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    Clinical Trial Results:
    Efficacy, Safety and Tolerability of CitraFleet, a New Bowel Cleansing Agent – a Prospective, Single-Center, Single-Group Phase IV Study

    Summary
    EudraCT number
    		 2018-003257-16
    Trial protocol
    		 HU  
    Global end of trial date
    17 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2021
    First version publication date
    03 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CitraFleet_H-2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goodwill Pharma Kft
    Sponsor organisation address
    Cserzy Mihály u. 32., Szeged, Hungary, 6724
    Public contact
    DQPPV, Goodwill Pharma Kft, 36 704522104, janoska.zsolt@goodwillpharma.com
    Scientific contact
    DQPPV, Goodwill Pharma Kft, 36 704522104, janoska.zsolt@goodwillpharma.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
    17 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To measure efficacy of CitraFleet by using Boston Bowel Preparation Scale.
    Protection of trial subjects
    The Investigators will ensure that the patient is given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Patients must also be notified that they are free to discontinue from the study at any time. The patient should be given the opportunity to ask questions and allowed time to consider the information provided. The patient’s signed and dated informed consent must be obtained before conducting any procedure specifically for the study.
    Background therapy
    		 Patients scheduled to undergo colonoscopy
    Evidence for comparator
    		 NA single group study
    Actual start date of recruitment
    15 Jan 2019
    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
    Hungary: 93
    Worldwide total number of subjects
    93
    EEA total number of subjects
    93
    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)
    73
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on 25th March 2019 and last patient last visit took place on 31st October 2019. Patients were enrolled at a signle study site (Colonscopy Unit, Department of Internal Medicine No. I., University of Szeged)

    Pre-assignment
    Screening details
    		 A total of 100 patients were screened, 93 were treated and enrolled to the study.

    Period 1
    Period 1 title
    Colonoscopy
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA no blinding

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients treated
    Arm type
    		 Experimental

    Investigational medicinal product name
    CitraFleet por belsőleges oldathoz
    Investigational medicinal product code
    A06AB58
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    30 g administered according to approved Summary of Product Characteristics.

    Number of subjects in period 1
    		All patients
    Started
    93
    Completed
    93
    Period 2
    Period 2 title
    Screening
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients treated
    Arm type
    		 Experimental

    Investigational medicinal product name
    CitraFleet por belsőleges oldathoz
    Investigational medicinal product code
    A06AB58
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    30 g administered according to approved Summary of Product Characteristics.

    Number of subjects in period 2
    		All patients
    Started
    93
    Completed
    93

    Baseline characteristics

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

    Reporting group values
    		 Colonoscopy Total
    Number of subjects
    		 93 93
    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)
    		 73 73
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 51 51
        Male
    		 42 42

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients treated
    Reporting group title
    All patients
    Reporting group description
    		 All patients treated

    Primary: Boston Bowel Preparation Scale

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    End point title
    		 Boston Bowel Preparation Scale [1]
    End point description
    The efficacy of Citrafleet will be measured using the Boston Bowel Preparation Scale by the ratio of patients achieving appropriate cleaning. An overall score of 6-9, with a score of at least 2 in each colon segment will be considered appropriate cleaning, a score of 0-5, or any segmential score below 2 means that the preparation method was unsatisfactory.
    End point type
    Primary
    End point timeframe
    Assessed by the Investigator during endoscopy procedure.
    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: No formal hypothesis testiing
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        ratio of atients with appropriate cleaning
    85
        incomplete examination
    5
        ineffective bowel preparation
    3
    No statistical analyses for this end point

    Secondary: Safety by serum Na values

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    End point title
    		 Safety by serum Na values
    End point description
    For each laboratory parameter number and frequency of the above categories will be given by timepoint (i.e. at screening and at colonoscopy).
    End point type
    Secondary
    End point timeframe
    For each laboratory parameter number and frequency of the above categories will be given by timepoint (i.e. at screening and at colonoscopy).
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: patients
        normal
    92
    91
        abnormal, not sigificant
    1
    2
        abnormal significant
    0
    0
    No statistical analyses for this end point

    Secondary: Safety by serum K values

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    End point title
    		 Safety by serum K values
    End point description
    Laboratory parameters will be categorized as  normal,  abnormal, clinically not significant,  abnormal, clinically significant.
    End point type
    Secondary
    End point timeframe
    For each laboratory parameter number and frequency of the above categories will be given by timepoint (i.e. at screening and at colonoscopy).
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: patients
        normal
    89
    87
        abnormal, clinically not significant,
    4
    6
         abnormal, clinically significant.
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Na values descriptive statistics

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    End point title
    		 Serum Na values descriptive statistics
    End point description
    The change in continuous laboratory parameter values will be analyzed using descriptive statistics (mean, standard deviation, median, minimum and maximum).
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: mmol/l
        arithmetic mean (standard deviation)
    140.53 ± 1.96
    139 ± 1.96
    No statistical analyses for this end point

    Secondary: Serum K values descriptive statistics

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    End point title
    		 Serum K values descriptive statistics
    End point description
    The change in continuous laboratory parameter values will be analyzed using descriptive statistics (mean, standard deviation, median, minimum and maximum)
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: mmol/l
        arithmetic mean (standard deviation)
    4.43 ± 0.38
    4.29 ± 0.36
    No statistical analyses for this end point

    Secondary: Serum urea categorical

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    End point title
    		 Serum urea categorical
    End point description
    Laboratory parameters will be categorized as  normal,  abnormal, clinically not significant,  abnormal, clinically significant.
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: patients
        normal
    89
    87
        abnormal, clinically not significant,
    4
    6
        abnormal, clinically significant
    0
    0
    No statistical analyses for this end point

    Secondary: Serum urea descriptive

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    End point title
    		 Serum urea descriptive
    End point description
    The change in continuous laboratory parameter values will be analyzed using descriptive statistics (mean, standard deviation, median, minimum and maximum).
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: mmol/l
        arithmetic mean (standard deviation)
    4.60 ± 1.36
    3.30 ± 1.07
    No statistical analyses for this end point

    Secondary: Serum creatinine categorical

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    End point title
    		 Serum creatinine categorical
    End point description
    Laboratory parameters will be categorized as  normal,  abnormal, clinically not significant,  abnormal, clinically significant.
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: patients
        normal
    87
    87
        abnormal, clinically not significant,
    6
    6
        abnormal, clinically significant
    0
    0
    No statistical analyses for this end point

    Secondary: Serum creatinine descriptive

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    End point title
    		 Serum creatinine descriptive
    End point description
    The change in continuous laboratory parameter values will be analyzed using descriptive statistics (mean, standard deviation, median, minimum and maximum).
    End point type
    Secondary
    End point timeframe
    screening and at colonoscopy
    End point values
    		 All patients All patients
    Number of subjects analysed
    93
    93
    Units: mmol/l
        arithmetic mean (standard deviation)
    73.64 ± 14.22
    76.41 ± 13.92
    No statistical analyses for this end point

    Secondary: Overall tolerability (VAS scale)

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    End point title
    		 Overall tolerability (VAS scale)
    End point description
    The overall tolerability (based on the VAS scale) will be described bythe mean, median, minimum and maximum values.
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: NA
        arithmetic mean (full range (min-max))
    8.48 (1 to 10)
    No statistical analyses for this end point

    Secondary: Patient opinion on taste

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    End point title
    		 Patient opinion on taste
    End point description
    Patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    83
        medium symptoms
    3
        severe symptoms
    7
    No statistical analyses for this end point

    Secondary: Patient opinion on excessive thirst

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    End point title
    		 Patient opinion on excessive thirst
    End point description
    Via patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    After colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    90
        medium symptoms
    3
        severe symptoms
    0
    No statistical analyses for this end point

    Secondary: Patient opinion on nausea

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    End point title
    		 Patient opinion on nausea
    End point description
    via patient tolerabilty questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    88
        medium symptoms
    4
        severe symptoms
    1
    No statistical analyses for this end point

    Secondary: Patient feedback on bloating

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    End point title
    		 Patient feedback on bloating
    End point description
    via tolerability questionaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    87
        medium symptoms
    6
        severe symptoms
    0
    No statistical analyses for this end point

    Secondary: Patient feedback on abdominal pain and cramps

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    End point title
    		 Patient feedback on abdominal pain and cramps
    End point description
    via patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    83
        medium symptoms
    10
        severe symptoms
    0
    No statistical analyses for this end point

    Secondary: Patient feedback on headache

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    End point title
    		 Patient feedback on headache
    End point description
    via patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    89
        medium symptoms
    4
        severe symptoms
    0
    No statistical analyses for this end point

    Secondary: Patient feedback on dizziness

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    End point title
    		 Patient feedback on dizziness
    End point description
    via patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    91
        medium symptoms
    1
        severe symptoms
    1
    No statistical analyses for this end point

    Secondary: Patient feedback on sleep disturbance

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    End point title
    		 Patient feedback on sleep disturbance
    End point description
    via patient tolerability questionnaire
    End point type
    Secondary
    End point timeframe
    after colonoscopy
    End point values
    		 All patients
    Number of subjects analysed
    93
    Units: patients
        normal
    91
        medium symptoms
    2
        severe symptoms
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from screening until end of colonoscopy procedure (end-of-study).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 Safety population consists of all patients who were involved in the study and received the study medication.

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 93 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 93 (72.04%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 93 (18.28%)
         occurrences all number
    17
    Dizziness
         subjects affected / exposed
    16 / 93 (17.20%)
         occurrences all number
    16
    Sleep disorder
         subjects affected / exposed
    20 / 93 (21.51%)
         occurrences all number
    20
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    30 / 93 (32.26%)
         occurrences all number
    30
    Abdominal pain
         subjects affected / exposed
    36 / 93 (38.71%)
         occurrences all number
    36
    Metabolism and nutrition disorders
    Thirst
         subjects affected / exposed
    29 / 93 (31.18%)
         occurrences all number
    29
    Nausea
         subjects affected / exposed
    23 / 93 (24.73%)
         occurrences all number
    23

    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
    For support, Contact us.
    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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