Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy of a novel 1l PEG plus ascorbate (Plenvu) bowel preparation vs. 2l PEG plus ascorbate (Moviprep), a randomized controlled multicenter trial (PLEMO)

    Summary
    EudraCT number
    		 2018-003304-39
    Trial protocol
    		 DK  
    Global end of trial date
    10 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2023
    First version publication date
    17 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Digestive disease center, Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen NV, Denmark, 2400
    Public contact
    Morten Rasmussen, Morten Rasmussen, morten.rasmussen@regionh.dk
    Scientific contact
    Morten Rasmussen, Morten Rasmussen, morten.rasmussen@regionh.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
    22 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the bowel cleansing efficacy of either 1L PEG with ascorbate or 2L PEG with ascorbate in a randomized controlled trial including persons participating in the Danish national bowel screening program.
    Protection of trial subjects
    The Danish Data Protection Agency
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 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
    Denmark: 1275
    Worldwide total number of subjects
    1275
    EEA total number of subjects
    1275
    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)
    681
    From 65 to 84 years
    594
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants in the Danish national bowel cancer screening scheduled for colonoscopy at Bispebjerg Hospital will be contacted by a study nurse for the purpose of study recruitment. All participants will be offered the possibility for a consultation with an investigator prior to consenting for participation.

    Pre-assignment
    Screening details
    		 Participants scheduled for a screening colonoscopy at Bispebjerg Hospital Age 50-74 years Possibility for participants to recieve electronic documents Telephone number to participants avalible

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Monitor, Data analyst [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention (1L PEG + Asc)
    Arm description
    		 Participants randomized to recieve intervention (1L polyethylene glycol + ascorbate)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plenvu
    Investigational medicinal product code
    A06A D65
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Powder for Oral Solution consisting of one sachet of Dose 1 and two sachets (A & B) for Dose 2. - Dose 1 taken in the evening before the colonoscopy (approximately 18.00) - Dose 2 taken in the early morning of the day of the colonoscopy. Dose 1: The contents of the sachet for Dose 1 should be dissolved in 500 ml of water. The solution should be taken over a period of 30 minutes, followed by at least 500 ml of clear fluid over the next 30 minutes. Dose 2: The contents of the two sachets (sachets A and B) for Dose 2 should be dissolved with 500 ml of water. The solution should be taken over a period of 30 minutes, followed by at least 500 ml of clear fluid over the next 30 minutes. In addition to the fluids taken as part of the course of treatment, any amount of supplementary clear fluid (e.g. water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk) may be taken.

    Arm title
    		 Control (2L PEG + Asc)
    Arm description
    		 Participants randomized to recieve control (2L polyethylene glycol + ascorbate)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moviprep
    Investigational medicinal product code
    A06A D
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dose 1 + 2: Powder for Oral Solution consisting of one sachet of Dose A and one sachet of Dose B. - Dose 1 taken in the evening before the colonoscopy (approximately 18.00) - Dose 2 taken in the early morning of the day of the colonoscopy. Dose 1 + 2: The contents of sachet A and B should be dissolved in 1 litre of water. The solution should be taken over a period of one to two hours, followed by at least 500 ml of clear fluid In addition to the fluids taken as part of the course of treatment, any amount of supplementary clear fluid (e.g. water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk) may be taken.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This is single-blinded (to investigator). Double blinding was not possible
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This is single-blinded (to investigator). Double blinding was not possible
    Number of subjects in period 1
    		Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Started
    629
    646
    Completed
    615
    628
    Not completed
    14
    18
         Requested colonoscopy at other hospital
    -
    4
         Consent withdrawn by subject
    -
    1
         Physician decision
    -
    1
         Non appearance
    3
    1
         Unknown reasons
    -
    1
         Randomization allocation unclear
    1
    2
         Rejected colonoscopy
    4
    6
         Protocol deviation
    6
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Intervention (1L PEG + Asc)
    Reporting group description
    		 Participants randomized to recieve intervention (1L polyethylene glycol + ascorbate)

    Reporting group title
    Control (2L PEG + Asc)
    Reporting group description
    		 Participants randomized to recieve control (2L polyethylene glycol + ascorbate)

    Reporting group values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc) Total
    Number of subjects
    		 629 646 1275
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 335 346 681
        From 65-84 years
    		 294 300 594
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 64 (56 to 70) 64 (56 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 322 310 632
        Male
    		 307 336 643

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Intervention (1L PEG + Asc)
    Reporting group description
    		 Participants randomized to recieve intervention (1L polyethylene glycol + ascorbate)

    Reporting group title
    Control (2L PEG + Asc)
    Reporting group description
    		 Participants randomized to recieve control (2L polyethylene glycol + ascorbate)

    Primary: To evaluate the overall bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc

    		 Close Top of page
    End point title
    		 To evaluate the overall bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc
    End point description
    Efficacy of the bowel cleansing efficacy in the two arms were determined using the Boston Bowel Preparation Scale. All participants undergoing colonoscopy were assessed.
    End point type
    Primary
    End point timeframe
    After colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    615
    628
    Units: 4
    arithmetic mean (standard deviation)
        BBPS right colon
    2.54 ( 0.77 )
    2.30 ( 0.90 )
        BBPS transverse colon
    2.60 ( 0.71 )
    2.36 ( 0.87 )
        BBPS left colon
    2.63 ( 0.63 )
    2.39 ( 0.80 )
        BBPS total
    7.76 ( 1.93 )
    7.06 ( 2.41 )
    Statistical analysis title
    		 Wilcoxon rank sum test
    Statistical analysis description
    Efficacy will be assessed as bowel cleansing success according to the validated Boston Bowel Preparation Scale (BBPS). Bowel preparation quality will be assessed by the colonoscopist for the following colonic segments: Right colon, transverse colon and left colon. After washing and suctioning have been performed each segment is given a score from 0-3.
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Left colon, transverse colon, right colon and total scores all showed p<0.001

    Primary: To evaluate the bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc in terms of adequate bowel preparation

    		 Close Top of page
    End point title
    		 To evaluate the bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc in terms of adequate bowel preparation
    End point description
    Efficacy of the bowel cleansing efficacy in the two arms were determined using the Boston Bowel Preparation Scale. All participants undergoing colonoscopy were assessed. Data were assessed for all participants with adequate bowel preparation defined as BBPS ≥2 in each segment.
    End point type
    Primary
    End point timeframe
    After colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    567 [2]
    541 [3]
    Units: 4
    arithmetic mean (standard deviation)
        BBPS rigth colon
    2.71 ( 0.45 )
    2.59 ( 0.49 )
        BBPS transverse colon
    2.73 ( 0.45 )
    2.63 ( 0.48 )
        BBPS left colon
    2.71 ( 0.45 )
    2.60 ( 0.49 )
        BBPS total
    8.16 ( 1.23 )
    7.82 ( 1.33 )
    Notes
    [2] - Number of participants with a BBPS score in any segment of at least 2
    [3] - Number of participants with a BBPS score in any segment of at least 2
    Statistical analysis title
    		 Wilcoxon rank sum test
    Statistical analysis description
    Wilcoxon rank sum test
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - Left colon, transverse colon, right colon and total scores all showed p<0.001

    Primary: To evaluate the bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc in terms of excellent bowel preparation

    		 Close Top of page
    End point title
    		 To evaluate the bowel cleansing efficacy of 1L PEG + Asc vs. 2L PEG + Asc in terms of excellent bowel preparation
    End point description
    Efficacy of the bowel cleansing efficacy in the two arms were determined using the Boston Bowel Preparation Scale. All participants undergoing colonoscopy were assessed. Data were assessed for all participants with excellent bowel preparation in each segment (BBPS =3)
    End point type
    Primary
    End point timeframe
    After colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    613
    627
    Units: Number BBPS = 3
        Right colon
    405
    319
        Transverse colon
    420
    345
        Left colon
    421
    336
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants with a BBPS score in any segment of 3
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [5] - Left colon, transverse colon, right colon and overall scores all showed p<0.001

    Secondary: Adenoma detection rate

    		 Close Top of page
    End point title
    		 Adenoma detection rate
    End point description
    Data on adenomas were obtained from histopathologic reports. In case of large lesions planned for subsequent polypectomy or participants on anticoagulation/antiplatelet medication a subsequent colonoscopy was performed and data from these procedures were included as well.
    End point type
    Secondary
    End point timeframe
    During colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    615
    628
    Units: %
        Adenoma detection rate
    50
    48
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants where at least one adenoma was detected
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Cancer detection

    		 Close Top of page
    End point title
    		 Cancer detection
    End point description
    Data on adenomas were obtained from histopathologic reports. In case of large lesions planned for subsequent polypectomy or participants on anticoagulation/antiplatelet medication a subsequent colonoscopy was performed and data from these procedures were included as well.
    End point type
    Secondary
    End point timeframe
    During colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    615
    628
    Units: number
        Number of cancers
    27
    24
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants detected with colorectal cancer
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Serrated lesion detection rate

    		 Close Top of page
    End point title
    		 Serrated lesion detection rate
    End point description
    Data on adenomas were obtained from histopathologic reports. In case of large lesions planned for subsequent polypectomy or participants on anticoagulation/antiplatelet medication a subsequent colonoscopy was performed and data from these procedures were included as well.
    End point type
    Secondary
    End point timeframe
    During colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    615
    628
    Units: %
        Serrated lesion detection rate (%)
    16
    15
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Rate of participants with at least one serrated lesion detected
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, nausea

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, nausea
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Nausea
    344
    288
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants reporting any nausea
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, vomit

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, vomit
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Vomit
    83
    54
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants reporting of any comiting
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, bloating

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, bloating
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Bloating
    382
    420
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants reporting of any bloating
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, headache

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, headache
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Headache
    214
    188
    Statistical analysis title
    		 Chi square
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.057
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, sleep interrupted

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, sleep interrupted
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Sleep interrupted
    358
    376
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants reporting any disturbance of sleep
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Tolerability of the bowel preparation, willingness to repeat

    		 Close Top of page
    End point title
    		 Tolerability of the bowel preparation, willingness to repeat
    End point description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy
    End point type
    Secondary
    End point timeframe
    Prior to colonoscopy
    End point values
    		 Intervention (1L PEG + Asc) Control (2L PEG + Asc)
    Number of subjects analysed
    599
    618
    Units: Condition present, %
        Willingness to repeat
    492
    469
    Statistical analysis title
    		 Chi square
    Statistical analysis description
    Number of participants reporting willingness to repeat the bowel cleansing
    Comparison groups
    Intervention (1L PEG + Asc) v Control (2L PEG + Asc)
    Number of subjects included in analysis
    1217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day and time of colonoscopy for participants reported events 30 day follow up for complications
    Adverse event reporting additional description
    Participants were asked to answer a questionnaire when arriving at the endoscopy unit, but prior to colonoscopy. This questionnaire included information about any adverse events/side effects other than asked in the questionnaire (nausea, vomit, bloating, headache and disturbance of sleep). A file look-up was made to evaluate 30 day complications.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    unknown
    Reporting groups
    Reporting group title
    1L PEG + Asc
    Reporting group description
    		 -

    Reporting group title
    2L PEG + Asc
    Reporting group description
    		 -

    Serious adverse events
    		 1L PEG + Asc 2L PEG + Asc
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 615 (0.00%)
    0 / 628 (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: 0.1%
    Non-serious adverse events
    		 1L PEG + Asc 2L PEG + Asc
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 615 (12.20%)
    56 / 628 (8.92%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 615 (1.14%)
    4 / 628 (0.64%)
         occurrences all number
    7
    4
    Fatigue
         subjects affected / exposed
    5 / 615 (0.81%)
    3 / 628 (0.48%)
         occurrences all number
    5
    3
    Headache
         subjects affected / exposed
    0 / 615 (0.00%)
    2 / 628 (0.32%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Freezing
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Non function
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Unrest
         subjects affected / exposed
    2 / 615 (0.33%)
    3 / 628 (0.48%)
         occurrences all number
    2
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 615 (0.33%)
    18 / 628 (2.87%)
         occurrences all number
    2
    18
    Bloating
         subjects affected / exposed
    4 / 615 (0.65%)
    6 / 628 (0.96%)
         occurrences all number
    4
    6
    Constipation
         subjects affected / exposed
    0 / 615 (0.00%)
    1 / 628 (0.16%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 615 (0.33%)
    0 / 628 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Fecal incontinence
         subjects affected / exposed
    2 / 615 (0.33%)
    1 / 628 (0.16%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    3 / 615 (0.49%)
    1 / 628 (0.16%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Flu
         subjects affected / exposed
    3 / 615 (0.49%)
    0 / 628 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Anal discomfort
         subjects affected / exposed
    14 / 615 (2.28%)
    5 / 628 (0.80%)
         occurrences all number
    14
    5
    Rash
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 615 (0.16%)
    0 / 628 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Fever
         subjects affected / exposed
    1 / 615 (0.16%)
    1 / 628 (0.16%)
         occurrences all number
    1
    1
    Freezing
         subjects affected / exposed
    11 / 615 (1.79%)
    9 / 628 (1.43%)
         occurrences all number
    11
    9
    Metabolism and nutrition disorders
    Poor palatability
         subjects affected / exposed
    2 / 615 (0.33%)
    2 / 628 (0.32%)
         occurrences all number
    2
    2
    Thirst
         subjects affected / exposed
    11 / 615 (1.79%)
    0 / 628 (0.00%)
         occurrences all number
    11
    0

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-Sat May 18 21:22:45 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA