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    Clinical Trial Results:
    Intraepithelial neoplasia detection rate after single oral dose of methylene blue MMX® modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy.

    Summary
    EudraCT number
    		 2011-005693-36
    Trial protocol
    		 IT  
    Global end of trial date
    04 Jul 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2022
    First version publication date
    29 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CB-17/01/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01520324
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cosmo Technologies Ltd
    Sponsor organisation address
    42-43 Amiens Street, Dublin 1, D1, Ireland, Dublin, Ireland,
    Public contact
    Dipartimento di Gastroenterologia, IRCCS HUMANITAS, 0039 0282244771, sduggan@cosmopharma.com
    Scientific contact
    Dipartimento di Gastroenterologia, IRCCS HUMANITAS, 0039 0282244771, sduggan@cosmopharma.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
    30 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Detection rate evaluation of intraepithelial tumors
    Protection of trial subjects
    The present study was a descriptive non comparative study. No power calculation was performed to calculate the sample size. The study enrolment lasted up to completion of the screening of all potentially eligible clinical centre’s patients. On the basis of the medical records of the clinical centre, the number of potentially eligible patients known at the centre was lower than 100.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    07 Jan 2012
    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
    Italy: 59
    Worldwide total number of subjects
    59
    EEA total number of subjects
    59
    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)
    56
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at the Instituto Clinico Humanitas in Italy. First patient enrolled on 20Jan2012. Last patient completed study on 04Jul2012. The study enrolment lasted up to completion of the screening of all potentially eligible clinical centre’s patients. The number of potentially eligible patients known at the centre was lower than 100.

    Pre-assignment
    Screening details
    		 The investigator included 59 subjects in the study and 53 of them were treated. Fifty-two (52) subjects completed all study procedures. After inclusion, 6 subjects withdrew their consent and discontinued the study. After treatment, the investigator discontinued one subject due to moderate illness activity and due to poor bowel cleansing.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Patients with UC Undergoing Colonoscopy
    Arm description
    		 Oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy
    Arm type
    		 Open Label

    Investigational medicinal product name
    Methylene Blue MMX Tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During the intake of Selg 1000® solution a single oral dose of 200 mg of Methylene blue MMX® 25 mg modified release tablets will be taken. For the intake of 200 mg, each subject will receive a total of 8 Methylene blue MMX® 25 mg modified release tablets. The administration of the predefined amount of tablets will take place during and at the end of the intake of the bowel cleansing preparation.

    Number of subjects in period 1
    		Patients with UC Undergoing Colonoscopy
    Started
    59
    Completed
    52
    Not completed
    7
         Physician decision
    1
         Consent withdrawn by subject
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 59 59
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 56 56
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 35 35
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 168.9 ( 8.4 ) -
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 70.04 ( 9.57 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as all enrolled subjects who received at least one dose of the study drug. This population was used for safety evaluation.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled subjects who fulfilled the study protocol requirements in terms of study drug intake and collection of primary efficacy data, without major deviations that could affect study results.

    Subject analysis sets values
    		 Full Analysis Set Safety Population Per Protocol Population
    Number of subjects
    52
    53
    50
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    51
    50
    50
        From 65-84 years
    2
    2
    2
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Height
    Units: cm
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Patients with UC Undergoing Colonoscopy
    Reporting group description
    		 Oral delivery mucosal stain: 200mg methylene blue MMX tablet taken prior to colonoscopy

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All enrolled subjects, who received at least one dose of the test investigational medicinal product and had at least one evaluation of the number of detected neoplasiae.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as all enrolled subjects who received at least one dose of the study drug. This population was used for safety evaluation.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled subjects who fulfilled the study protocol requirements in terms of study drug intake and collection of primary efficacy data, without major deviations that could affect study results.

    Primary: Intraepithelial neoplasia detection rate

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    End point title
    		 Intraepithelial neoplasia detection rate
    End point description
    The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with neoplasiae was presented. The number of true positive, true negative, false positive and false negative findings was presented. Sensitivity and specificity of the detection rate of intraepithelial neoplasiae were analysed.
    End point type
    Primary
    End point timeframe
    Day of the colonoscopy
    End point values
    		 Full Analysis Set Per Protocol Population
    Number of subjects analysed
    52
    50
    Units: 52
        At least one intraepithelial neoplasia
    8
    8
        No intraepithelial neoplasia detected
    44
    42
    Statistical analysis title
    		 Number of intraepithelial neoplasiae detected
    Statistical analysis description
    Number of intraepithelial neoplasiae detected by the endoscopist.
    Comparison groups
    Full Analysis Set v Per Protocol Population
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3
    Variability estimate
    Standard deviation
    Dispersion value
    0.5

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day before colonoscopy (day 1), the subjects took investigational product at home with bowel preparation. On the following day (day 2), the patients returned to the clinic for colonoscopy. Patients were assessed for AEs on both days.
    Adverse event reporting additional description
    Safety and tolerability investigations were based on the reporting of adverse events throughout the study, physical examinations and the measurement of vital signs before, during and at the end of the colonoscopy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Nausea
    Reporting group description
    		 8 out of 53 subjects suffered from nausea during the intake of the bowel cleansing preparation. The investigator judged that all 8 reported episodes of nausea were not treatment related AEs. While 6 occurrences of nausea had a mild intensity, the remaining 2 episodes had a moderate intensity. In detail, subjects 9 and 38 suffered from an intermittent nausea of moderate intensity, which prevented them to drink the whole volume of bowel cleansing preparation. Also all other episodes of nausea occurred during the intake of the bowel cleansing preparation and led the affected subjects to interrupt the intake after having drunk 2.5-3.5 L. After interruption of intake of the bowel cleansing preparation, all nausea episodes resolved.

    Reporting group title
    Vomiting
    Reporting group description
    		 1 out of 53 subjects suffered from vomiting during the intake of the bowel cleansing preparation. The investigator judged that this reported episode of gastrointestinal burdens was not a treatment related AE.

    Serious adverse events
    		 Nausea Vomiting
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 1 (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
    		 Nausea Vomiting
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    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: No deaths or serious or other significant adverse events occurred during the study

    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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