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    Clinical Trial Results:
    A double-blind, double-dummy, prospective, randomized multiple-site study of oral Finafloxacin 300 mg b.i.d. versus oral Ciprofloxacin 250 mg b.i.d. in patients with lower uncomplicated UTI (uUTI) with a treatment duration of 3 days.

    Summary
    EudraCT number
    		 2007-007742-35
    Trial protocol
    		 DE  
    Global end of trial date
    14 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2018
    First version publication date
    23 Dec 2018
    Other versions
    Summary report(s)
    		 CSR Synopsis FINA-003

    Trial information

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    Trial identification
    Sponsor protocol code
    FINA-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00722735
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MerLion Pharmaceuticals GmbH
    Sponsor organisation address
    Robert-Roessle-Str. 10, Berlin, Germany, 13125
    Public contact
    Head Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
    Scientific contact
    Head Regulatory Affairs, MerLion Pharmaceuticals GmbH, lueckermann@merlionpharma.de
    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
    08 Feb 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.
    Protection of trial subjects
    Exclusion of subjects with abnormal ECG findings; continous monitoring with 12-lead ECG.
    Background therapy
    		 -
    Evidence for comparator
    		 Ciprofloxacin was chosen as a comparator since it is the most widely used fluoroquinolone in the treatment of urinary infections.
    Actual start date of recruitment
    08 Oct 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
    Germany: 24
    Country: Number of subjects enrolled
    Singapore: 12
    Worldwide total number of subjects
    36
    EEA total number of subjects
    24
    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)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled on 08-OCT-2008 and last patient completed on 14-MAY-2009 Countries: Germany and Singapore

    Pre-assignment
    Screening details
    		 After signing the informed consent patient received screening no. If these patients are eligible to continue the study, based on the inclusion and exclusion criteria they will be assigned to one of the two treatment groups (Finafloxacin or Ciprofloxacin in a ratio 2:1).

    Period 1
    Period 1 title
    Overall Trial (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
    Blinding was conducted using the double-dummy technique.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 Finafloxacin 300 mg b.i.d. for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finafloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Finafloxacin 300 mg b.i.d (6 X 50 mg tablets) + Ciprofloxacin pacebo (one capsule) b.i.d. for 3 days

    Arm title
    		 Comparator
    Arm description
    		 Ciprofloxacin 250 mg b.i.d for 3 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Ciprofloxacin, one capsule with 250 mg b.i.d. + Finafloxacin 6 placebo tablets b.i.d. for 3 days

    Number of subjects in period 1
    		Verum Comparator
    Started
    28
    8
    Completed
    25
    8
    Not completed
    3
    0
         Adverse event, non-fatal
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 36 36
    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)
    		 36 36
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.9 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients that received at least one dose of study medication

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All ITT patients with ≥10^5 cfu/ml in the predose culture, taken at least 5 doses of medication and had the primary endpoint measurement available at Visit 3.

    Subject analysis set title
    Sub-study group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The sub-cohort of patients in Singapore generated additional efficacy/pharmacokinetic data for bacterial killing rate.

    Subject analysis sets values
    		 Safety Set mITT Sub-study group
    Number of subjects
    36
    18
    8
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    36
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.9 ( 12.4 )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 Finafloxacin 300 mg b.i.d. for 3 days

    Reporting group title
    Comparator
    Reporting group description
    		 Ciprofloxacin 250 mg b.i.d for 3 days

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients that received at least one dose of study medication

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All ITT patients with ≥10^5 cfu/ml in the predose culture, taken at least 5 doses of medication and had the primary endpoint measurement available at Visit 3.

    Subject analysis set title
    Sub-study group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The sub-cohort of patients in Singapore generated additional efficacy/pharmacokinetic data for bacterial killing rate.

    Primary: Efficacy - Eradication

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    End point title
    		 Efficacy - Eradication [1]
    End point description
    The bacteriological eradication rate of Finafloxacin when compared to Ciprofloxacin in female patients with uUTI. Defined as the eradication of initial pathogen (≤ 10^3 cfu/mL) in urine at Visit 3 (day 4-6) with no isolation of a new pathogen.
    End point type
    Primary
    End point timeframe
    Days 4 - 6 after treatment start
    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: With respect to the evaluation of results, no confirmatory analyses were to be performed. The original intention was to show the preliminary efficacy of Finafloxacin as a proof of concept.
    End point values
    		 Verum Comparator mITT
    Number of subjects analysed
    28
    8
    36
    Units: percent
        number (not applicable)
    100
    100
    100
    No statistical analyses for this end point

    Primary: Efficacy - Killing rate (2h)

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    End point title
    		 Efficacy - Killing rate (2h) [2]
    End point description
    The primary efficacy variable of the sub-study was the bacterial killing rate at 2, 4, 8, and 24 hours (in the case of patients who enrolled after 2:00 p.m. on day 1) after the first intake of study medication. Rate of bacterial killing = actual bacterial concentration / (baseline bacterial concentration * time between samplings [h]) multiplied by 10^5
    End point type
    Primary
    End point timeframe
    24 hours
    Notes
    [2] - 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: With respect to the evaluation of results, no confirmatory analyses were to be performed. The original intention was to show the preliminary efficacy of Finafloxacin as a proof of concept.
    End point values
    		 Verum Comparator Sub-study group
    Number of subjects analysed
    5
    3
    8
    Units: Rate of bacterial killing
        arithmetic mean (standard deviation)
    240 ( 537 )
    45 ( 46 )
    167 ( 419 )
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point description
    Percent of subjects which reported at least one treatment emergent AE.
    End point type
    Secondary
    End point timeframe
    Treatment start (day 1) to day 28 - 38
    End point values
    		 Verum Comparator Safety Set
    Number of subjects analysed
    28
    8
    36
    Units: percent
        number (not applicable)
    57.1
    12.5
    47.2
    No statistical analyses for this end point

    Secondary: Efficacy - Superinfection

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    End point title
    		 Efficacy - Superinfection
    End point description
    Superinfection: isolation of a new pathogen (≥ 10^5 cfu/mL) on day 2 (Visit 2) or day 4-6 (Visit 3)
    End point type
    Secondary
    End point timeframe
    Treatments start to day 4-6
    End point values
    		 Verum Comparator mITT
    Number of subjects analysed
    13
    5
    18
    Units: Patients
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment start (day 1) to day 28 - 38
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 Finafloxacin 300 mg b.i.d. for 3 days

    Reporting group title
    Comparator
    Reporting group description
    		 Ciprofloxacin 250 mg b.i.d for 3 days

    Serious adverse events
    		 Verum Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Hypersensitivity
    Additional description: Allergy (facial swelling)
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Verum Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 28 (57.14%)
    1 / 8 (12.50%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Sciatica
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2009
    Clarification of exclusion criterion no. 13 (exclusion due to laboratory values) was added to the protocol.

    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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