Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase II study to assess bacterial count reduction of three Octenidine mouthwash concentrations in comparison to a placebo in patients with mild gingivitis

    Summary
    EudraCT number
    		 2013-002708-14
    Trial protocol
    		 DE  
    Global end of trial date
    17 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2021
    First version publication date
    09 Sep 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OML0113
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Schülke & Mayr GmbH
    Sponsor organisation address
    Robert-Koch-Straße 2, Norderstedt, Germany, 22851
    Public contact
    Clinical trials information, Schülke & Mayr GmbH, 49 40521000, info@schuelke.com
    Scientific contact
    Clinical trials information, Schülke & Mayr GmbH, 49 40521000, info@schuelke.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
    17 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to placebo
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2013
    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: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    88
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited at 2 clinical sites in Germany. The first patient was recruited on 28 Oct 2013 and the last patient on 7 Jan 2014.

    Pre-assignment
    Screening details
    		 105 patients were screened; 15 of which were not randomised because they did not meet the eligibility criteria.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OML 0.1% then placebo
    Arm description
    		 Treatment with OML 0.1% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.1%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.1%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.1% in Period 2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 OML 0.15% then placebo
    Arm description
    		 Treatment with OML 0.15% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.15%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.15%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.15% in Period 2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 OML 0.2% then placebo
    Arm description
    		 Treatment with OML 0.2% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.2%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.2%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.2% in Period 2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Number of subjects in period 1
    		OML 0.1% then placebo Placebo then OML 0.1% OML 0.15% then placebo Placebo then OML 0.15% OML 0.2% then placebo Placebo then OML 0.2%
    Started
    14
    15
    15
    15
    16
    15
    Completed
    14
    15
    15
    15
    16
    15
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OML 0.1% then placebo
    Arm description
    		 Treatment with OML 0.1% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.1%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.1% in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.1%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 OML 0.15% then placebo
    Arm description
    		 Treatment with OML 0.15% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.15%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.15% in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.15%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 OML 0.2% than placebo
    Arm description
    		 Treatment with OML 0.5% in Period 1, followed by placebo in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Arm title
    		 Placebo then OML 0.2%
    Arm description
    		 Treatment with placebo in Period 1, followed by OML 0.2% in Period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine dihydrochloride 0.2%
    Investigational medicinal product code
    OML
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Use of study drug twice daily (rinsing the oral cavity with 10 mL study drug for 30 s) over a period of 4.5 days.

    Number of subjects in period 2
    		OML 0.1% then placebo Placebo then OML 0.1% OML 0.15% then placebo Placebo then OML 0.15% OML 0.2% than placebo Placebo then OML 0.2%
    Started
    14
    15
    15
    15
    16
    15
    Completed
    14
    15
    15
    15
    16
    15

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 90 90
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 88 88
        From 65-84 years
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.4 ( 10.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 58
        Male
    		 32 32

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    OML 0.1% then placebo
    Reporting group description
    		 Treatment with OML 0.1% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.1%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.1% in Period 2

    Reporting group title
    OML 0.15% then placebo
    Reporting group description
    		 Treatment with OML 0.15% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.15%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.15% in Period 2

    Reporting group title
    OML 0.2% then placebo
    Reporting group description
    		 Treatment with OML 0.2% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.2%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.2% in Period 2
    Reporting group title
    OML 0.1% then placebo
    Reporting group description
    		 Treatment with OML 0.1% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.1%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.1% in Period 2

    Reporting group title
    OML 0.15% then placebo
    Reporting group description
    		 Treatment with OML 0.15% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.15%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.15% in Period 2

    Reporting group title
    OML 0.2% than placebo
    Reporting group description
    		 Treatment with OML 0.5% in Period 1, followed by placebo in Period 2

    Reporting group title
    Placebo then OML 0.2%
    Reporting group description
    		 Treatment with placebo in Period 1, followed by OML 0.2% in Period 2

    Subject analysis set title
    OML 0.1%, OML period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.1% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.1% in Period 2. Data are included for the OML period.

    Subject analysis set title
    OML 0.15%; OML period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.15% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.15% in Period 2. Data are included for the OML period.

    Subject analysis set title
    OML 0.2%; OML period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.2% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.2% in Period 2. Data are included for the OML period.

    Subject analysis set title
    OML 0.1%; placebo period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.1% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.1% in Period 2. Data from the placebo period are included.

    Subject analysis set title
    OML 0.15%; placebo period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.15% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.15% in Period 2. Data are included for the placebo period.

    Subject analysis set title
    OML 0.2%; placebo period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This analysis set included all patients receiving either OML 0.2% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.2% in Period 2. Data are included for the placebo period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients receiving placebo

    Subject analysis set title
    OML 0.1%
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients receiving OML 0.15%

    Subject analysis set title
    OML 0.15%
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients receiving OML 0.15%

    Subject analysis set title
    OML 0.20%
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients receiving OML 0.2%

    Primary: Bacterial count reduction factor in saliva

    		 Close Top of page
    End point title
    		 Bacterial count reduction factor in saliva
    End point description
    The bacterial count reduction factor in saliva was defined as the absolute difference in log10 values of bacterial counts before and 1 min after rinsing, compared intra-individually. The mean of all intra-individually compared data was calculated for each treatment group separately. The mean of the treatment groups were compared between the application of OML and placebo on Visit 1 (Day 0) or Visit 3 (V2 + 14 or 21 days), respectively.
    End point type
    Primary
    End point timeframe
    Bacterial count reduction factor in saliva over 4.5 days of treatment
    End point values
    		 OML 0.1%, OML period OML 0.15%; OML period OML 0.2%; OML period OML 0.1%; placebo period OML 0.15%; placebo period OML 0.2%; placebo period
    Number of subjects analysed
    29
    29
    31
    28
    30
    30
    Units: Reduction factor
        arithmetic mean (standard deviation)
    3.63 ( 2.11 )
    4.30 ( 2.06 )
    5.44 ( 2.02 )
    0.00 ( 0.70 )
    0.06 ( 0.73 )
    0.05 ( 0.71 )
    Statistical analysis title
    		 Primary analysis; OML 0.1% vs placebo
    Comparison groups
    OML 0.1%; placebo period v OML 0.1%, OML period
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Primary analysis; OML 0.15% vs placebo
    Comparison groups
    OML 0.15%; placebo period v OML 0.15%; OML period
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Primary analysis; OML 0.2% vs placebo
    Comparison groups
    OML 0.2%; OML period v OML 0.2%; placebo period
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Confidence interval

    Secondary: Plaque index, difference at Day 4

    		 Close Top of page
    End point title
    		 Plaque index, difference at Day 4
    End point description
    Thickness and extension of plaque were assessed for the “Ramfjord teeth”, for each of the 4 surfaces of the teeth, for the upper and lower jaw. The score ranges from 0 (no plaque) to 3 (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin). The total mean plaque index was the sum of the individual grades divided by the number of investigated sites. The plaque index for each tooth was the sum of the 4 individual grades divided by 4. The total mean plaque index could range from 0 to 3 with higher indices indicating more plaque.
    End point type
    Secondary
    End point timeframe
    After a rinsing period of 4 days
    End point values
    		 Placebo OML 0.1% OML 0.15% OML 0.20%
    Number of subjects analysed
    88
    29
    30
    31
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.58 ( 0.43 )
    0.52 ( 0.44 )
    0.43 ( 0.34 )
    0.42 ( 0.30 )
    No statistical analyses for this end point

    Secondary: Gingival index, mean difference between 2 visits (rinsing period of 4 days)

    		 Close Top of page
    End point title
    		 Gingival index, mean difference between 2 visits (rinsing period of 4 days)
    End point description
    After gingival bleeding was provoked, the gingival index (GI) was assessed for the upper and lower jaw, 4 sites (buccal, mesial, distal, lingual) of the “Ramfjord teeth”, with the GI ranking from 0 to 3, with 0 for normal gingiva and 3 for severely inflammed gingiva. For each of the 4 sites a grade from 0 to 3 was given. The total mean GI was the sum of the individual grades divided by the number of investigated sites. The GI for each tooth was the sum of the 4 individual grades divided by 4. The total mean GI could range from 0 to 3 with higher indices indicating a worse gingival condition. The mean difference of GI between 2visits was assesed. Negative values indicate a worsening of the condition.
    End point type
    Secondary
    End point timeframe
    Rinsing period of 4 days
    End point values
    		 Placebo OML 0.1% OML 0.15% OML 0.20%
    Number of subjects analysed
    88
    29
    30
    31
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.24 ( 0.35 )
    0.00 ( 0.27 )
    0.14 ( 0.24 )
    0.12 ( 0.25 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected up to the last dose of study medication in Period 2 plus 14 days.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    OML 0.1%, OML period
    Reporting group description
    		 All patients receiving either OML 0.1% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.1% in Period 2. Data are included for the OML period.

    Reporting group title
    OML 0.1%; placebo period
    Reporting group description
    		 All patients receiving either OML 0.1% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.1% in Period 2. Data from the placebo period are included.

    Reporting group title
    OML 0.15%; OML period
    Reporting group description
    		 All patients receiving either OML 0.15% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.15% in Period 2. Data are included for the OML period.

    Reporting group title
    OML 0.15%; placebo period
    Reporting group description
    		 All patients receiving either OML 0.15% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.15% in Period 2. Data are included for the placebo period.

    Reporting group title
    OML 0.2%; OML period
    Reporting group description
    		 All patients receiving either OML 0.2% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.2% in Period 2. Data are included for the OML period.

    Reporting group title
    OML 0.2%; placebo period
    Reporting group description
    		 All patients receiving either OML 0.2% in Period 1 followed by placebo in Period 2, or placebo in Period 1 followed by OML 0.2% in Period 2. Data are included for the placebo period.

    Serious adverse events
    		 OML 0.1%, OML period OML 0.1%; placebo period OML 0.15%; OML period OML 0.15%; placebo period OML 0.2%; OML period OML 0.2%; placebo period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 OML 0.1%, OML period OML 0.1%; placebo period OML 0.15%; OML period OML 0.15%; placebo period OML 0.2%; OML period OML 0.2%; placebo period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 29 (41.38%)
    6 / 29 (20.69%)
    11 / 30 (36.67%)
    3 / 30 (10.00%)
    16 / 31 (51.61%)
    4 / 31 (12.90%)
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Burning sensation mucosal
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Ageusia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Migraine
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Device failure
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Breath odour
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Tongue discolouration
         subjects affected / exposed
    5 / 29 (17.24%)
    0 / 29 (0.00%)
    5 / 30 (16.67%)
    0 / 30 (0.00%)
    10 / 31 (32.26%)
    0 / 31 (0.00%)
         occurrences all number
    5
    0
    5
    0
    10
    0
    Tooth discolouration
         subjects affected / exposed
    7 / 29 (24.14%)
    1 / 29 (3.45%)
    6 / 30 (20.00%)
    1 / 30 (3.33%)
    8 / 31 (25.81%)
    0 / 31 (0.00%)
         occurrences all number
    7
    1
    6
    1
    8
    0
    Dental caries
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tooth deposit
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gingival inflammation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in jaw
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    2 / 31 (6.45%)
    1 / 31 (3.23%)
         occurrences all number
    2
    2
    1
    0
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    More information

    		 Close Top of page

    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
    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.

    European Medicines Agency © 1995-Sat May 04 09:25:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA