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    Clinical Trial Results:
    Randomized, placebo-controlled, parallel group, double-blind, multi-center Phase III study to assess the inhibition of plaque formation of 0.1% octenidine mouthwash vs placebo in subjects with a gingival index ≤1.5

    Summary
    EudraCT number
    		 2017-001697-42
    Trial protocol
    		 DE  
    Global end of trial date
    14 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2020
    First version publication date
    05 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OML-III-A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03322124
    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, Schülke & Mayr GmbH, +49 40 52100-0, info@schuelke.com
    Scientific contact
    Clinical trials information, Schülke & Mayr GmbH, Schülke & Mayr GmbH, +49 40 52100-0, 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
    14 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstration of superiority of 0.1% octenidine mouthwash (OML, “Octenidin Mundspüllösung”) to placebo in the inhibition of plaque formation
    Protection of trial subjects
    The study was performed in accordance with the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP, CPMP/ICH/135/95), the appropriate national regulations and the Declaration of Helsinki. Before any study-related procedures were performed, the investigator obtained written informed consent from all subjects. The investigator ensured that the subject was fully informed (verbally and in writing) about the aims, procedures, potential risks, discomforts, and expected benefits of the clinical study. The subject had ample time to ask questions and to decide whether or not to participate. Only subjects that met all study inclusion criteria and none of the exclusion criteria were entered in the study. Participation in the study was voluntary and all subjects had the right to withdraw from the clinical study at any time and for any reason without any disadvantages for their medical care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2018
    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: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    101
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 3 centers in Germany. The first subject signed the informed consent form on 16-Jan-2018 and the last subject completed the study on 14-Dec-2018.

    Pre-assignment
    Screening details
    		 A total of 108 subjects were screened, of whom 7 subjects were screening failures.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OML arm
    Arm description
    		 0.1% octenidine mouthwash (OML)
    Arm type
    		 Experimental

    Investigational medicinal product name
    0.1% octenidine mouthwash
    Investigational medicinal product code
    Other name
    OML
    Pharmaceutical forms
    Mouthwash
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Subjects performed 10 applications of OML (mouth rinse with 10 mL OML for 30 s) over 5 days (3 times on Day 1, twice daily on Days 2-4, once on Day 5).

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Mouthwash
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Subjects performed 10 applications (mouth rinse with 10 mL placebo for 30 s) over 5 days (3 times on Day 1, twice daily on Days 2-4, once on Day 5).

    Number of subjects in period 1
    		OML arm Placebo arm
    Started
    77
    24
    Completed
    77
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OML arm
    Reporting group description
    		 0.1% octenidine mouthwash (OML)

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Reporting group values
    		 OML arm Placebo arm Total
    Number of subjects
    		 77 24 101
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 77 24 101
    Age continuous
    Units: years
        median (full range (min-max))
    		 25 (18 to 47) 24 (20 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 44 15 59
        Male
    		 33 9 42
    Gingival index
    Units: Subjects
        <= 1.0
    		 70 23 93
        > 1.0
    		 7 1 8
    Nicotine use
    Units: Subjects
        No
    		 50 20 70
        Yes
    		 27 4 31

    End points

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    End points reporting groups
    Reporting group title
    OML arm
    Reporting group description
    		 0.1% octenidine mouthwash (OML)

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Primary: Total mean plaque index after 5 days of treatment at Visit 2

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    End point title
    		 Total mean plaque index after 5 days of treatment at Visit 2 [1]
    End point description
    The thickness and extension of plaque along the gingival margin were assessed using the plaque index (PI) according to Silness and Löe, 1964. Evaluation of the PI was limited to “Ramfjord teeth” (16, 21, 24, 36, 41, 44 or their replacement teeth 17, 11, 25, 37, 31, 45). For each of the 4 surfaces a grade from 0 to 3 was given. The total mean PI was the sum of the individual grades divided by the number of investigated sites.
    End point type
    Primary
    End point timeframe
    Day 5
    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: Results of the statistical analysis could not be entered in the system. The superiority of OML over placebo in inhibiting plaque formation was demonstrated using the van Elteren test stratified by gingival status at Visit 1 and center (1-sided p-value <0.0001; point estimate -0.950 [median difference, OML minus placebo]).
    End point values
    		 OML arm Placebo arm
    Number of subjects analysed
    77
    24
    Units: total mean plaque index
        median (full range (min-max))
    0.380 (0.00 to 1.42)
    1.330 (0.33 to 1.96)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of first study drug administration (Day 1) until end of treatment (completion of study, Day 5).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    OML arm
    Reporting group description
    		 Subjects performed 10 mouth rinses with OML over 5 days.

    Reporting group title
    Placebo arm
    Reporting group description
    		 Subjects performed 10 mouth rinses with placebo over 5 days.

    Serious adverse events
    		 OML arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OML arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 77 (44.16%)
    6 / 24 (25.00%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    21 / 77 (27.27%)
    2 / 24 (8.33%)
         occurrences all number
    21
    2
    Headache
         subjects affected / exposed
    3 / 77 (3.90%)
    2 / 24 (8.33%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Tongue discolouration
         subjects affected / exposed
    5 / 77 (6.49%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0
    Oral discomfort
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2017
    To comply with requests from the German competent authority, the protocol was amended (protocol Version 3.0) to include a more detailed description of the required contraception measures.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2018
    The study was halted, since metallic (zinc) contaminants were found in a substance that was used for the solution of the study drug flavors. All study drug bottles at centers that were still recruiting subjects at this time were controlled for visible particles using the 4-eye principle, and if found, contaminated bottles were quarantined, and the center was supplied with new study drug. Study drug with no visible particles was considered safe. Patients who had already completed the study were informed about the study drug contamination.
    09 May 2018

    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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