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    Clinical Trial Results:
    A Preliminary Randomised Controlled Trial using Standard Therapy Vs Mugard

    Summary
    EudraCT number
    		 2010-019953-16
    Trial protocol
    		 GB  
    Global end of trial date
    16 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2019
    First version publication date
    31 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1009435
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Devon and Exeter NHS Foundation Trust
    Sponsor organisation address
    Barrback Rd, Exeter, United Kingdom, EX2 5DW
    Public contact
    Clinical Trials Department, Royal Devon and Exeter NHS Foundation Trust, 01392 402215, clairebarber2@nhs.net
    Scientific contact
    Clinical Trials Department, Royal Devon and Exeter NHS Foundation Trust, 01392 402215, clairebarber2@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Does the use of Mugard in the management of patients with chemotherapy and/or radiotherapy-induced oral mucositis (severe intraoral ulceration), offer significant advantage in reducing the time of onset, duration or severity of intraoral lesions?
    Protection of trial subjects
    Patient information sheets, patient questionnaires and weekly assessments with in between telephone contact if needed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2011
    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
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 QUESTIONNAIRES

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Mugard
    Arm description
    		 Mugard is the new treatment undergoing investigation compared with benzydamine standard therapy
    Arm type
    		 standard intervention

    Investigational medicinal product name
    mugard
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Mouthwash
    Routes of administration
    Buccal use
    Dosage and administration details
    SWISH AND SPIT AS DIRECTED ON PRESCRIPTION

    Number of subjects in period 1
    		Mugard
    Started
    16
    Completed
    16

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Mugard
    Reporting group description
    		 Mugard is the new treatment undergoing investigation compared with benzydamine standard therapy

    Subject analysis set title
    benzydamine difflam
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    intention to treat

    Primary: • Delay onset, reduce severity and reduce duration of intra-oral lesions

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    End point title
    		 • Delay onset, reduce severity and reduce duration of intra-oral lesions
    End point description
    End point type
    Primary
    End point timeframe
    weekly assessment
    End point values
    		 Mugard benzydamine difflam
    Number of subjects analysed
    8
    8
    Units: RTOG Scoring
        number (not applicable)
    0
    8
    Statistical analysis title
    		 none done due to low numbers
    Statistical analysis description
    trial ended early due to withdrawal of investigative product
    Comparison groups
    Mugard v benzydamine difflam
    Number of subjects included in analysis
    16
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.01 [2]
    Method
    		 no analysis
    Parameter type
    		 no analysis
    Confidence interval
    Notes
    [1] - not done
    [2] - no analysis

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    as per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Serious adverse event
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no NSAE within the trial
    Serious adverse events
    		 Serious adverse event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Musculoskeletal and connective tissue disorders
    Hip disarticulation
    Additional description: fell at home not related to investigation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Serious adverse event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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