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    Clinical Trial Results:
    Ondansetron for the treatment of IBS with diarrhoea (IBS-D): Identifying the “responder”

    Summary
    EudraCT number
    		 2008-000623-25
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jun 2011

    Results information
    Results version number
    		 v1
    This version publication date
    07 Jan 2019
    First version publication date
    07 Jan 2019
    Other versions
    		 v2
    Summary report(s)
    		 published paper

    Trial information

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    Trial identification
    Sponsor protocol code
    32492
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00745004
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nottingham University Hospitals NHS Trust
    Sponsor organisation address
    Queen's Medical Centre, Clifton Boulevard, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Professor Robin Spiller, Nottingham University Hospitals NHS Trust, 0115 8231032, robin.spiller@nottingham.ac.uk
    Scientific contact
    Professor Robin Spiller, Nottingham University Hospitals NHS Trust, 0115 8231032, robin.spiller@nottingham.ac.uk
    Sponsor organisation name
    Nottingham University Hospitals NHS Trust
    Sponsor organisation address
    Queen's Medical Centre, Clifton Boulevard, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Professor Robin Spiller, Nottingham Digestive Diseases Biomedical Research Unit Nottingham Digestive Diseases Centre Unive, 0115 823090, emma.bradley@nottingham.ac.uk
    Scientific contact
    Professor Robin Spiller, Nottingham Digestive Diseases Biomedical Research Unit Nottingham Digestive Diseases Centre Unive, 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
    30 Jun 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify clinical features which will predict response to Ondansetron in clinical practice in patients with IBS symptoms with diarrhoea. using a cross-over design
    Protection of trial subjects
    The trial was registered on clinicaltrials.gov (identifier NCT00745004), approved by Nottingham Research Ethics Committee 2 (REC reference number 08/H0408/134) and by the Medicines and Healthcare Regulatory authority (MHRA, London, UK), and conducted according to Good Clinical Practice guidelines.
    Background therapy
    		 none
    Evidence for comparator
    		 placebo was used as no approved therapy for IBS with diarrhoea
    Actual start date of recruitment
    01 Jan 2009
    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: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Clinics and public advertisement

    Pre-assignment
    Screening details
    		 Screened to exclude coeliac disease, microscopic colitis

    Period 1
    Period 1 title
    first treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    overencapsulated identical appearing capsules or ondansetron 4mg

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo
    Arm description
    		 placebo tablets titrated from 1 daily or every other day up to 2 t.d.s
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    inert filler

    Arm title
    		 ondansetron
    Arm description
    		 ondansetron 4mg tablets titrated from 1 daily or every other day up to 2 t.d.s
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ondansetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ondansetron 4mg tablets titrated from 1 daily or every other day up to 2 t.d.s

    Number of subjects in period 1
    		placebo ondansetron
    Started
    59
    61
    Completed
    55
    54
    Not completed
    4
    7
         Consent withdrawn by subject
    3
    5
         Adverse event, non-fatal
    -
    2
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    second treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    identical appearing capsules

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ondansetron
    Arm description
    		 Ondansetron titrated from 4mg everyother day to 8mg t.d.s. as needed
    Arm type
    		 cross-over design

    Investigational medicinal product name
    ondansetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4mg ondansetron over encapsulated to all;w blinding

    Arm title
    		 placebo
    Arm description
    		 placebo dose titrated from 1 every other day to 2 t.d.s. as needed
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsule oral

    Number of subjects in period 2
    		ondansetron placebo
    Started
    55
    54
    Completed
    51
    47
    Not completed
    4
    7
         Consent withdrawn by subject
    3
    4
         Adverse event, non-fatal
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo tablets titrated from 1 daily or every other day up to 2 t.d.s

    Reporting group title
    ondansetron
    Reporting group description
    		 ondansetron 4mg tablets titrated from 1 daily or every other day up to 2 t.d.s

    Reporting group values
    		 placebo ondansetron Total
    Number of subjects
    		 59 61 120
    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
        arithmetic mean (standard deviation)
    		 41.1 ± 12 40.6 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    		 41 46 87
        Male
    		 18 15 33

    End points

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    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo tablets titrated from 1 daily or every other day up to 2 t.d.s

    Reporting group title
    ondansetron
    Reporting group description
    		 ondansetron 4mg tablets titrated from 1 daily or every other day up to 2 t.d.s
    Reporting group title
    ondansetron
    Reporting group description
    		 Ondansetron titrated from 4mg everyother day to 8mg t.d.s. as needed

    Reporting group title
    placebo
    Reporting group description
    		 placebo dose titrated from 1 every other day to 2 t.d.s. as needed

    Primary: stool consistency

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    End point title
    		 stool consistency
    End point description
    average of daily stool form scores using bristol stool form score
    End point type
    Primary
    End point timeframe
    last 2 weeks of treatment
    End point values
    		 placebo ondansetron ondansetron placebo
    Number of subjects analysed
    59
    61
    55
    54
    Units: bristol stool form score
        number (confidence interval 95%)
    4.9 (2.9 to 6.9)
    4.0 (1.2 to 6.8)
    4.8 (2.8 to 7.0)
    3.9 (1.8 to 6.1)
    Statistical analysis title
    		 analysis
    Statistical analysis description
    Analysis was carried out with Stata 12. First, intention-to-treat analysis (ITT) was carried out with available data. Second, the data were re-analysed as per protocol (PPA). Baseline variables were analysed by dropout status with t test, Kruskal–Wallis test Garsed K, et al. Gut 2014;63:1617–1625. doi:10.1136/gutjnl-2013-305989 1619 Neurogastroenterology Downloaded from gut.bmj.com on September 3, 2014 - Published by group.bmj.com or χ2 test for symmetrical, skewed or categorical variable
    Comparison groups
    placebo v ondansetron v ondansetron v placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.6
    Variability estimate
    Standard deviation
    Dispersion value
    0.15

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during treatment periods
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    ondansetron treatment
    Reporting group description
    		 -

    Reporting group title
    placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 ondansetron treatment placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 113 (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: 2%
    Non-serious adverse events
    		 ondansetron treatment placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 116 (2.59%)
    3 / 113 (2.65%)
    General disorders and administration site conditions
    lack of efficacy
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 116 (2.59%)
    0 / 113 (0.00%)
         occurrences all number
    3
    0
    abdominal pain
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24334242
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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
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