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    Clinical Trial Results:
    Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes

    Summary
    EudraCT number
    2018-000643-37
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    14 Oct 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C-09-033
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01071902
    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
    14 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2011
    Was the trial ended prematurely?
    Yes
    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 subjects with acute otitis media with tympanostomy tubes (AOMT).
    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
    06 Apr 2010
    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: 345
    Country: Number of subjects enrolled
    Canada: 55
    Worldwide total number of subjects
    400
    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)
    177
    Children (2-11 years)
    220
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited from 45 sites located in Canada (5) and the United States (40).

    Pre-assignment
    Screening details
    This reporting group includes all randomized subjects (400).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Moxidex Solution
    Arm description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days
    Arm type
    Experimental

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

    Arm title
    Moxifloxacin Solution
    Arm description
    Moxifloxacin hydrochloride 0.5% otic solution, 4 drops BID for 7 days
    Arm type
    Active comparator

    Investigational medicinal product name
    Moxifloxacin hydrochloride 0.5% otic solution
    Investigational medicinal product code
    Other name
    Moxifloxacin
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Auricular use
    Dosage and administration details
    4 drops BID for 7 days

    Arm title
    Vehicle
    Arm description
    Moxifloxacin/dexamethasone phosphate otic solution vehicle, 4 drops BID for 7 days
    Arm type
    Placebo

    Investigational medicinal product name
    Moxifloxacin/dexamethasone phosphate otic solution vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Auricular use
    Dosage and administration details
    4 drops BID for 7 days

    Number of subjects in period 1
    Moxidex Solution Moxifloxacin Solution Vehicle
    Started
    134
    138
    128
    Completed
    100
    83
    37
    Not completed
    34
    55
    91
         Treatment failure
    18
    31
    61
         Baseline culture results positive for Strep A
    2
    4
    2
         Adverse event, non-fatal
    10
    16
    17
         Inclusion/exclusion violation
    1
    -
    1
         Baseline culture results positive for yeast
    -
    2
    2
         Lost to follow-up
    1
    -
    -
         Other - Reason not given
    2
    2
    7
         Noncompliance
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex Solution
    Reporting group description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    Moxifloxacin hydrochloride 0.5% otic solution, 4 drops BID for 7 days

    Reporting group title
    Vehicle
    Reporting group description
    Moxifloxacin/dexamethasone phosphate otic solution vehicle, 4 drops BID for 7 days

    Reporting group values
    Moxidex Solution Moxifloxacin Solution Vehicle Total
    Number of subjects
    134 138 128 400
    Age categorical
    This analysis population includes all subjects who received study drug (Intent-to-Treat (ITT) Analysis Set)
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    62 62 53 177
        Children (2-11 years)
    72 75 73 220
        Adolescents (12-17 years)
    0 1 2 3
    Gender categorical
    ITT Analysis Set
    Units: Subjects
        Female
    54 65 52 171
        Male
    80 73 76 229

    End points

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    End points reporting groups
    Reporting group title
    Moxidex Solution
    Reporting group description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    Moxifloxacin hydrochloride 0.5% otic solution, 4 drops BID for 7 days

    Reporting group title
    Vehicle
    Reporting group description
    Moxifloxacin/dexamethasone phosphate otic solution vehicle, 4 drops BID for 7 days

    Primary: Clinical cure rate at Day 8

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    End point title
    Clinical cure rate at Day 8 [1]
    End point description
    Clinical cure was attained if the clinical response was resolved/cured (ie, absence of otorrhea) as evaluated by the Investigator at the end-of-therapy (EOT) visit. Reported as a percentage of subjects. This analysis population includes all subjects in the ITT population who were culture positive on Day 1 (Modified Intent-to-Treat (MITT) Analysis Set). Due to the study being cancelled, no statistical testing was performed.
    End point type
    Primary
    End point timeframe
    Day 8
    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: No statistical testing was performed due to early termination of the study.
    End point values
    Moxidex Solution Moxifloxacin Solution Vehicle
    Number of subjects analysed
    96
    91
    98
    Units: percentage of subjects
        number (not applicable)
    68.8
    60.4
    16.3
    No statistical analyses for this end point

    Secondary: Time to Cessation of Otorrhea

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    End point title
    Time to Cessation of Otorrhea
    End point description
    Time to cessation of otorrhea was defined as the time (in days) to the absence of otorrhea (i.e. otorrhea was absent and remained absent) and was calculated as the number of days from first dose of study treatment to the absence of otorrhea as recorded by parent/guardian via the patient diary. MITT with non-missing data. Due to the study being cancelled, no statistical testing was performed.
    End point type
    Secondary
    End point timeframe
    Up to Day 8
    End point values
    Moxidex Solution Moxifloxacin Solution Vehicle
    Number of subjects analysed
    96
    91
    97
    Units: days
        median (full range (min-max))
    3.00 (0.0 to 18.0)
    4.00 (0.5 to 19.0)
    6.00 (0.5 to 17.0)
    No statistical analyses for this end point

    Secondary: Microbiological success at Day 8 (EOT) by Treatment

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    End point title
    Microbiological success at Day 8 (EOT) by Treatment
    End point description
    Microbiological success was defined as eradication of pre-therapy pathogens at Day 8 (EOT). A subject with no clinical signs of acute otitis media with otorrhea in tympanostomy tubes (AOMT) (i.e. clinical response was resolved/cured) and presumed eradication of pre-therapy pathogens was considered a microbiological success. Reported as a percentage. MITT Analysis Set. Due to the study being cancelled, no statistical testing was performed.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    Moxidex Solution Moxifloxacin Solution Vehicle
    Number of subjects analysed
    96
    91
    98
    Units: percentage of subjects
        number (not applicable)
    67.7
    58.2
    15.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events 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 at least one dose of study 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 Solution
    Reporting group description
    Subjects treated with Moxidex solution

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    Subjects treated with Moxifloxacin solution

    Reporting group title
    Vehicle
    Reporting group description
    Subjects treated with Moxidex vehicle

    Serious adverse events
    Moxidex Solution Moxifloxacin Solution Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    0 / 128 (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%
    Non-serious adverse events
    Moxidex Solution Moxifloxacin Solution Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 134 (32.84%)
    39 / 138 (28.26%)
    41 / 128 (32.03%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    3 / 134 (2.24%)
    1 / 138 (0.72%)
    2 / 128 (1.56%)
         occurrences all number
    3
    1
    2
    Concussion
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital haematoma
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Granuloma
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    5 / 134 (3.73%)
    6 / 138 (4.35%)
    3 / 128 (2.34%)
         occurrences all number
    5
    6
    3
    Malaise
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    4 / 134 (2.99%)
    3 / 138 (2.17%)
    1 / 128 (0.78%)
         occurrences all number
    4
    3
    1
    Ear discomfort
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    2
    0
    1
    Otorrhoea
         subjects affected / exposed
    0 / 134 (0.00%)
    3 / 138 (2.17%)
    2 / 128 (1.56%)
         occurrences all number
    0
    3
    2
    Ear haemorrhage
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoacusis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    5 / 134 (3.73%)
    2 / 138 (1.45%)
    2 / 128 (1.56%)
         occurrences all number
    5
    2
    2
    Diarrhoea
         subjects affected / exposed
    4 / 134 (2.99%)
    1 / 138 (0.72%)
    3 / 128 (2.34%)
         occurrences all number
    4
    1
    3
    Abdominal discomfort
         subjects affected / exposed
    3 / 134 (2.24%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    3
    0
    0
    Constipation
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Teething
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    1
    0
    1
    Oral mucosal eruption
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 134 (2.24%)
    2 / 138 (1.45%)
    2 / 128 (1.56%)
         occurrences all number
    3
    2
    2
    Nasal congestion
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    1
    0
    1
    Rash
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Synovial cyst
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    5 / 134 (3.73%)
    10 / 138 (7.25%)
    9 / 128 (7.03%)
         occurrences all number
    5
    10
    9
    Otitis media acute
         subjects affected / exposed
    3 / 134 (2.24%)
    6 / 138 (4.35%)
    3 / 128 (2.34%)
         occurrences all number
    3
    6
    3
    Ear infection
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    2 / 128 (1.56%)
         occurrences all number
    1
    0
    2
    Otitis externa
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    2 / 128 (1.56%)
         occurrences all number
    1
    0
    2
    External ear cellulitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 134 (2.24%)
    1 / 138 (0.72%)
    3 / 128 (2.34%)
         occurrences all number
    3
    1
    3
    Conjunctivitis
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 138 (0.00%)
    2 / 128 (1.56%)
         occurrences all number
    2
    0
    2
    Croup infectious
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    3 / 128 (2.34%)
         occurrences all number
    1
    0
    3
    Sinusitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 138 (0.00%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 134 (0.00%)
    2 / 138 (1.45%)
    0 / 128 (0.00%)
         occurrences all number
    0
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 134 (0.00%)
    2 / 138 (1.45%)
    0 / 128 (0.00%)
         occurrences all number
    0
    2
    0
    Bronchiolitis
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 138 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 138 (0.72%)
    0 / 128 (0.00%)
         occurrences all number
    0
    1
    0

    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
    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.

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