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    Clinical Trial Results:
    Randomised, double-blind, vehicle controlled trial comparing Amphotericin B 100.000 I.E./g oral gel vs. Ampho-Moronal® suspension vs. modified vehicle to suspension in adult patients with oropharyngeal candidiasis

    Summary
    EudraCT number
    2013-000371-32
    Trial protocol
    DE  
    Global end of trial date
    11 Apr 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    14 May 2020
    First version publication date
    14 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13-02/AM-MG
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover Ring 7, Gruenwald, Germany, 82031
    Public contact
    Clinical Research Department, Dermapharm AG, Clinicaltrials.Dermapharm@dermapharm.com
    Scientific contact
    Clinical Research Department, Dermapharm AG, Clinicaltrials.Dermapharm@dermapharm.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
    08 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the safety and efficacy of a new dosage form containing Amphotericin B on an oral gel base in comparison to the approved Ampho-Moronal® suspension. The study aimed to show therapeutic non-inferiority of the test preparation compared to the reference preparation and superiority of both active medications over the vehicle.
    Protection of trial subjects
    The study was conducted in accordance with the principles of ICH GCP, the declaration of Helsinki, as well as all other applicable ethical and legal requirements. The reference product Ampho Moronal suspension is already registered for the application in the study indication and commercially available for years in Germany. For the purpose of approval the efficacy and safety of this medicinal product has already been shown in clinical trials. Any patient with lack of efficacy and/or deterioration of symptoms could stop treatment at any moment based on the clinical judgment of the investigator or on his/ her own request and without giving reasons. The planned procedures within the trial represented no special risks to the patients as, apart from usual medicinal practice procedures, no additional invasive procedures were planned.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Oct 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
    Germany: 391
    Worldwide total number of subjects
    391
    EEA total number of subjects
    391
    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)
    214
    From 65 to 84 years
    172
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    Multi-centric study in Germany; first volunteer enrolled: 11-Nov-2014; date of last completion: 11-Apr-2019

    Pre-assignment
    Screening details
    Diagnosis and main criteria for inclusion: Men and women aged ≥ 18 years; clinical signs and symptoms of oropharyngeal candidiasis (OPC) with a sum score of ≥ 4 of the parameters erythematous areas, removable white patches, soreness/burning and extent of oral lesions (single scores between 0 and 3); existence of predisposing risk factors for OPC

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The preparations were filled in brown glass bottles and labelled indistinguishably. All study preparations were coloured and contained flavouring substances. So the investigator and patients could not draw any conclusion from colour and flavour about the preparation with which they were treated.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test product
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Amphotericin B oral gel
    Investigational medicinal product code
    A07AA07
    Other name
    Pharmaceutical forms
    Oromucosal gel
    Routes of administration
    Buccal use
    Dosage and administration details
    1 g four times a day into the oral cavity

    Arm title
    Reference product
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Ampho-Moronal Suspension
    Investigational medicinal product code
    A07AA07
    Other name
    Pharmaceutical forms
    Oromucosal suspension
    Routes of administration
    Buccal use
    Dosage and administration details
    1 ml four times a day into the oral cavity

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Modified vehicle to reference product
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal suspension
    Routes of administration
    Buccal use
    Dosage and administration details
    1 g four times a day into the oral cavity

    Number of subjects in period 1
    Test product Reference product Vehicle
    Started
    126
    133
    132
    Completed
    113
    118
    114
    Not completed
    13
    15
    18
         Physician decision
    1
    4
    1
         Healing
    1
    -
    1
         Lack of efficacy
    1
    1
    2
         Adverse event, non-fatal
    6
    5
    6
         Consent withdrawn by subject
    3
    5
    4
         Lost to follow-up
    1
    -
    4
    Period 2
    Period 2 title
    Follow up
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test - Follow up
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Reference Follow up
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Vehicle Follow up
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Test - Follow up Reference Follow up Vehicle Follow up
    Started
    113
    118
    114
    Completed
    110
    111
    110
    Not completed
    3
    7
    4
         Consent withdrawn by subject
    3
    7
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Test product
    Reporting group description
    -

    Reporting group title
    Reference product
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -
    Reporting group title
    Test - Follow up
    Reporting group description
    -

    Reporting group title
    Reference Follow up
    Reporting group description
    -

    Reporting group title
    Vehicle Follow up
    Reporting group description
    -

    Primary: Primary endpoint

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    End point title
    Primary endpoint
    End point description
    The primary endpoint of the study was the clinical success rate at the end of treatment (Day 14). The success rate was defined as clinical and mycological cure. Clinical cure is gained when the total score of the 4 clinical parameters is ≤ 1 on Day 14 and no further treatment is necessary. Mycological cure is specified as a fungal culture score of ≤ 1 (only single forms of Candida albicans).
    End point type
    Primary
    End point timeframe
    Initial examination to main examination (EOT, day 14)
    End point values
    Test product Reference product Vehicle
    Number of subjects analysed
    105
    114
    106
    Units: percentage
    26
    49
    28
    Statistical analysis title
    Non-Inferiority
    Statistical analysis description
    The primary objective of this study was to show non-inferiority of the test product in comparison to the reference product. Non-inferiority was statistically proven if the lower limit of the two-sided 95% confidence interval (CI) was > -D, where Δ = 0.20 was the non-inferiority limit.
    Comparison groups
    Test product v Reference product
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Median difference (final values)
    Point estimate
    -18.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.41
         upper limit
    -5.03
    Statistical analysis title
    Superiority of test product to vehicle
    Statistical analysis description
    The analysis was intended to provide supportive evidence with regard to assay sensitivity.
    Comparison groups
    Test product v Vehicle
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval
    Notes
    [1] - Difference between success rates
    Statistical analysis title
    Superiority of reference product to vehicle
    Statistical analysis description
    This analysis was intended to provide supportive evidence with regard to assay sensitivity.
    Comparison groups
    Reference product v Vehicle
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.05
    Method
    Fisher exact
    Confidence interval
    Notes
    [2] - Difference between success rates

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to the end of follow-up.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Test product
    Reporting group description
    -

    Reporting group title
    Reference product
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Serious adverse events
    Test product Reference product Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    2 / 127 (1.57%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    Test product Reference product Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 125 (14.40%)
    26 / 130 (20.00%)
    25 / 127 (19.69%)
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 125 (0.00%)
    2 / 130 (1.54%)
    4 / 127 (3.15%)
         occurrences all number
    0
    2
    4
    Pyrexia
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood lactic acid increased
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Throat tightness
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 125 (1.60%)
    3 / 130 (2.31%)
    1 / 127 (0.79%)
         occurrences all number
    2
    3
    1
    Migraine
         subjects affected / exposed
    1 / 125 (0.80%)
    2 / 130 (1.54%)
    0 / 127 (0.00%)
         occurrences all number
    1
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 125 (0.80%)
    2 / 130 (1.54%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 125 (0.80%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    1
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 125 (0.80%)
    2 / 130 (1.54%)
    0 / 127 (0.00%)
         occurrences all number
    1
    2
    0
    Dry mouth
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces hard
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Glossodynia
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    3 / 125 (2.40%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    3
    1
    0
    Oesophageal pain
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Oral discomfort
         subjects affected / exposed
    2 / 125 (1.60%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Swollen tongue
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 125 (1.60%)
    2 / 130 (1.54%)
    0 / 127 (0.00%)
         occurrences all number
    2
    2
    0
    Renal and urinary disorders
    Urinary hesitation
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Lichen sclerosus
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    rash
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    1
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Stasis dermatitis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    1
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal candidiasis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Gonococcal infection
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 130 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    0
    1
    Urethritis
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 130 (0.77%)
    0 / 127 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 130 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    0

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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
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