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    Clinical Trial Results:
    Therapeutic clinical trial of three types of “Phlogosol concentrate for gargle” products, comparing their efficacy in reducing different inflammations of the oral cavity. (Changing the active ingredient of “Phlogosol concentrate for gargle” of oral cavity from hexachlorophene to chlorhexidine, the two products with different active ingredients in a non-inferiority clinical trial in comparison to the third control product.)

    Summary
    EudraCT number
    		 2013-002190-22
    Trial protocol
    		 HU  
    Global end of trial date
    21 Oct 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    Phlogosol_2013/01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PannonPharma Ltd.
    Sponsor organisation address
    PannonPharma ut 1., Pecsvarad, Hungary, 7720
    Public contact
    Head of Research and Development Department, PannonPharma Ltd., clinical.trials@pannonpharma.hu
    Scientific contact
    Head of Research and Development Department, PannonPharma Ltd., clinical.trials@pannonpharma.hu
    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
    16 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cure or healing improvement in inflammations of oral cavity mucosa
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, and ethical principles stated in the Declaration of Helsinki. All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2014
    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
    Hungary: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    62
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 1 investigational site located in Hungary, from 11 Aug 2014 to 21 Oct 2014.

    Pre-assignment
    Screening details
    		 Patients of both sexes aged 18 years or older suffering from local inflammatory changes of the oral cavity

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phlogosol Solution
    Arm description
    		 Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Phlogosol Solution for external use only
    Investigational medicinal product code
    Other name
    Phlogosol külsőleges oldat
    Pharmaceutical forms
    Concentrate for gargle
    Routes of administration
    Oromucosal use, Oropharyngeal use
    Dosage and administration details
    Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Arm title
    		 Phlogosol Uno
    Arm description
    		 Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Phlogosol Uno 30 mg/ml concentrate for gargle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for gargle
    Routes of administration
    Oromucosal use, Oropharyngeal use
    Dosage and administration details
    Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Arm title
    		 Phlogosol Duo
    Arm description
    		 Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phlogosol Duo 30 mg/2 mg/ml concentrate for gargle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for gargle
    Routes of administration
    Oromucosal use, Oropharyngeal use
    Dosage and administration details
    Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Number of subjects in period 1
    		Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Started
    26
    28
    26
    Completed
    25
    25
    25
    Not completed
    1
    3
    1
         Protocol deviation
    1
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phlogosol Solution
    Reporting group description
    		 Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Uno
    Reporting group description
    		 Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Duo
    Reporting group description
    		 Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo Total
    Number of subjects
    		 26 28 26 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 21 23 18 62
        From 65-84 years
    		 5 5 8 18
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.12 ( 21.087 ) 46.54 ( 21.049 ) 49.35 ( 19.978 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 15 16 50
        Male
    		 6 10 9 25
        Not recorded
    		 1 3 1 5

    End points

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    End points reporting groups
    Reporting group title
    Phlogosol Solution
    Reporting group description
    		 Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Uno
    Reporting group description
    		 Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Duo
    Reporting group description
    		 Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Primary: Reduction in the size of inflamed area

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    End point title
    		 Reduction in the size of inflamed area
    End point description
    Area of inflammation in oral cavity was measured at Baseline (Visit 1) and after 7 days treatment (Visit 2). Changing in size of inflamed area from Visit 1 to Visit 2 was calculated. Negative values show decrease and positive values show increase in size of inflamed area, 0 represents no change.
    End point type
    Primary
    End point timeframe
    From Baseline (Visit 1) to Day 7 (Visit 2)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    23
    23
    25
    Units: mm
        arithmetic mean (standard deviation)
    -4.91 ( 9.113 )
    -5.67 ( 8.146 )
    -5.52 ( 7.886 )
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    Since data from different groups did not show normal distributions, in order to comparison of reduction in the size of inflamed area in group-pairs Mann-Whitney U-test (nonparametric counterpart of unpaired sample t-test) was used. Because of multiple comparisons Bonferroni correction was applied. Primary end point was to investigate non-inferiority of Phlogosol Duo and Phlogosol Solution. P-values for other group-pair comparisons see in Notes.
    Comparison groups
    Phlogosol Solution v Phlogosol Uno v Phlogosol Duo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.45 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - P-value for Phlogosol solution and Phlogosol Uno comparison p=0.500 P-value for Phlogosol Duo and Phlogosol Uno comparison p=0.702 Significance threshold is p<0.017 with Bonferroni correction

    Secondary: Extent, painfulness and degree of inflammation

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    End point title
    		 Extent, painfulness and degree of inflammation
    End point description
    Extent, painfulness and degree of inflammation were assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    25
    25
    25
    Units: number of subjects
        significantly decreased
    10
    11
    15
        decreased
    8
    10
    8
        unchanged
    5
    3
    2
        worsened
    2
    1
    0
    No statistical analyses for this end point

    Secondary: Status of oral hygiene

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    End point title
    		 Status of oral hygiene
    End point description
    Status of oral hygiene was assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    25
    25
    25
    Units: number of subjects
        good (Visit 1)
    13
    12
    14
        moderate (Visit 1)
    12
    12
    11
        inadequate (Visit 1)
    0
    1
    0
        good (Visit 2)
    15
    16
    18
        moderate (Visit 2)
    10
    8
    7
        inadequate (Visit 2)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Degree of pain

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    End point title
    		 Degree of pain
    End point description
    Degree of pain was assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    25
    25
    24 [2]
    Units: number of subjects
        No pain (Visit 1)
    7
    10
    10
        Mild (Visit 1)
    11
    9
    9
        Moderate (Visit 1)
    6
    5
    5
        Severe (Visit 1)
    1
    1
    1
        No pain (Visit 2)
    20
    19
    16
        Mild (Visit 2)
    3
    5
    7
        Moderate (Visit 2)
    1
    1
    1
        Severe (Visit 2)
    1
    0
    0
    Notes
    [2] - Visit 1 (N=25), Visit 2 (N=24)
    No statistical analyses for this end point

    Secondary: Degree of pain on VAS (Visual analog scale)

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    End point title
    		 Degree of pain on VAS (Visual analog scale)
    End point description
    On the VAS scale: 0 cm = no pain and 10 cm = extreme pain
    End point type
    Secondary
    End point timeframe
    At Baseline and during the 7 day period of treatment (Day 1-7)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    25 [3]
    25 [4]
    25
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (N=25,25,25)
    3.46 ( 2.304 )
    3.56 ( 2.805 )
    3.63 ( 2.428 )
        Day 1 (N=25,25,25)
    3.46 ( 2.304 )
    3.58 ( 2.841 )
    3.52 ( 2.21 )
        Day 2 (N=25,25,25)
    3.31 ( 2.452 )
    3.54 ( 2.71 )
    3.32 ( 2.191 )
        Day 3 (N=24,25,25)
    2.84 ( 2.098 )
    2.98 ( 2.593 )
    3.02 ( 2.187 )
        Day 4 (N=24,25,25)
    2.51 ( 1.973 )
    2.68 ( 2.364 )
    2.52 ( 2.03 )
        Day 5 (N=23,25,25)
    1.91 ( 1.305 )
    2.24 ( 1.837 )
    2.27 ( 1.726 )
        Day 6 (N=23,24,25)
    1.89 ( 1.333 )
    2 ( 1.841 )
    1.93 ( 1.633 )
        Day 7 (N=23,24,25)
    1.7 ( 1.358 )
    1.78 ( 1.903 )
    1.88 ( 1.655 )
    Notes
    [3] - At the end of treatment N=23
    [4] - At the end of treatment N=24
    No statistical analyses for this end point

    Secondary: Hyperaemia, Swelling, Erosio, Ulceratio

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    End point title
    		 Hyperaemia, Swelling, Erosio, Ulceratio
    End point description
    Incidence of Hyperaemia, Swelling, Erosio and Ulceration were assessed at Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point type
    Secondary
    End point timeframe
    At Baseline (Visit 1) and after 7 days treatment (Visit 2)
    End point values
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Number of subjects analysed
    25
    25
    25
    Units: Incidence
        Hyperaemia (Visit 1)
    25
    25
    25
        Swelling (Visit 1)
    14
    13
    13
        Erosio (Visit 1)
    3
    6
    5
        Ulceratio (Visit 1)
    2
    1
    2
        Hyperaemia (Visit 2)
    14
    13
    10
        Swelling (Visit 2)
    9
    6
    7
        Erosio (Visit 2)
    2
    3
    4
        Ulceratio (Visit 2)
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the entire study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Phlogosol Solution
    Reporting group description
    		 Subject who received Phlogosol Solution with 30 mg/ml sodium samarium disulfosalicylate active substance and 1 mg/ml hexachlorophene antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Uno
    Reporting group description
    		 Subject who received Phlogosol Uno with 30 mg/ml sodium samarium disulfosalicylate active substance without antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Reporting group title
    Phlogosol Duo
    Reporting group description
    		 Subject who received Phlogosol Duo with 30 mg/ml sodium samarium disulfosalicylate active substance and 2 mg/ml chlorhexidine gluconate antiseptic agent. Add 10 ml of investigational medicinal product to 1 dl water, rinsing for 1 minute three times daily after toothbrushing, for a period of 7 days.

    Serious adverse events
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 28 (0.00%)
    0 / 26 (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: 3.5%
    Non-serious adverse events
    		 Phlogosol Solution Phlogosol Uno Phlogosol Duo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
    General disorders and administration site conditions
    Application site dryness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Application site redness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Application site burn
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 28 (3.57%)
    0 / 26 (0.00%)
         occurrences all number
    1
    1
    0
    Application site anaesthesia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 28 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    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
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