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    Clinical Trial Results:
    A randomised, multi-centre, parallel group, double-blind, placebo- and active-controlled clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat.

    Summary
    EudraCT number
    		 2012-002876-15
    Trial protocol
    		 DE  
    Global end of trial date
    09 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2022
    First version publication date
    25 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MCMK0112
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassella-med GmbH & Co. KG
    Sponsor organisation address
    Gereonsmuehlengasse 1, Cologne, Germany, 50670
    Public contact
    Clinical Operations, Cassella-med GmbH & Co KG, +49 8001652200, dialog@cassella-med.eu
    Scientific contact
    Clinical Operations, Cassella-med GmbH & Co KG, clinical.operations@klosterfrau.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
    14 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives are to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders, and to demonstrate non-inferiority of Octenidine lozenges compared with active comparator (neo angin®) in terms of the rate of responders. Response is defined as a score of 4 or 5 on the Pain Relief Rating Scale (PRRS) (patient assessment) at visit 3 (study day 3 or 4, LOCF) and a total score of 0 or 1 on the Tonsillo-Pharyngitis Score (TPS) (investigator assessment) at visit 3 (study day 3 or 4, LOCF). Both primary objectives are efficacy objectives
    Protection of trial subjects
    Subjects were during the trial continuously under the supervision of an physician or an experienced nurse. If, in the opinion of the investigator, antibiotic treatment was indicated during the study, the patient was excluded and not allowed to continue the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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: 740
    Worldwide total number of subjects
    740
    EEA total number of subjects
    740
    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)
    87
    Adults (18-64 years)
    653
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Three winter periods (2012/2013; 2013/2014 and 2014/2015) were required to complete the recruitment of sufficient amount of patients. Study subjects were recruited from September 2012 through February 2015.

    Pre-assignment
    Screening details
    		 Prior to study enrolment, the investigator informed each patient in detail about the study and they were given the Patient Information. After the patients have voluntary singed the consent form, they were screened by confirming all inclusion and exclusion criteria.

    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
    Blinding implementation details
    Octenidine, placebo and active comparator were provided as indistinguishable lozenges. Sealed individual random code envelopes were prepared for the purpose of individual unblinding of a patient's treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Octenidine
    Arm description
    		 All patients randomized and treated with Octenidine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octenidine lozenges
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Octenidine lozenges were provided as lozenges containing 0.1% Octenidine. One lozenge was to be taken every 2 to 3 hours, so that a total of 6 lozenges were taken within 24 hours. The lozenge was not to be swallowed immediately, but kept in the mouth until it was fully dissolved.

    Arm title
    		 Placebo
    Arm description
    		 All patients treated with Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo contained the same ingredients as the Octenidine lozenges, except for Octenidine. One lozenge was to be taken every 2 to 3 hours, so that a total of 6 lozenges were taken within 24 hours. The lozenge was not to be swallowed immediately, but kept in the mouth until it was fully dissolved.

    Arm title
    		 Neo-Angin
    Arm description
    		 All patients treated with Neo-Angin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neo-Angin
    Investigational medicinal product code
    Neo-Angin
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Other use
    Dosage and administration details
    Active comparator (Neo-Angin) was provided as the product that is marketed in Germany but without the ingrdient providing red colour (Batch No. 717052). This ingredient (Ponceau 4R) is pharmacologically irrelevant. One lozenge was to be taken every 2 to 3 hours so that a total of 6 lozenges were taken within 24 hours. The lozenge was not to be swallowed immediately but was to be kept in mouth until it is fully dissolved.

    Number of subjects in period 1 [1]
    		Octenidine Placebo Neo-Angin
    Started
    341
    186
    192
    Completed
    329
    180
    186
    Not completed
    12
    6
    6
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    9
    3
    2
         Additional treatment required
    -
    1
    2
         Randomization failure
    2
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported as being in the baseline period are the same as the number of patients enrolled, but different from the number of patients randomized. Statistical analyses were carried out with the randomized patients of the three treatment arms, thus here the number of randomized patients was considered.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Efficacy results of the full Analysis set (FAS)

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 719 719
    Age categorical
    All patients categorized by age
    Units: Subjects
        Adolescents (12-17 years)
    		 83 83
        Adults (>= 18 years)
    		 636 636
    Gender categorical
    All patients of the full analysis set categorized by gender
    Units: Subjects
        Male
    		 0 0
        Female
    		 0 0
        not recorded
    		 719 719

    End points

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    End points reporting groups
    Reporting group title
    Octenidine
    Reporting group description
    		 All patients randomized and treated with Octenidine

    Reporting group title
    Placebo
    Reporting group description
    		 All patients treated with Placebo

    Reporting group title
    Neo-Angin
    Reporting group description
    		 All patients treated with Neo-Angin

    Primary: Superiority of Octenidine lozenges compared with placebo

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    End point title
    		 Superiority of Octenidine lozenges compared with placebo [1]
    End point description
    The primary objectives were to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders. Response was defined as a score of 4 or 5 on the Pain Relief Rating Scale (PRRS) (patient assessment) at visit 3 (Study Day 3 or 4, LOCF) and a total score of 0 or 1 on the Tonsillo-Pharyngitis Score (TPS) (investigator assessment) at visit 3 (Study Day 3 or 4, LOCF).
    End point type
    Primary
    End point timeframe
    From visit 1 through visit 3 (study day 0 through study day 3 or 4)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Superiority of Octenidine lozenges refers only to placebo and not to comparator.
    End point values
    		 Octenidine Placebo
    Number of subjects analysed
    341
    186
    Units: number of subjects
        Responder
    194
    81
        Non-responder
    147
    105
    Statistical analysis title
    		 Full analysis set
    Statistical analysis description
    Treatment response of the superiority group
    Comparison groups
    Octenidine v Placebo
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.0031 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 22.2
    Variability estimate
    Standard deviation
    Notes
    [2] - The study was planned using an adaptive 2-stage group sequential design with possible sample size adjustment after the planned Interim Analysis.
    [3] - p-value for difference Octenidine vs. resp. group

    Primary: Non-inferiority of Octenidine lozenges compared with active comparator

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    End point title
    		 Non-inferiority of Octenidine lozenges compared with active comparator [4]
    End point description
    Non-inferiority of Octenidine lozenges compared with active comparator (neo-angin) in terms of the rate of responders. Response was defined as a score of 4 or 5 on the Pain Relief Rating Scale (PRRS) (patient assessment) at visit 3 (Study Day 3 or 4, LOCF) and a total score of 0 or 1 on the Tonsillo-Pharyngitis Score (TPS) (investigator assessment) at visit 3 (Study Day 3 or 4, LOCF).
    End point type
    Primary
    End point timeframe
    From visit 1 through visit 3 (study day 0 through study day 3 or 4)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Non-inferiority of Octenidine lozenges refers only to comparator and not to placebo.
    End point values
    		 Octenidine Neo-Angin
    Number of subjects analysed
    341
    192
    Units: number of subjects
        Responder
    194
    104
        Non-Responder
    147
    88
    Statistical analysis title
    		 Full analysis set
    Statistical analysis description
    Treatment Response of the non-inferiority group.
    Comparison groups
    Octenidine v Neo-Angin
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 0.51 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 11.8
    Variability estimate
    Standard deviation
    Notes
    [5] - The study was planned using an adaptive 2-stage group sequential design with possible sample size adjustment after the planned Interim Analysis.
    [6] - p-value for difference Octenidine vs. resp. group

    Secondary: Pain Relief Rating Scale (PRRS) - rate of patients with pain relief

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    End point title
    		 Pain Relief Rating Scale (PRRS) - rate of patients with pain relief
    End point description
    Rate of patients with pain relief at study day 1, 2, and 3/4. The patients were to be asked to assess the PRRS for sore throat using a 5 step rating scale. The results are representing the number of patients with any pain relief (PRRS score 1 to 5).
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 2 through visit 3 (study day 1 through study day 3 or 4).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    341
    186
    192
    Units: number of subjects
        Study day 1
    271
    147
    160
        Study day 2
    312
    173
    179
        Study day 3/4
    304
    166
    175
    No statistical analyses for this end point

    Secondary: Tonsillo-Pharyngitis Score (TPS) - rate of patients with improvement

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    End point title
    		 Tonsillo-Pharyngitis Score (TPS) - rate of patients with improvement
    End point description
    The local findings in the pharynx using the TPS(10) by assessment of investigators. The results are representing rate of patients with improvement at study day 1 and study day 3/4.
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 2 through visit 3 (study day 1 through study day 3 or 4).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    341
    186
    192
    Units: number of subjects
        Study day 1
    219
    131
    132
        Study day 3/4
    331
    177
    181
    No statistical analyses for this end point

    Secondary: Tonsillo-Pharyngitis Score (TPS) - mean change at Visit 2

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    End point title
    		 Tonsillo-Pharyngitis Score (TPS) - mean change at Visit 2
    End point description
    The local findings in the pharynx using the TPS(10) by assessment of investigators. Results are representing the mean change from baseline at Visit 2 (study day 1).
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 1 through visit 2 (study day 0 to study day 1).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    338
    184
    191
    Units: other
        arithmetic mean (standard deviation)
    -1.0 ( 1.1 )
    -1.3 ( 1.2 )
    -1.0 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Tonsillo-Pharyngitis Score (TPS) - mean change at Visit 3

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    End point title
    		 Tonsillo-Pharyngitis Score (TPS) - mean change at Visit 3
    End point description
    The local findings in the pharynx using the TPS(10) by assessment of investigators. Results are representing the mean change from baseline at Visit 3 (study day 3/4).
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 1 through visit 3 (study day 0 through study day 3 or 4).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    338
    183
    187
    Units: other
        arithmetic mean (standard deviation)
    -3.3 ( 1.4 )
    -3.4 ( 1.7 )
    -3.0 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Visual Analogue Scales (VAS) - mean change at Visit 2

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    End point title
    		 Visual Analogue Scales (VAS) - mean change at Visit 2
    End point description
    Mean change from baseline at visit 2 with regard to Sum of VAS at rest and VAS when swallowing [cm].
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 1 through visit 2 (study day 0 through study day 1).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    338
    184
    191
    Units: other
        arithmetic mean (standard deviation)
    -3.19 ( 2.90 )
    -3.04 ( 2.67 )
    -3.21 ( 3.13 )
    No statistical analyses for this end point

    Secondary: Visual Analogue Scales (VAS) - mean change at Visit 3

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    End point title
    		 Visual Analogue Scales (VAS) - mean change at Visit 3
    End point description
    Mean change from baseline at visit 3 with regard to Sum of VAS at rest and VAS when swallowing [cm].
    End point type
    Secondary
    End point timeframe
    Course of the study from visit 1 through visit 3 (study day 0 through study day 3 or 4).
    End point values
    		 Octenidine Placebo Neo-Angin
    Number of subjects analysed
    333
    183
    187
    Units: other
        arithmetic mean (standard deviation)
    -10.53 ( 3.85 )
    -10.19 ( 4.41 )
    -10.16 ( 4.04 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are to be reported during exposure to study medication from study day 0 through study day 3/4.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Octenidine
    Reporting group description
    		 All patients received at least one treatment emergent Adverse Event in the Octenidine group

    Reporting group title
    Neo-Angin
    Reporting group description
    		 All patients received at least one treatment emergent Adverse Event in the Neo-Angin group.

    Reporting group title
    Placebo
    Reporting group description
    		 All patients received at least one treatment emergent Adverse Event in the placebo group.

    Serious adverse events
    		 Octenidine Neo-Angin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain lower
    Additional description: One patient in the neo-angin group reported an SAE of abdominal pain lower and was hospitalised with suspected appendicitis.
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Octenidine Neo-Angin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 344 (8.72%)
    15 / 191 (7.85%)
    8 / 188 (4.26%)
    Investigations
    Sputum abnormal
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    14 / 344 (4.07%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    14
    2
    1
    Headache
         subjects affected / exposed
    0 / 344 (0.00%)
    2 / 191 (1.05%)
    0 / 188 (0.00%)
         occurrences all number
    14
    2
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 344 (0.87%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    13
    5
    1
    Diarrhoea
         subjects affected / exposed
    3 / 344 (0.87%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Nausea
         subjects affected / exposed
    3 / 344 (0.87%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Dry mouth
         subjects affected / exposed
    2 / 344 (0.58%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Vomiting
         subjects affected / exposed
    3 / 344 (0.87%)
    0 / 191 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Dyspepsia
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 191 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 191 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Flatulence
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Glossodynia
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    13
    5
    1
    Paraesthesia oral
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    13
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 344 (0.87%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    3
    4
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 191 (0.52%)
    1 / 188 (0.53%)
         occurrences all number
    3
    4
    2
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    3
    4
    2
    Productive cough
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    3
    4
    2
    Musculoskeletal and connective tissue disorders
    Tendonitis
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 344 (0.58%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    8
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 344 (0.87%)
    0 / 191 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    8
    4
    4
    Rhinitis
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 191 (0.52%)
    1 / 188 (0.53%)
         occurrences all number
    8
    4
    4
    Sinusitis
         subjects affected / exposed
    1 / 344 (0.29%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    8
    4
    4
    Tonsillitis
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    8
    4
    4
    Herpes zoster
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    8
    4
    4
    Laryngitis
         subjects affected / exposed
    0 / 344 (0.00%)
    1 / 191 (0.52%)
    0 / 188 (0.00%)
         occurrences all number
    8
    4
    4
    Pharyngitis
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    8
    4
    4
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 344 (0.29%)
    0 / 191 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    8
    4
    4
    Pharyngeal hypoaesthesia
         subjects affected / exposed
    0 / 344 (0.00%)
    0 / 191 (0.00%)
    1 / 188 (0.53%)
         occurrences all number
    3
    4
    2

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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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