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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients.

    Summary
    EudraCT number
    		 2010-023239-40
    Trial protocol
    		 ES   SE   FI   DK   CZ  
    Global end of trial date
    29 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    12 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIFLOTIII/10IA04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01404611
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios SALVAT, S.A.
    Sponsor organisation address
    Gall 30-36, Esplugues de Llobregat, Spain, 08950
    Public contact
    Medical Department, Laboratorios SALVAT, S.A., +34 93 394 64 00, clinicaltrials@salvatbiotech.com
    Scientific contact
    Medical Director, Laboratorios SALVAT, S.A., +34 93 394 64 70, ejimenezv@salvatbiotech.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy and safety of topical Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution twice a day for 7 days and the primary endpoint is to demonstrate therapeutic superiority for time to cessation of otorrhea over Ciprofloxacin 0.3% otic solution and over Fluocinolone Acetonide 0.025% otic solution, in patients suffering from AOMT. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absent until the end of the study.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2011
    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
    Spain: 73
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    South Africa: 26
    Country: Number of subjects enrolled
    United States: 229
    Worldwide total number of subjects
    331
    EEA total number of subjects
    74
    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)
    140
    Children (2-11 years)
    187
    Adolescents (12-17 years)
    4
    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
    		 The recruitment period was from August 2011 to May 2013 in Europe (Czech Republic, Denmark, Finland, Spain and Sweden), South Africa, Canada and USA

    Pre-assignment
    Screening details
    		 Patients between 6 months and 12 years with AOMT. Patients had to suffer from otorrhea for 3 weeks or less. Otorrhea had to be moderate or severe and purulent.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The patient was randomized using IWRS. All study medication products (test and comparators) had the same packaging and labels, and the boxes in which the study medication was packaged, shipped, and dispensed were identical in appearance. The central laboratory was blinded to the treatment assignment of the patient from whom the sample was collected.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CIPRO+FLUO
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ciprofloxacin plus Fluocinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution in single-dose container
    Routes of administration
    Auricular use
    Dosage and administration details
    Administer the contents of one 0.25ml single dose vial twice a day to the affected ear(s) for seven days

    Arm title
    		 CIPRO
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution in single-dose container
    Routes of administration
    Auricular use
    Dosage and administration details
    Administer the contents of one 0.25ml single dose vial twice a day to the affected ear(s) for seven days

    Arm title
    		 FLUO
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluocinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution in single-dose container
    Routes of administration
    Auricular use
    Dosage and administration details
    Administer the contents of one 0.25ml single dose vial twice a day to the affected ear(s) for seven days

    Number of subjects in period 1
    		CIPRO+FLUO CIPRO FLUO
    Started
    111
    112
    108
    Completed
    106
    104
    89
    Not completed
    5
    8
    19
         Consent withdrawn by subject
    -
    2
    1
         Physician decision
    -
    -
    1
         Lack of comunication
    1
    -
    -
         Adverse event, non-fatal
    -
    2
    3
         Lost to follow-up
    2
    -
    4
         Protocol deviation
    2
    -
    -
         Lack of efficacy
    -
    4
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CIPRO+FLUO
    Reporting group description
    		 -

    Reporting group title
    CIPRO
    Reporting group description
    		 -

    Reporting group title
    FLUO
    Reporting group description
    		 -

    Reporting group values
    		 CIPRO+FLUO CIPRO FLUO Total
    Number of subjects
    		 111 112 108 331
    Age categorical
    Units: Subjects
        6 months to 12 years
    		 111 112 108 331
    Gender categorical
    Units: Subjects
        Female
    		 46 43 49 138
        Male
    		 65 69 59 193

    End points

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    End points reporting groups
    Reporting group title
    CIPRO+FLUO
    Reporting group description
    		 -

    Reporting group title
    CIPRO
    Reporting group description
    		 -

    Reporting group title
    FLUO
    Reporting group description
    		 -

    Primary: Time to cessation of otorrhea

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    End point title
    		 Time to cessation of otorrhea
    End point description
    End point type
    Primary
    End point timeframe
    During all study (22 days)
    End point values
    		 CIPRO+FLUO CIPRO FLUO
    Number of subjects analysed
    111
    112
    108
    Units: day
        median (confidence interval 95%)
    4.94 (3.74 to 5.52)
    6.83 (5.49 to 7.74)
    22 (13.93 to 22)
    Statistical analysis title
    		 Time to cessation of otorrhea
    Statistical analysis description
    The time to cessation of otorrhea was calculated in days. Survival analysis was done using nonparametric Kaplan-Meier method. Patients who did not discontinue prematurely and for whom the otorrhea still persists at the end of the study (or Day 22 if earlier) are censored at Day 22. Patients who discontinued for any reason or took rescue medication are censored at Day 22.
    Comparison groups
    CIPRO+FLUO v CIPRO v FLUO
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All the study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    CIPRO+FLUO
    Reporting group description
    		 -

    Reporting group title
    CIPRO
    Reporting group description
    		 -

    Reporting group title
    FLUO
    Reporting group description
    		 -

    Serious adverse events
    		 CIPRO+FLUO CIPRO FLUO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 112 (0.00%)
    0 / 107 (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
    		 CIPRO+FLUO CIPRO FLUO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 111 (2.70%)
    5 / 112 (4.46%)
    5 / 107 (4.67%)
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    1 / 111 (0.90%)
    1 / 112 (0.89%)
    0 / 107 (0.00%)
         occurrences all number
    1
    1
    0
    Tympanic membrane disorder
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 112 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    Deafness neurosensory
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 112 (0.89%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    Otorrhoea
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 112 (0.89%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 112 (0.89%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 112 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Otitis media
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 112 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    otitis externa candida
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 112 (0.89%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 112 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2012
    • Revised the medical monitor for Canada and the United States and added contact information for medical monitors • Increased the number of study sites and add new countries
    20 Jun 2012
    • Added a new country to the list of countries for planned study sites • Updated procedure for return of study medication

    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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