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    Clinical Trial Results:
    Optimizing Colon Capsule Endoscopy in follow up program on patients with colorectal polyps assessing three booster procedures for motility enhancement

    Summary
    EudraCT number
    		 2016-002237-30
    Trial protocol
    		 DK  
    Global end of trial date
    01 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jan 2021
    First version publication date
    27 Jan 2021
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    CAREforCOLONbooster
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Baagøes Alle, Svendborg, Denmark,
    Public contact
    Research Unit,Department of Surgery, OUH Odense University Hospital, Svendborg Sygehus, akd@rsyd.dk
    Scientific contact
    Research Unit,Department of Surgery, OUH Odense University Hospital, Svendborg Sygehus, akd@rsyd.dk
    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
    07 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE.
    Protection of trial subjects
    Exclusion criteria were previous bowel surgery except appendectomy, renal insufficiency, pacemaker, pregnancy, breastfeeding, inflammatory bowel disease or allergies towards active substances administered in the trial. All participants who commenced bowel preparation were included in the analyses as intention to treat. All participants signed informed written consent.
    Background therapy
    		 All participants received a bowel preparation consisting of magnesium tablets, 2-L split-dose PEG solution (Moviprep, Norgine, Denmark) and were kept on a diet of watery fluids.
    Evidence for comparator
    		 We designed a three arm randomized trial to assess three different booster regimen´s effect on excretion. Moviprep, Eziclen and moviprep with gastrografin has previously been reported as well tolerated, low risk and effective.
    Actual start date of recruitment
    01 Feb 2017
    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
    Denmark: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    109
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled for follow-up colonoscopy at Odense University Hospital and Hospital of Southwest Jutland between February 1st, 2017 and November 1st, 2017 were screened. Inclusion criteria were follow-up due to previous neoplastic findings or familial history of colorectal cancer and age 18 to 70 years.Exclusion criteria were previous bowe

    Pre-assignment
    Screening details
    		 A total of 1707 patients were screened for eligibility and 517 invitations were sent. We included 180 eligible consecutive patients that responded and fulfilled the criteria. We included 140 (78%) participants at center one, and 40 (22%) participants at center two

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moviprep
    Arm description
    		 Moviprep booster
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moviprep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Booster regimen Signal 1 (Capsule reached the small bowel) 0.75 L Moviprep® solution 0.75 L water Signal 2 (3 hours after signal 1) 0.25 L Moviprep® solution 0.25 L water Signal 3 (2 hours after signal 2) 10 mg Rectal Bisacodyl 1 hour after Signal 3: No dietary restrictions

    Arm title
    		 Eziclen
    Arm description
    		 Eziclen Booster
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eziclen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Booster regimen Signal 1 (Capsule reached the small bowel) 0.25 L Eziclen® solution 0.75 L water Signal 2 (3 hours after signal 1) 0.25 L Eziclen® solution 0.75 L water Signal 3 (2 hours after signal 2) Group A Group B Group C 10 mg Rectal Bisacodyl 1 hour after Signal 3: No dietary restrictions

    Arm title
    		 Moviprep + Gastrografin
    Arm description
    		 Moviprep + Gastrografin booster
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moviprep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Booster regimen Signal 1 (Capsule reached the small bowel) 0.75 L Moviprep® solution 0.75 L water Signal 2 (3 hours after signal 1) 0.25 L Moviprep® solution 0.25 L water Signal 3 (2 hours after signal 2) 10 mg Rectal Bisacodyl 1 hour after Signal 3: No dietary restrictions

    Investigational medicinal product name
    Gastrografin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Booster regimen Signal 1 (Capsule reached the small bowel) 50 mL Gastrografin® Signal 2 (3 hours after signal 1) 25 mL Gastrografin® Signal 3 (2 hours after signal 2) 10 mg Rectal Bisacodyl 1 hour after Signal 3: No dietary restrictions

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Included individuals and nurses delivering the investigations were not blinded. But arm randomization was blinded to assessors, investigator and data analyst.
    Number of subjects in period 1
    		Moviprep Eziclen Moviprep + Gastrografin
    Started
    60
    60
    60
    Completed
    54
    57
    57
    Not completed
    6
    3
    3
         Adverse event, non-fatal
    6
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moviprep
    Reporting group description
    		 Moviprep booster

    Reporting group title
    Eziclen
    Reporting group description
    		 Eziclen Booster

    Reporting group title
    Moviprep + Gastrografin
    Reporting group description
    		 Moviprep + Gastrografin booster

    Reporting group values
    		 Moviprep Eziclen Moviprep + Gastrografin Total
    Number of subjects
    		 60 60 60 180
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 59 (34 to 70) 58 (38 to 70) 58 (32 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 32 25 30 87
        Male
    		 28 35 30 93

    End points

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    End points reporting groups
    Reporting group title
    Moviprep
    Reporting group description
    		 Moviprep booster

    Reporting group title
    Eziclen
    Reporting group description
    		 Eziclen Booster

    Reporting group title
    Moviprep + Gastrografin
    Reporting group description
    		 Moviprep + Gastrografin booster

    Primary: Capsule exretion

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    End point title
    		 Capsule exretion
    End point description
    Timely anal excretion of the capsule while recording
    End point type
    Primary
    End point timeframe
    At investigation
    End point values
    		 Moviprep Eziclen Moviprep + Gastrografin
    Number of subjects analysed
    60
    60
    60
    Units: Individuals
        Excreted
    42
    44
    41
        Not excreted
    18
    16
    19
    Statistical analysis title
    		 confidence interval
    Comparison groups
    Moviprep v Eziclen v Moviprep + Gastrografin
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - 95% Confidence intervals was reported for each group

    Secondary: Adequate bowel preparation

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    End point title
    		 Adequate bowel preparation
    End point description
    Bowel cleanliness was graded according to the validated Leighton-Rex scale from 1-4 (1: Poor, 2: Fair, 3: Good, 4: Excellent)[30]. Bowel cleansing grade 2-4 was regarded as adequate for clinical purposes. An investigation with no images of the colon due to slow transit was regarded as bowel cleansing grade 1. A video with images of the anal verge was regarded as excreted.
    End point type
    Secondary
    End point timeframe
    At video investigation
    End point values
    		 Moviprep Eziclen Moviprep + Gastrografin
    Number of subjects analysed
    60
    60
    60
    Units: Individuals
        Adequate
    47
    57
    53
        Inadequate
    13
    3
    7
    No statistical analyses for this end point

    Secondary: Complete examination

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    End point title
    		 Complete examination
    End point description
    In order to obtain a complete examination the individual should have a timely capsule excretion and an adequate bowel preparation
    End point type
    Secondary
    End point timeframe
    Composite endpoint
    End point values
    		 Moviprep Eziclen Moviprep + Gastrografin
    Number of subjects analysed
    60
    60
    60
    Units: Individuals
        Complete
    39
    43
    37
        Incomplete
    21
    17
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Trial start and untill 2 days after capsule excretion.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2
    Reporting groups
    Reporting group title
    Moviprep
    Reporting group description
    		 Moviprep booster

    Reporting group title
    Eziclen
    Reporting group description
    		 Eziclen Booster

    Reporting group title
    Moviprep + Gastrografin
    Reporting group description
    		 Moviprep + Gastrografin booster

    Serious adverse events
    		 Moviprep Eziclen Moviprep + Gastrografin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Moviprep Eziclen Moviprep + Gastrografin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 60 (10.00%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    6 / 60 (10.00%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
         occurrences all number
    6
    3
    3

    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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