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    Clinical Trial Results:
    Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).

    Summary
    EudraCT number
    2010-018340-14
    Trial protocol
    GB  
    Global end of trial date
    30 May 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions
    Summary report(s)
    MIBS Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    10085
    Additional study identifiers
    ISRCTN number
    ISRCTN76612274
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Lenton Lane, Nottingham, United Kingdom, NG7 2NR
    Public contact
    Robin Spiller, University of Nottingham, robin.spiller@nottingham.ac.uk
    Scientific contact
    Robin Spiller, University of Nottingham, 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
    30 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of mesalazine on stool frequency.
    Protection of trial subjects
    n/a
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Feb 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
    United Kingdom: 136
    Worldwide total number of subjects
    136
    EEA total number of subjects
    136
    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)
    136
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants will be recruited from IBS clinics at the investigator’s hospital, or from lists of patients who have previously taken part in research studies and have indicated that they would like to be contacted about future relevant research projects. In addition, we will, in conjunction with the local Primary Care Research Network, approach GPs

    Pre-assignment
    Screening details
    Male or Female patients aged 18-75 years able to give informed consent. Patients should all have had a colonoscopy or sigmoidoscopy within the last 12 months to exclude microscopic or any inflammatory colitis. (If not, but they have had a negative colonoscopy within 5 years and symptoms are unchanged, then a sigmoidoscopy and mucosal biopsy

    Pre-assignment period milestones
    Number of subjects started
    136
    Number of subjects completed
    136

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    This is a double blind parallel study. Neither participant nor supervising doctor nor study nurse will be aware of the treatment allocation. The randomisation will be based on a computer generated pseudo-random code using random permuted blocks of randomly varying size, created by the Nottingham Clinical Trials Unit (CTU) in accordance with their standard operating procedure (SOP) and held on a secure server. The randomisation will be stratified by the recruiting centre.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Experimental: Mesalazine Granules
    Arm description
    2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Mesalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

    Investigational medicinal product name
    Mesalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

    Arm title
    Placebo Comparator: Placebo Granules
    Arm description
    Placebo Comparator: Placebo Granules 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

    Number of subjects in period 1
    Experimental: Mesalazine Granules Placebo Comparator: Placebo Granules
    Started
    68
    68
    Completed
    68
    68

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Experimental: Mesalazine Granules
    Reporting group description
    2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

    Reporting group title
    Placebo Comparator: Placebo Granules
    Reporting group description
    Placebo Comparator: Placebo Granules 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

    Primary: Average stool frequency during weeks 11-12 of the treatment period.

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    End point title
    Average stool frequency during weeks 11-12 of the treatment period.
    End point description
    End point type
    Primary
    End point timeframe
    End of Study
    End point values
    Experimental: Mesalazine Granules Placebo Comparator: Placebo Granules
    Number of subjects analysed
    68
    68
    Units: Whole Numbers
    68
    68
    Statistical analysis title
    Stats Analysis
    Statistical analysis description
    For descriptive purposes continuous data will be summarised in terms of the mean, standard deviation, median, lower & upper quartiles, minimum, maximum and number of observations. Categorical data will be summarised in terms of frequency counts and percentages. Statistical modelling will be used to evaluate the primary and secondary outcomes, and safety data.
    Comparison groups
    Experimental: Mesalazine Granules v Placebo Comparator: Placebo Granules
    Number of subjects included in analysis
    136
    Analysis specification
    Post-hoc
    Analysis type
    equivalence
    P-value
    < 0.05
    Method
    Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In accordance with the Clinical Trials Statutory Instrument 2004 No. 1031
    Adverse event reporting additional description
    Reference Safety Information: MEDRA coding dictionary used. Expectedness definitions taken from UK regulations.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Unrelated
    Reporting group description
    Unrelated to IMP

    Reporting group title
    Possibly related
    Reporting group description
    Serious adverse reaction which possibly may be related to IMP

    Serious adverse events
    Unrelated Possibly related
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 136 (0.74%)
    1 / 136 (0.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Chest Pain
    Additional description: Had ruled out cardiac event and pulmonary embolism Treated for chest infection. Symptoms improved. Trial medication stopped with no long term sequalae.
         subjects affected / exposed
    0 / 136 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Unrelated Possibly related
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 136 (2.21%)
    0 / 136 (0.00%)
    Cardiac disorders
    Loss of consciousness
    Additional description: Fainting spell after a planned arthroscopy. Hospitalised for observation and discharged after 24 hours.
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 136 (0.00%)
         occurrences all number
    0
    0
    Reproductive system and breast disorders
    Breast cancer
    Additional description: Newly diagnosed with breast cancer and treatment was on going from the date of diagnosis Withdrew from trial as the outcome from this diagnosis may interfere with the trial results
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Anal bleeding
    Additional description: Anal pain and small PR bleeding post colonoscopy
         subjects affected / exposed
    1 / 136 (0.74%)
    0 / 136 (0.00%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2010
    1) Protocol (version 2.0, 25 Nov 2010) a) We have altered inclusion criteria 2 to include any inflammatory colitis, not just microscopic colitis. b) Addition of faecal tryptases as a mechanistic secondary endpoint. The analysis of faecal tryptases was already mentioned in the objectives, but omitted by mistake from the endpoints. Addition of a new secondary endpoint detailing polymorphic DNA analysis of participants with details about sampling and storage of the DNA also added. c) Change of manufacturer from MIA(IMP)19162 to MIA(IMP)17136. This involves the labelling and final assembly of blinding supplies. Several references to the license holder have been amended. d) Expand abbreviation (NUH – Nottingham University Hospitals NHS Trust) e) Addition of details of the Rome III questionnaire and the post-infectious IBS-D questionnaire. 2) Daily Symptom and Stool Diary (version 2.0, 25 Nov 2010) We have altered the layout of this document and changed the scale from which the participants must score their symptoms. We have not detailed the changes below but instead submitted the whole document for review. 3) Post-Infectious IBS-D Criteria Participants will complete 4 questions to help sub-type them with or without post-infectious IBS-D. This is a new document so we have not detailed the changes below but instead submitted the new document in whole. 4) Patient information sheet (version 2.0, 25 Nov 2010) Details regarding the collection, analysis and future use of a DNA sample have been added. 5) Consent Form (version 2.0, 25 Nov 2010) Optional consent for a DNA sample to be collected, analysed and store for future use has been added. Reference to the new version of the PIS has changed 7) Simplified IMP-D (version 1.1, 25 Nov 2010) We have changed the contact details for one of the manufacturer’s. The previous were unable to fulfil their commitment. (We have also submitted, to the CA only, a copy of the new manufacturer’s license.) 8) Initial
    05 May 2011
    Altered inclusion criteria 2 to include colonoscopy or sigmoidoscopy, not just colonoscopy. b) Altered inclusion criteria 5 whereby patients with stool frequency of 3 or more per day for 2 or more days per week during the screening phase are eligible to be included into the study. Previously, part of eligibility into the study was patient with average stool frequency of 3 or more per day during the screening phase.

    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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