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    Clinical Trial Results:
    Mode of action of Moviprep:impact on distribution of intestinal fluid and colonic microbiota

    Summary
    EudraCT number
    2010-021879-85
    Trial protocol
    GB  
    Global end of trial date
    17 Apr 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2019
    First version publication date
    05 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    10050
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Jubilee Campus Wollaton Road , Nottingham , United Kingdom, NG8 1BB
    Public contact
    Professor Robin Spiller Nottingham Digestive Diseases Biomedical Research Unit Nottingham Digestiv, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
    Scientific contact
    Professor Robin Spiller Nottingham Digestive Diseases Biomedical Research Unit Nottingham Digestiv, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Jubilee Campus Wollaton Road , Nottingham , United Kingdom, NG8 1BB
    Public contact
    Emma Bradley, Nottingham Digestive Diseases Biomedical Research Unit, 0115 823090, emma.bradley@nottingham.ac.uk
    Scientific contact
    Professor Robin Spiller, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
    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 Apr 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patients often have to take osmotic laxatives to prepare the colon for colonoscopy or barium enema. We are interested in how these work and whether taking the dose all at once or in divided doses will affect the water distribution in the small bowel.
    Protection of trial subjects
    The National Research Ethics Service (NREC) ethics approval (version 2.0 dated 20th August 2010), approval number 10/H0906/50, was obtained on 29th August 2010.
    Background therapy
    none all healthy volunteers
    Evidence for comparator
    Comparator was same preparation given in divided or single dose
    Actual start date of recruitment
    08 Sep 2010
    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
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    by public advert

    Pre-assignment
    Screening details
    Bowel symptom questionnaire to exclude functional bowel disorders

    Pre-assignment period milestones
    Number of subjects started
    24
    Number of subjects completed
    24

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Study compared 2l with 1l in divided doses given on two consecutive days

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group1
    Arm description
    Consumed 1l litre moviprep at 1300h on day 1 and repeated on day 2
    Arm type
    Active comparator

    Investigational medicinal product name
    Moviprep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1litre made by adding sachet A and B together in 1 litre of tap water Sachet A contains the following active substances: Macrogol 3350 Sodium sulfate anhydrous Sodium chloride Potassium chloride 100 g 7.500 g 2.691 g 1.015 g Sachet B contains the following active substances: Ascorbic acid Sodium ascorbate 4.700 g 5.900 g The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows: Sodium Sulfate Chloride Potassium Ascorbate 181.6 mmol/L (of which not more than 56.2 mmol is absorbable) 52.8 mmol/L 59.8 mmol/L 14.2 mmol/L 29.8 mmol/L

    Arm title
    group 2
    Arm description
    2l moviprep
    Arm type
    Active comparator

    Investigational medicinal product name
    Moviprep
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2litre made by adding 2sachet A and 2B together in 2 litre of tap water Sachet A contains the following active substances: Macrogol 3350 Sodium sulfate anhydrous Sodium chloride Potassium chloride 100 g 7.500 g 2.691 g 1.015 g Sachet B contains the following active substances: Ascorbic acid Sodium ascorbate 4.700 g 5.900 g The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows: Sodium Sulfate Chloride Potassium Ascorbate 181.6 mmol/L (of which not more than 56.2 mmol is absorbable) 52.8 mmol/L 59.8 mmol/L 14.2 mmol/L 29.8 mmol/L

    Number of subjects in period 1
    Group1 group 2
    Started
    12
    12
    Completed
    11
    12
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group1
    Reporting group description
    Consumed 1l litre moviprep at 1300h on day 1 and repeated on day 2

    Reporting group title
    group 2
    Reporting group description
    2l moviprep

    Subject analysis set title
    all
    Subject analysis set type
    Per protocol
    Subject analysis set description
    all completing study

    Primary: small bowel water content

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    End point title
    small bowel water content
    End point description
    AUC o-4 hours after ingestion
    End point type
    Primary
    End point timeframe
    0-4hours after ingestion
    End point values
    Group1 group 2 all
    Number of subjects analysed
    12 [1]
    12
    23
    Units: AUC ml.min
        number (not applicable)
    1925
    1653
    1789
    Notes
    [1] - i failed to complete study
    Statistical analysis title
    statistics
    Statistical analysis description
    ANOVA
    Comparison groups
    Group1 v group 2
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.05
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    272
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    612
    Variability estimate
    Standard deviation
    Dispersion value
    170
    Notes
    [2] - ANOVA for effect of time and treatment

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    study days
    Adverse event reporting additional description
    mild abdominal discomfort after moviprep ingestion
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    group1
    Reporting group description
    -

    Reporting group title
    group2
    Reporting group description
    -

    Serious adverse events
    group1 group2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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
    group1 group2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    4 / 12 (33.33%)
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 12 (25.00%)
    4 / 12 (33.33%)
         occurrences all number
    3
    4

    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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