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    Clinical Trial Results:
    Randomised, double-blind, double-dummy, vehicle controlled parallel trial comparing a novel mometasone furoate nasal spray vs. Nasonex® nasal spray vs. vehicle nasal spray in patients with allergic rhinitis

    Summary
    EudraCT number
    2013-000654-22
    Trial protocol
    DE  
    Global end of trial date
    26 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Jul 2016
    First version publication date
    21 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13-01/MOM-N
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover-Ring 7, Gruenwald, Germany, 82031
    Public contact
    Head of Clinical Department, Clinical Department, 0049 08964186-0,
    Scientific contact
    Head of Clinical Department, Clinical Department, 0049 08964186-0,
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy and safety of a new nasal spray with the active ingredient mometasone furoate vs. the originator Nasonex® vs. vehicle in patients with allergic rhinitis.
    Protection of trial subjects
    There were no specific measures necessary.
    Background therapy
    There was no background therapy.
    Evidence for comparator
    The trial aimed to show non-inferiority with regard to the comparator in order to obtain a generic marketing authorization for the test product.
    Actual start date of recruitment
    20 Aug 2013
    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
    Germany: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    0
    Adults (18-64 years)
    93
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    all study centers in Germany; first patient first visit: 16. September 2013; last patient last visit: 26. February 2015

    Pre-assignment
    Screening details
    Main inclusion criteria: Women or men ≥ 18 years of age; Diagnosis of persistent allergic rhinitis: symptoms present for more than 4 consecutive weeks; the patient is clinically symptomatic with the following baseline symptom scores after 1 week of screening: iTNSS ≥ 6, with nasal congestion score ≥ 2, and rhinorrhea, nasal itching or sneezing ≥ 2

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The devices for administration of test and reference are visually different. Therefore a double-dummy study design was chosen to facilitate double-blind application of the study drugs. Each patient received two devices with stochastical assignment of the active ingredient preparation to one of the devices. He/she had to apply the study medication from both devices in a pre-specified sequence throughout the course of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Mometasone nasal spray
    Arm description
    Treatment arm with active ingredient in the test device
    Arm type
    Experimental

    Investigational medicinal product name
    Mometasone furoate nasal spray
    Investigational medicinal product code
    R01AD09
    Other name
    Pharmaceutical forms
    Nasal spray, emulsion
    Routes of administration
    Intranasal use
    Dosage and administration details
    One actuation of nasal spray per nostril twice daily was applied (50 µg mometasone furoate per actuation). The resulting total daily dose was 200 µg mometasone furoate.

    Arm title
    Nasonex
    Arm description
    Treatment arm with active ingredient in the reference device
    Arm type
    Active comparator

    Investigational medicinal product name
    Nasonex
    Investigational medicinal product code
    R01AD09
    Other name
    Pharmaceutical forms
    Nasal spray, emulsion
    Routes of administration
    Intranasal use
    Dosage and administration details
    One actuation of nasal spray per nostril twice daily was applied (50 µg mometasone furoate per actuation). The resulting total daily dose was 200 µg,

    Arm title
    Placebo
    Arm description
    Treatment arm without active ingredient in both devices
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, emulsion
    Routes of administration
    Intranasal use
    Dosage and administration details
    One actuation of nasal spray per nostril, twice daily

    Number of subjects in period 1
    Mometasone nasal spray Nasonex Placebo
    Started
    43
    36
    22
    Completed
    39
    34
    19
    Not completed
    4
    2
    3
         Protocol deviation
    1
    -
    -
         Patient's request because of healing
    2
    -
    1
         Lack of efficacy
    -
    -
    1
         Adverse event, non-fatal
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    -

    Reporting group values
    Treatment period Total
    Number of subjects
    101 101
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    93 93
        From 65-84 years
    8 8
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    66 66
        Male
    35 35
    Subject analysis sets

    Subject analysis set title
    Safety data set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once and provide any follow-up data

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data set who comply with the study diagnosis (according to the associated inclusion criteria) and provide the baseline value and at least one post baseline value of the TNSS (either iTNSS or rTNSS)

    Subject analysis sets values
    Safety data set Full Analysis Set
    Number of subjects
    101
    101
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    93
    93
        From 65-84 years
    8
    8
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    66
    66
        Male
    35
    35

    End points

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    End points reporting groups
    Reporting group title
    Mometasone nasal spray
    Reporting group description
    Treatment arm with active ingredient in the test device

    Reporting group title
    Nasonex
    Reporting group description
    Treatment arm with active ingredient in the reference device

    Reporting group title
    Placebo
    Reporting group description
    Treatment arm without active ingredient in both devices

    Subject analysis set title
    Safety data set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once and provide any follow-up data

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data set who comply with the study diagnosis (according to the associated inclusion criteria) and provide the baseline value and at least one post baseline value of the TNSS (either iTNSS or rTNSS)

    Primary: Treatment effect

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    End point title
    Treatment effect [1]
    End point description
    change of DrTNSS between start and end of treatment; calculated as the mean of the morning assessments (AMrTNSS) and the evening assessments (PMrTNSS) of the Reflective Total Nasal Symptom Score (rTNSS) in the patient diaries
    End point type
    Primary
    End point timeframe
    Between Start and End of Treatment.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to the substantial reduction in sample size there was not enough power to investigate the primary objectives of the study (statistical equivalence of the active treatments and superiority of both preparations over placebo) in a reliable way. The primary efficacy parameter is therefore only displayed in a descriptive way.
    End point values
    Mometasone nasal spray Nasonex Placebo Full Analysis Set
    Number of subjects analysed
    43
    36
    22
    101
    Units: score units
        median (full range (min-max))
    -6.5 (-11.5 to 3.5)
    -5.8 (-10.5 to 1)
    -6.5 (-9 to -1)
    -6.5 (-11.5 to 3.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Inclusion visit (= start of screening) to End of treatment (Main visit)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Mometasone nasal spray
    Reporting group description
    Treatment arm with active ingredient preparation in test device

    Reporting group title
    Nasonex
    Reporting group description
    Treatment arm with active ingredient in the reference device

    Reporting group title
    Placebo
    Reporting group description
    Treatment arm without active ingredient in both devices

    Serious adverse events
    Mometasone nasal spray Nasonex Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    Mometasone nasal spray Nasonex Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 43 (30.23%)
    17 / 36 (47.22%)
    11 / 22 (50.00%)
    General disorders and administration site conditions
    Mucosal dryness
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Post-traumatic pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Stab wound
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood cortisol increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic pharyngitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Asthma
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 36 (8.33%)
    1 / 22 (4.55%)
         occurrences all number
    1
    5
    1
    Nasal discomfort
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal dryness
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 36 (2.78%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis atrophic
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Sneezing
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 36 (5.56%)
    4 / 22 (18.18%)
         occurrences all number
    1
    2
    5
    Eye disorders
    Eczema eyelids
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Eye allergy
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Back pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Zinc deficiency
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Infectious mononucleosis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 43 (6.98%)
    4 / 36 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    3
    4
    1
    Oral herpes
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 36 (2.78%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 36 (2.78%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Feb 2015
    The trial was prematurely ended due to a low recruitment rate. There were no safety concerns.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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