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    Clinical Trial Results:
    Colon staining efficacy of single oral doses of methylene blue MMX® modified release tablets administered to patients undergoing colonoscopy

    Summary
    EudraCT number
    		 2011-001173-24
    Trial protocol
    		 IT  
    Global end of trial date
    24 Sep 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-17-01/03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cosmo Technologies Ltd
    Sponsor organisation address
    Riverside II, Dublin, Ireland, D02 KV60
    Public contact
    sduggan@cosmopharma.com, Sarah Duggan, 353 018170370, llongo@cosmopharma.com
    Scientific contact
    llongo@cosmopharma.com, Luigi Longo, 353 018170370, llongo@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
    16 Jan 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe and evaluate the mucosal staining efficacy of methylene blue MMX 25mg modified tablets after single oral doses of 150 or 200mg in patients undergoing a full colonoscopy for various reasons.
    Protection of trial subjects
    Before being admitted to the clinical study, subjects expressed their consent to participate and to the access to their confidential data. The investigator explained the nature, scope and possible consequences of the clinical study in an understandable form. Information was provided to the subjects in both oral and written form. On the day after (day 2), the patients returned to the clinic for colonoscopy. The investigator inquired the subjects about occurrence of any AE and the intake of concomitant medications. Vital signs (BP, HR, SpO2) were measured prior to, during and after the end of the colonoscopy.
    Background therapy
    		 NA
    Evidence for comparator
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3.
    Actual start date of recruitment
    02 May 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
    Italy: 122
    Worldwide total number of subjects
    122
    EEA total number of subjects
    122
    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)
    92
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3.

    Pre-assignment
    Screening details
    		 All subjects received a full dose regimen of a 4-L PEG-based bowel cleansing preparation available on the market, following the instructions enclosed with the product, starting in the afternoon before the colonoscopy day

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MB-MMX-150mg
    Arm description
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3. After protocol amendment 2, additional 50 individual kits from subject number 127 to 176 were packaged with product batch 6324/4 and supplied to the clinical centre. Irrespective of the inclusion date, individual drug supplies of 150 mg were dispensed up to number 025, whereas individual kit of 200 mg were dispensed up to study termination from number 064 to number 160. In conclusion, 24 subjects received 150 mg of methylene blue, whilst 90 subjects received 200 mg of methylene blue (see § 10.1 for details on subjects’ disposition). Individual drug supplies from 026 to 063 and from 161 to 176 remained unused.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylene Blue MMX® modified release tablets
    Investigational medicinal product code
    CB-01-17
    Other name
    LumeBlue
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pharmaceutical form modified release tablets Strength 25 mg Administration route oral Batch N. 6324/3 and 6324/4 Expiry date FEB12

    Arm title
    		 MB-MMX-200mg
    Arm description
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3. After protocol amendment 2, additional 50 individual kits from subject number 127 to 176 were packaged with product batch 6324/4 and supplied to the clinical centre. Irrespective of the inclusion date, individual drug supplies of 150 mg were dispensed up to number 025, whereas individual kit of 200 mg were dispensed up to study termination from number 064 to number 160. In conclusion, 24 subjects received 150 mg of methylene blue, whilst 90 subjects received 200 mg of methylene blue (see § 10.1 for details on subjects’ disposition). Individual drug supplies from 026 to 063 and from 161 to 176 remained unused.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylene Blue MMX® modified release tablets
    Investigational medicinal product code
    CB-01-17
    Other name
    LumeBlue
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pharmaceutical form modified release tablets Strength 25 mg Administration route oral Batch N. 6324/3 and 6324/4 Expiry date FEB12

    Number of subjects in period 1
    		MB-MMX-150mg MB-MMX-200mg
    Started
    25
    97
    Completed
    23
    86
    Not completed
    2
    11
         Consent withdrawn by subject
    1
    7
         Physician decision
    -
    2
         Adverse event, non-fatal
    1
    2

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 122 122
    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)
    		 92 92
        From 65-84 years
    		 30 30
        85 years and over
    		 0 0
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 54.7 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    		 54 54
        Male
    		 68 68

    End points

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    End points reporting groups
    Reporting group title
    MB-MMX-150mg
    Reporting group description
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3. After protocol amendment 2, additional 50 individual kits from subject number 127 to 176 were packaged with product batch 6324/4 and supplied to the clinical centre. Irrespective of the inclusion date, individual drug supplies of 150 mg were dispensed up to number 025, whereas individual kit of 200 mg were dispensed up to study termination from number 064 to number 160. In conclusion, 24 subjects received 150 mg of methylene blue, whilst 90 subjects received 200 mg of methylene blue (see § 10.1 for details on subjects’ disposition). Individual drug supplies from 026 to 063 and from 161 to 176 remained unused.

    Reporting group title
    MB-MMX-200mg
    Reporting group description
    		 Study subjects had to be assigned to either dose of methylene blue in a ratio of 1:1. Therefore, individual doses of 150 mg of Methylene Blue MMX® tablets were initially packaged up to subject number 063 and individual doses of 200 mg were packaged from number 064 to 126 with product batch 6324/3. After protocol amendment 2, additional 50 individual kits from subject number 127 to 176 were packaged with product batch 6324/4 and supplied to the clinical centre. Irrespective of the inclusion date, individual drug supplies of 150 mg were dispensed up to number 025, whereas individual kit of 200 mg were dispensed up to study termination from number 064 to number 160. In conclusion, 24 subjects received 150 mg of methylene blue, whilst 90 subjects received 200 mg of methylene blue (see § 10.1 for details on subjects’ disposition). Individual drug supplies from 026 to 063 and from 161 to 176 remained unused.

    Subject analysis set title
    Analysis of mucosal staining data with 150mg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol population: all enrolled subjects who fulfilled the study protocol requirements in terms of study drug intake and collection of efficacy data, without major deviations that might affect study results.

    Subject analysis set title
    Analysis of mucosal staining data with 200mg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol population: all enrolled subjects who fulfilled the study protocol requirements in terms of study drug intake and collection of efficacy data, without major deviations that might affect study results.

    Primary: Evaluation of the mucosal staining efficacy with MB-MMX 150mg

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    End point title
    		 Evaluation of the mucosal staining efficacy with MB-MMX 150mg [1]
    End point description
    Frequency of staining quality scores (SC) observed in each colonic region in the PP (N=23) and the FAS population (N=24) after 150 mg of Methylene Blue MMX®
    End point type
    Primary
    End point timeframe
    Day of colonoscopy
    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: According to the protocol, the subjects were to be assigned to 150 or 200 mg of methylene blue in a ratio of 1:1. Consecutively treated subjects should have received either dose alternatively. Notwithstanding, subjects’ allocation to either dose had a ratio of 1:3.67 in the FAS population. The dose of 150 mg was received by 24 subjects, whereas the dose of 200 mg was received by 88 subjects in the FAS population (see § 10.1 for details on subjects’ disposition and § 9.4.3 for details of assignme
    End point values
    		 Analysis of mucosal staining data with 150mg
    Number of subjects analysed
    23
    Units: 23
        Score 0
    28
        Score 1
    27
        Score 2
    11
        Score 3
    11
        Score 4
    15
        Score 5
    0
    No statistical analyses for this end point

    Primary: Evaluation of the mucosal staining efficacy with MB-MMX 200mg

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    End point title
    		 Evaluation of the mucosal staining efficacy with MB-MMX 200mg [2]
    End point description
    Frequency of staining quality scores observed in each colonic region in the PP (N=86) and the FAS population (N=88) after 200 mg of Methylene Blue MMX
    End point type
    Primary
    End point timeframe
    Day of colonoscopy
    Notes
    [2] - 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: According to the protocol, the subjects were to be assigned to 150 or 200 mg of methylene blue in a ratio of 1:1. Consecutively treated subjects should have received either dose alternatively. Notwithstanding, subjects’ allocation to either dose had a ratio of 1:3.67 in the FAS population. The dose of 150 mg was received by 24 subjects, whereas the dose of 200 mg was received by 88 subjects in the FAS population (see § 10.1 for details on subjects’ disposition and § 9.4.3 for details of assignme
    End point values
    		 Analysis of mucosal staining data with 200mg
    Number of subjects analysed
    86
    Units: 86
        Score 0
    49
        Score 1
    50
        Score 2
    59
        Score 3
    77
        Score 4
    106
        Score 5
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day of the colonoscopy
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Gastrointestinal
    Reporting group description
    		 -

    Serious adverse events
    		 Gastrointestinal
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 114 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2.6%
    Non-serious adverse events
    		 Gastrointestinal
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 114 (2.63%)
    Gastrointestinal disorders
    Vomiting
    Additional description: vomiting
         subjects affected / exposed
    3 / 114 (2.63%)
         occurrences all number
    1

    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.
    NA
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