categorical
    Units: Subjects
        Female
    		 109 103 212
        Male
    		 59 62 121

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 Mometasone furoate nasal spray 200 mcg QD (once per day)

    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 Matching placebo nasal spray

    Primary: The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days

    		 Close Top of page
    End point title
    		 The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days
    End point description
    Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
    End point type
    Primary
    End point timeframe
    15 days of treatment
    End point values
    		 Mometasone furoate nasal spray Placebo Nasal Spray
    Number of subjects analysed
    168
    164 [1]
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.71 (-0.81 to -0.61)
    -0.4 (-0.5 to -0.3)
    Notes
    [1] - 1 participant without baseline value excluded.
    Statistical analysis title
    		 Comparison of Treatment Groups
    Statistical analysis description
    The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.
    Comparison groups
    Mometasone furoate nasal spray v Placebo Nasal Spray
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 -0.19

    Secondary: The change from Baseline in average AM/PM PRIOR total nasal symptom score (TNSS) over 15 days

    		 Close Top of page
    End point title
    		 The change from Baseline in average AM/PM PRIOR total nasal symptom score (TNSS) over 15 days
    End point description
    Total nasal symptom score is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
    End point type
    Secondary
    End point timeframe
    15 days of treatment
    End point values
    		 Mometasone furoate nasal spray Placebo Nasal Spray
    Number of subjects analysed
    168
    164 [2]
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -3 (-3.38 to -2.62)
    -1.73 (-2.11 to -1.34)
    Notes
    [2] - 1 participant without baseline value excluded.
    Statistical analysis title
    		 Comparison of Treatment Groups
    Statistical analysis description
    The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.
    Comparison groups
    Mometasone furoate nasal spray v Placebo Nasal Spray
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.72
         upper limit
    		 -0.83

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 up to 30 days after study completion/discontinuation (up to 45 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 -

    Reporting group title
    Mometasone furoate nasal spray
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Nasal Spray Mometasone furoate nasal spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 168 (0.00%)
    0 / 168 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Nasal Spray Mometasone furoate nasal spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 168 (0.00%)
    0 / 168 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events met the incidence threshold for reporting.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 15:57:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA