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    Clinical Trial Results:
    Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Externa

    Summary
    EudraCT number
    2018-000615-25
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    05 Jan 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Aug 2018
    First version publication date
    05 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-07-13
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00750633
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Alcon Research Ltd
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, TX, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733385, Linda.masson@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733385, Linda.masson@novartis.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
    05 Jan 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jan 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of topical Moxidex for the treatment of acute otitis externa (AOE).
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 990
    Worldwide total number of subjects
    990
    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)
    11
    Children (2-11 years)
    381
    Adolescents (12-17 years)
    189
    Adults (18-64 years)
    379
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited from 76 study centers located in the United States.

    Pre-assignment
    Screening details
    This reporting group includes all randomized and treated subjects (Intent to Treat (ITT) Analysis Set).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    The Investigator, study site personnel, sponsor, and the subject (or parent/guardian) were masked from the identity of each subject’s randomized test article.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Moxidex
    Arm description
    Moxidex solution, 4 drops in the infected ear(s) BID for 7 days
    Arm type
    Experimental

    Investigational medicinal product name
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% solution
    Investigational medicinal product code
    Other name
    Moxidex
    Pharmaceutical forms
    Ear drops
    Routes of administration
    Auricular use
    Dosage and administration details
    4 drops in the infected ear(s) twice daily (BID) for 7 days

    Arm title
    Moxifloxacin
    Arm description
    Moxifloxacin solution, 4 drops in the infected ear(s) BID for 7 days
    Arm type
    Active comparator

    Investigational medicinal product name
    Moxifloxacin 0.5% solution
    Investigational medicinal product code
    Other name
    Moxifloxacin
    Pharmaceutical forms
    Ear drops
    Routes of administration
    Auricular use
    Dosage and administration details
    4 drops in the infected ear(s) BID for 7 days

    Arm title
    Dexamethasone
    Arm description
    Dexamethasone solution, 4 drops in the infected ear(s) BID for 7 days
    Arm type
    Active comparator

    Investigational medicinal product name
    Dexamethasone phosphate 0.1% solution
    Investigational medicinal product code
    Other name
    Dexamethasone
    Pharmaceutical forms
    Ear drops
    Routes of administration
    Auricular use
    Dosage and administration details
    4 drops in the infected ear(s) BID for 7 days

    Number of subjects in period 1
    Moxidex Moxifloxacin Dexamethasone
    Started
    330
    333
    327
    Completed
    292
    284
    241
    Not completed
    38
    49
    86
         Treatment failure
    19
    30
    48
         Baseline culture positive-Group A Strep
    2
    -
    2
         Adverse event, non-fatal
    10
    11
    21
         Inclusion/exclusion violation
    -
    -
    2
         Baseline culture results positive - yeast
    -
    -
    4
         Subject decision unrelated to an AE
    2
    4
    4
         Lost to follow-up
    2
    2
    2
         Other - Reason not given
    3
    2
    2
         Noncompliance
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex
    Reporting group description
    Moxidex solution, 4 drops in the infected ear(s) BID for 7 days

    Reporting group title
    Moxifloxacin
    Reporting group description
    Moxifloxacin solution, 4 drops in the infected ear(s) BID for 7 days

    Reporting group title
    Dexamethasone
    Reporting group description
    Dexamethasone solution, 4 drops in the infected ear(s) BID for 7 days

    Reporting group values
    Moxidex Moxifloxacin Dexamethasone Total
    Number of subjects
    330 333 327 990
    Age categorical
    ITT Analysis Set
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    2 5 4 11
        Children (2-11 years)
    130 128 123 381
        Adolescents (12-17 years)
    63 67 59 189
        Adults (18-64 years)
    125 121 133 379
        From 65-84 years
    10 12 8 30
    Gender categorical
    ITT Analysis Set
    Units: Subjects
        Female
    173 185 177 535
        Male
    157 148 150 455

    End points

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    End points reporting groups
    Reporting group title
    Moxidex
    Reporting group description
    Moxidex solution, 4 drops in the infected ear(s) BID for 7 days

    Reporting group title
    Moxifloxacin
    Reporting group description
    Moxifloxacin solution, 4 drops in the infected ear(s) BID for 7 days

    Reporting group title
    Dexamethasone
    Reporting group description
    Dexamethasone solution, 4 drops in the infected ear(s) BID for 7 days

    Primary: Percentage of subjects with Clinical Cure - Moxidex vs Moxifloxacin

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    End point title
    Percentage of subjects with Clinical Cure - Moxidex vs Moxifloxacin [1]
    End point description
    Clinical cure was attained if the sum of the 3 signs and symptoms of acute otitis externa (AOE) (erythema, edema and tenderness) was zero (i.e. none) and remained zero for the remainder of the study. Pre-specified for Moxidex and Moxifloxacin. This analysis population includes all subjects who received drug and were culture positive for bacteria on Day 1 (Modified intent-to-treat (MITT) Analysis Set).
    End point type
    Primary
    End point timeframe
    Day 3
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was pre-specified for Moxidex and Moxifloxacin only.
    End point values
    Moxidex Moxifloxacin
    Number of subjects analysed
    330
    333
    Units: percentage of subjects
        number (not applicable)
    13.0
    15.5
    Statistical analysis title
    Clinical Cure
    Comparison groups
    Moxidex v Moxifloxacin
    Number of subjects included in analysis
    663
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.382 [2]
    Method
    Chi-squared
    Confidence interval
    Notes
    [2] - Demonstration of efficacy (p<0.05) is required for both primary end point comparisons to control family wise error (FWE) rate at α=0.05. If only one end point is significant at p<0.05, the primary objective is not met.

    Primary: Percentage of subjects with Clinical Cure - Moxidex vs Dexamethasone

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    End point title
    Percentage of subjects with Clinical Cure - Moxidex vs Dexamethasone [3]
    End point description
    Clinical cure was attained if the sum of the 3 signs and symptoms of acute otitis externa (AOE) (erythema, edema and tenderness) was zero (i.e. none) and remained zero for the remainder of the study. Prespecified for Moxidex and Dexamethasone. MITT Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was pre-specified for Moxidex and Dexamethasone only.
    End point values
    Moxidex Dexamethasone
    Number of subjects analysed
    301
    295
    Units: percentage of subjects
        number (not applicable)
    79.4
    57.6
    Statistical analysis title
    Clinical Cure
    Comparison groups
    Moxidex v Dexamethasone
    Number of subjects included in analysis
    596
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [4]
    Method
    Chi-squared
    Confidence interval
    Notes
    [4] - Demonstration of efficacy (p<0.05) is required for both primary end point comparisons to control family wise error (FWE) rate at α=0.05. If only one end point is significant at p<0.05, the primary objective is not met.

    Secondary: Percentage of subjects with Microbiological Success

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    End point title
    Percentage of subjects with Microbiological Success [5]
    End point description
    Microbiological success was defined as the eradication of pre-therapy pathogens at subsequent visits. This end point was pre-specified for Moxidex and Dexamethasone. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 12
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was pre-specified for Moxidex and Dexamethasone only.
    End point values
    Moxidex Dexamethasone
    Number of subjects analysed
    301
    295
    Units: percentage of subjects
    number (not applicable)
        Day 8
    74.4
    26.4
        Day 12
    79.1
    40.0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Clinical Cure - Moxidex vs Moxifloxacin

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    End point title
    Percentage of subjects with Clinical Cure - Moxidex vs Moxifloxacin [6]
    End point description
    Clinical cure was attained if the sum of the 3 signs and symptoms of AOE (erythema, edema and tenderness) was zero (i.e. none) and remained zero for remainder of the study. Pre-specified for Moxidex and Moxifloxacin. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 12
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was pre-specified for Moxidex and Moxifloxacin only.
    End point values
    Moxidex Moxifloxacin
    Number of subjects analysed
    301
    291
    Units: percentage of subjects
    number (not applicable)
        Day 8
    63.1
    56.0
        Day 12
    79.4
    73.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Clinical Cure - Moxidex vs Dexamethasone

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    End point title
    Percentage of subjects with Clinical Cure - Moxidex vs Dexamethasone [7]
    End point description
    Clinical cure was attained if the sum of the 3 signs and symptoms of AOE (erythema, edema and tenderness) was zero (i.e. none) and remained zero for remainder of the study. Pre-specified for Moxidex and Dexamethasone. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 3, Day 8
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was pre-specified for Moxidex and Dexamethasone only.
    End point values
    Moxidex Dexamethasone
    Number of subjects analysed
    301
    295
    Units: percentage of subjects
    number (not applicable)
        Day 3
    13.0
    11.2
        Day 8
    63.1
    41.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment Failure

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    End point title
    Percentage of Subjects with Treatment Failure
    End point description
    Treatment failure was defined as a subject who discontinued the study due to treatment failure prior to or at the Day 3 or Day 8 visit, or were not considered to be a clinical cure at the Day 12 visit. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 3, Day 8, Day 12
    End point values
    Moxidex Moxifloxacin Dexamethasone
    Number of subjects analysed
    301
    291
    295
    Units: percentage of subjects
    number (not applicable)
        Day 3
    5.6
    9.6
    15.9
        Day 8
    5.6
    9.6
    15.9
        Day 12
    20.6
    26.1
    42.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    This analysis population includes all subjects who received drug (Safety Analysis Set).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Moxidex - Otic
    Reporting group description
    Subjects treated with Moxidex solution

    Reporting group title
    Moxifloxacin - Otic
    Reporting group description
    Subjects treated with Moxifloxacin solution

    Reporting group title
    Dexamethasone - Otic
    Reporting group description
    Subjects treated with Dexamethasone solution

    Reporting group title
    Moxidex - Non-Otic
    Reporting group description
    Subjects treated with Moxidex solution

    Reporting group title
    Moxifloxacin - Non-Otic
    Reporting group description
    Subjects treated with Moxifloxacin solution

    Reporting group title
    Dexamethasone - Non-Otic
    Reporting group description
    Subjects treated with Dexamethasone solution

    Serious adverse events
    Moxidex - Otic Moxifloxacin - Otic Dexamethasone - Otic Moxidex - Non-Otic Moxifloxacin - Non-Otic Dexamethasone - Non-Otic
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Anaesthetic complication
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Moxidex - Otic Moxifloxacin - Otic Dexamethasone - Otic Moxidex - Non-Otic Moxifloxacin - Non-Otic Dexamethasone - Non-Otic
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 330 (4.55%)
    19 / 333 (5.71%)
    30 / 327 (9.17%)
    35 / 330 (10.61%)
    27 / 333 (8.11%)
    28 / 327 (8.56%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Surgical and medical procedures
    Acrochordon excision
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    2 / 330 (0.61%)
    0 / 333 (0.00%)
    3 / 327 (0.92%)
         occurrences all number
    0
    0
    0
    2
    0
    3
    Fatigue
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    2 / 333 (0.60%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    1 / 333 (0.30%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    Cough
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Foreign body
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Arthropod sting
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Procedural complication
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Injury
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    2 / 333 (0.60%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    9 / 330 (2.73%)
    7 / 333 (2.10%)
    6 / 327 (1.83%)
         occurrences all number
    0
    0
    0
    9
    7
    7
    Dizziness
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    3 / 330 (0.91%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Epilepsy
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    1 / 330 (0.30%)
    2 / 333 (0.60%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 330 (0.30%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    5 / 327 (1.53%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    5
    0
    0
    0
    Ear discomfort
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Ear haemorrhage
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Excessive cerumen production
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    3 / 330 (0.91%)
    2 / 333 (0.60%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    3
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Otitis media
         subjects affected / exposed
    4 / 330 (1.21%)
    8 / 333 (2.40%)
    9 / 327 (2.75%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    4
    8
    9
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    2 / 330 (0.61%)
    6 / 333 (1.80%)
    9 / 327 (2.75%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    2
    6
    9
    0
    0
    0
    Mastoiditis
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Otitis externa fungal
         subjects affected / exposed
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    3 / 330 (0.91%)
    7 / 333 (2.10%)
    3 / 327 (0.92%)
         occurrences all number
    0
    0
    0
    3
    7
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    3 / 330 (0.91%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    2 / 330 (0.61%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Bronchitis viral
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    1 / 330 (0.30%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    4 / 327 (1.22%)
         occurrences all number
    0
    0
    0
    0
    1
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    1 / 333 (0.30%)
    0 / 327 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Impetigo
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Localised infection
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Varicella
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    0 / 327 (0.00%)
    0 / 330 (0.00%)
    0 / 333 (0.00%)
    1 / 327 (0.31%)
         occurrences all number
    0
    0
    0
    0
    0
    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? No

    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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    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.

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