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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

    Summary
    EudraCT number
    		 2012-001601-24
    Trial protocol
    		 GB  
    Global end of trial date
    09 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2018
    First version publication date
    19 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    27018966IBS3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01553747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan Pharmaceutical International Ltd
    Sponsor organisation address
    Clonshaugh Business & Technology Park, Coolock, Dublin,, Ireland, D17 E400
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.com
    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
    09 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study was to evaluate the clinical response of participants with irritable bowel syndrome, diarrhea predominant (IBS-d) to eluxadoline, relative to placebo and evaluation of the overall safety and tolerability of eluxadoline in the treatment of IBS-d for up to 26 weeks.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 May 2012
    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
    Canada: 16
    Country: Number of subjects enrolled
    Puerto Rico: 32
    Country: Number of subjects enrolled
    United Kingdom: 1097
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    1146
    EEA total number of subjects
    1097
    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)
    1020
    From 65 to 84 years
    126
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 3356 participants were prescreened and entered into interactive voice response system for participation in the study. 1146 participants were randomised. One participant was unintentionally randomised twice and was assigned 2 different participant identification numbers due to participant trying to participate at more than 1 study center at once.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eluxadoline 75 mg
    Arm description
    		 Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eluxadoline
    Investigational medicinal product code
    Other name
    JNJ-27018966
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eluxadoline tablets, orally, twice daily for up to 26 weeks period.

    Arm title
    		 Eluxadoline 100 mg
    Arm description
    		 Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eluxadoline
    Investigational medicinal product code
    Other name
    JNJ-27018966
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eluxadoline tablets, orally, twice daily for up to 26 weeks period.

    Arm title
    		 Placebo
    Arm description
    		 Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.

    Number of subjects in period 1
    		Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Started
    381
    383
    382
    Attended Week 12 visit
    296
    301
    312
    Attended Week 26 visit
    259
    271
    278
    Participated in Blinded-Placebo Period
    246 [1]
    253 [2]
    272 [3]
    Completed
    250
    264
    273
    Not completed
    131
    119
    109
         Voluntarily withdrew
    70
    66
    74
         Physician decision: other
    10
    8
    7
         Physician decision: lack of efficacy
    1
    5
    3
         Sponsor decision, specify
    7
    5
    -
         Adverse event or SAE
    32
    28
    19
         Lost to follow-up
    11
    5
    6
         Protocol deviation
    -
    2
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects to complete the study is based on the 26-week randomized treatment period. The 4-week blinded placebo period occurs only after the completion of the 26-week randomized treatment period.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects to complete the study is based on the 26-week randomized treatment period. The 4-week blinded placebo period occurs only after the completion of the 26-week randomized treatment period.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects to complete the study is based on the 26-week randomized treatment period. The 4-week blinded placebo period occurs only after the completion of the 26-week randomized treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eluxadoline 75 mg
    Reporting group description
    		 Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Reporting group title
    Eluxadoline 100 mg
    Reporting group description
    		 Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Reporting group title
    Placebo
    Reporting group description
    		 Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Reporting group values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo Total
    Number of subjects
    		 381 383 382 1146
    Age, Customized
    Units: Subjects
        18-40 years
    		 139 146 133 418
        41-64 years
    		 206 198 198 602
        ≥65 years
    		 36 39 51 126
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.0 ( 13.17 ) 45.7 ( 13.31 ) 47.1 ( 13.82 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 261 257 250 768
        Male
    		 120 126 132 378

    End points

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    End points reporting groups
    Reporting group title
    Eluxadoline 75 mg
    Reporting group description
    		 Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Reporting group title
    Eluxadoline 100 mg
    Reporting group description
    		 Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Reporting group title
    Placebo
    Reporting group description
    		 Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks treatment period followed by placebo orally, twice daily for next 4 weeks of blinded-placebo period.

    Primary: Percentage of Participants who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores

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    End point title
    		 Percentage of Participants who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
    End point description
    Composite responders: Participants who met daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must have met following criteria on given day to be daily responder:1) Daily pain response: worst abdominal pain scores in past 24 hours improved by ≥30% compared to baseline. 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. BSS is defined as 7-point Scale in which score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, 7 = watery with no solid pieces. Intent to Treat (ITT) analysis set: All participants who were randomised and presents data for participants according to their randomisation assignment.
    End point type
    Primary
    End point timeframe
    Up to 26 weeks
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
        number (not applicable)
    30.4
    32.7
    20.2
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The composite responder was analyzed using the CMH (Chi-square) test. The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
    Comparison groups
    Eluxadoline 75 mg v Placebo
    Number of subjects included in analysis
    763
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.001 [1]
    Method
    		 Chi-square test statistic
    Confidence interval
    Notes
    [1] - Chi-square test at 0.025 significance level
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The composite responder was analyzed using the CMH (Chi-square) test. The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
    Comparison groups
    Eluxadoline 100 mg v Placebo
    Number of subjects included in analysis
    764
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [2]
    Method
    		 Chi-square test statistic
    Confidence interval
    Notes
    [2] - Chi-square test at 0.025 significance level

    Secondary: Percentage of Participants who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores

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    End point title
    		 Percentage of Participants who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
    End point description
    Composite responders: Participants who met daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must have met following criteria on given day to be daily responder:1) Daily pain response: worst abdominal pain scores in past 24 hours improved by ≥30% compared to baseline. 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. BSS is defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, 7 = watery with no solid pieces. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
        number (not applicable)
    28.9
    29.6
    16.2
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The composite responder was analyzed using the CMH (Chi-square) test. The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
    Comparison groups
    Placebo v Eluxadoline 75 mg
    Number of subjects included in analysis
    763
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [3]
    Method
    		 Chi-square test statistic
    Confidence interval
    Notes
    [3] - Chi-square test at 0.025 significance level
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The composite responder was analyzed using the CMH (Chi-square) test. The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.
    Comparison groups
    Eluxadoline 100 mg v Placebo
    Number of subjects included in analysis
    764
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [4]
    Method
    		 Chi-square test statistic
    Confidence interval
    Notes
    [4] - Chi-square test at 0.025 significance level

    Secondary: Percentage of Participants who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals

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    End point title
    		 Percentage of Participants who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
    End point description
    Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
    number (not applicable)
        Responders during Weeks 1-12
    48.0
    51.0
    45.3
        Responders during Weeks 1-26
    47.5
    50.0
    44.8
        Responders during Weeks 1-4
    46.7
    46.6
    41.9
        Responders during Weeks 5-8
    53.0
    52.9
    49.2
        Responders during Weeks 9-12
    48.0
    50.3
    46.9
        Responders during Weeks 13-16
    47.2
    49.0
    43.5
        Responders during Weeks 17-20
    45.1
    47.4
    42.7
        Responders during Weeks 21-24
    41.7
    46.9
    40.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Were Responders In Daily Stool Consistency Scores by Intervals

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    End point title
    		 Percentage of Participants who Were Responders In Daily Stool Consistency Scores by Intervals
    End point description
    Stool consistency responders: Participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
    number (not applicable)
        Responders during Weeks 1-12
    37.0
    35.6
    20.9
        Responders during Weeks 1-26
    34.4
    39.8
    23.6
        Responders during Weeks 1-4
    34.6
    37.2
    18.1
        Responders during Weeks 5-8
    37.5
    38.2
    23.3
        Responders during Weeks 9-12
    37.5
    39.3
    26.4
        Responders during Weeks 13-16
    36.2
    41.4
    24.9
        Responders during Weeks 17-20
    33.9
    36.1
    24.9
        Responders during Weeks 21-24
    32.5
    38.2
    22.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals

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    End point title
    		 Percentage of Participants who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
    End point description
    IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5-point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
    number (not applicable)
        Responders during Weeks 1-12
    43.6
    42.4
    29.6
        Responders during Weeks 1-26
    45.1
    43.2
    34.3
        Responders during Weeks 1-4
    40.2
    36.9
    25.7
        Responders during Weeks 5-8
    45.1
    45.0
    35.1
        Responders during Weeks 9-12
    44.9
    43.5
    34.0
        Responders during Weeks 13-16
    43.8
    42.9
    33.0
        Responders during Weeks 17-20
    42.5
    40.8
    33.2
        Responders during Weeks 21-24
    41.7
    41.6
    33.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale

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    End point title
    		 Percentage of Participants who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
    End point description
    IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
    number (not applicable)
        Responders at Week 4
    45.1
    45.5
    40.1
        Responders at Week 8
    48.8
    50.0
    43.7
        Responders at Week 12
    48.3
    49.5
    45.0
        Responders at Week 18
    45.1
    45.0
    41.9
        Responders at Week 26
    45.4
    44.8
    41.4
        Responders at Week 30 /EOT
    54.3
    53.9
    52.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Irritable Bowel Syndrome – Adequate Relief (IBS-AR) Scale

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    End point title
    		 Percentage of Participants With Irritable Bowel Syndrome – Adequate Relief (IBS-AR) Scale
    End point description
    Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of “Yes” to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment.
    End point type
    Secondary
    End point timeframe
    12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: percentage of participants
    number (not applicable)
        Responders during Weeks 1-12
    60.1
    58.4
    49.2
        Responders during Weeks 1-26
    52.8
    53.7
    43.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in Daily Abdominal Discomfort Scores

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    End point title
    		 Change From Baseline in Daily Abdominal Discomfort Scores
    End point description
    Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change at Week 4 (n= 348, 351, 364)
    -2.44 ( 2.219 )
    -2.19 ( 2.120 )
    -2.06 ( 2.063 )
        Change at Week 12 (n= 298, 303, 316)
    -2.88 ( 2.417 )
    -2.90 ( 2.175 )
    -2.56 ( 2.461 )
        Change at Week 26 (n= 255, 267, 267)
    -3.19 ( 2.454 )
    -3.16 ( 2.362 )
    -2.76 ( 2.582 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Daily Abdominal Bloating Scores

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    End point title
    		 Change From Baseline in Daily Abdominal Bloating Scores
    End point description
    Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change at Week 4 (n= 292, 305, 302)
    -1.89 ( 2.170 )
    -1.80 ( 2.204 )
    -1.73 ( 2.081 )
        Change at Week 12 (n= 247, 262, 259)
    -2.24 ( 2.445 )
    -2.41 ( 2.396 )
    -2.08 ( 2.492 )
        Change at Week 26 (n= 210, 229, 214)
    -2.38 ( 2.619 )
    -2.68 ( 2.673 )
    -2.17 ( 2.682 )
    No statistical analyses for this end point

    Secondary: Number of Bowel Movements per Day

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    End point title
    		 Number of Bowel Movements per Day
    End point description
    Participants recorded the number of bowel movements over 24 hours daily throughout the treatment. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: number of bowel movements
    arithmetic mean (standard deviation)
        Week 4 (n= 348, 351, 364)
    3.03 ( 2.021 )
    3.05 ( 1.962 )
    3.38 ( 1.856 )
        Week 12 (n= 298, 303, 316)
    2.89 ( 2.057 )
    2.80 ( 1.685 )
    3.15 ( 1.991 )
        Week 26 (n= 255, 267, 267)
    2.57 ( 1.637 )
    2.66 ( 1.625 )
    2.96 ( 1.931 )
    No statistical analyses for this end point

    Secondary: Number of Bowel Incontinence Episodes

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    End point title
    		 Number of Bowel Incontinence Episodes
    End point description
    Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: incontinence episodes
    arithmetic mean (standard deviation)
        Week 4 (n= 348, 351, 364)
    0.47 ( 1.304 )
    0.41 ( 1.230 )
    0.50 ( 1.195 )
        Week 12 (n= 298, 303, 316)
    0.40 ( 1.083 )
    0.28 ( 0.875 )
    0.46 ( 1.269 )
        Week 26 (n= 255, 267, 267)
    0.30 ( 0.982 )
    0.27 ( 0.844 )
    0.50 ( 1.503 )
    No statistical analyses for this end point

    Secondary: Number of Bowel Incontinence Free Days

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    End point title
    		 Number of Bowel Incontinence Free Days
    End point description
    An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: days
    arithmetic mean (standard deviation)
        Week 4 (n= 348, 351, 364)
    5.53 ( 2.282 )
    5.46 ( 2.264 )
    5.31 ( 2.444 )
        Week 12 (n= 298, 303, 316)
    5.38 ( 2.320 )
    5.56 ( 2.164 )
    5.28 ( 2.364 )
        Week 26 (n= 255, 267, 267)
    5.53 ( 2.129 )
    5.59 ( 2.216 )
    5.29 ( 2.322 )
    No statistical analyses for this end point

    Secondary: Number of Urgency Episodes per Day

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    End point title
    		 Number of Urgency Episodes per Day
    End point description
    Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 12 and 26
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: episode
    arithmetic mean (standard deviation)
        Week 4 (n= 348, 351, 364)
    1.62 ( 1.948 )
    1.58 ( 1.732 )
    2.00 ( 1.779 )
        Week 12 (n= 298, 303, 316)
    1.37 ( 1.884 )
    1.32 ( 1.675 )
    1.73 ( 1.785 )
        Week 26 (n= 255, 267, 267)
    1.13 ( 1.580 )
    1.12 ( 1.576 )
    1.54 ( 1.826 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in IBS-QoL Total Scores

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    End point title
    		 Change From Baseline in IBS-QoL Total Scores
    End point description
    The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved. ITT analysis set included all participants who were randomised into a treatment group and presents data for participants according to their randomisation assignment. Here, “n” indicates the number of participants who were evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT
    End point values
    		 Eluxadoline 75 mg Eluxadoline 100 mg Placebo
    Number of subjects analysed
    381
    382
    382
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change at Week 4 (n= 335, 342, 357)
    17.51 ( 19.755 )
    17.26 ( 18.980 )
    14.07 ( 18.787 )
        Change at Week 8 (n= 318, 319, 333)
    21.60 ( 20.762 )
    21.10 ( 21.925 )
    16.62 ( 20.856 )
        Change at Week 12 (n= 293, 300, 311)
    22.69 ( 21.723 )
    22.62 ( 24.017 )
    19.50 ( 21.636 )
        Change at Week 18 (n= 275, 281, 293)
    24.17 ( 22.761 )
    23.52 ( 24.029 )
    20.64 ( 23.268 )
        Change at Week 26 (n= 258, 271, 277)
    24.91 ( 22.638 )
    24.19 ( 24.599 )
    21.50 ( 23.709 )
        Change at Week 30/EOT (n= 335, 344, 342)
    22.79 ( 22.329 )
    20.92 ( 23.724 )
    21.63 ( 23.376 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 30 weeks
    Adverse event reporting additional description
    Safety Set: all participants who received at least 1 dose of drug per actual treatment received. 1 participant in 100 mg arm received 75 mg, 2 participants in Placebo arm received eluxadoline 75 mg and 100 mg. AEs for each period were analyzed separately. In the Non Serious AE section, a result of 0 in an arm means the ≥5% threshold was not met.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Eluxadoline 75 mg (Treatment Period)
    Reporting group description
    		 Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.

    Reporting group title
    Eluxadoline 100 mg (Treatment Period)
    Reporting group description
    		 Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.

    Reporting group title
    Placebo (Treatment Period)
    Reporting group description
    		 Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.

    Reporting group title
    Eluxadoline 75 mg (Blinded-Placebo Period)
    Reporting group description
    		 Participants who received eluxadoline 75 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.

    Reporting group title
    Eluxadoline 100 mg (Blinded-Placebo Period)
    Reporting group description
    		 Participants who received eluxadoline 100 mg in treatment period were administered with placebo orally, twice daily for next 4 weeks.

    Reporting group title
    Placebo (Blinded-Placebo Period)
    Reporting group description
    		 Participants who received placebo matching tablets in treatment period were administered with placebo orally, twice daily for next 4 weeks.

    Serious adverse events
    		 Eluxadoline 75 mg (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 379 (2.37%)
    14 / 380 (3.68%)
    8 / 381 (2.10%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 379 (0.26%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac pain
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ECG T wave abnormal
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomeningocele
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischemic
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 379 (0.26%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infections
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 379 (0.00%)
    0 / 380 (0.00%)
    1 / 381 (0.26%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 379 (0.26%)
    0 / 380 (0.00%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 379 (0.00%)
    1 / 380 (0.26%)
    0 / 381 (0.00%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eluxadoline 75 mg (Treatment Period) Eluxadoline 100 mg (Treatment Period) Placebo (Treatment Period) Eluxadoline 75 mg (Blinded-Placebo Period) Eluxadoline 100 mg (Blinded-Placebo Period) Placebo (Blinded-Placebo Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    97 / 379 (25.59%)
    97 / 380 (25.53%)
    69 / 381 (18.11%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 379 (3.69%)
    23 / 380 (6.05%)
    22 / 381 (5.77%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences all number
    15
    26
    23
    0
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    33 / 379 (8.71%)
    30 / 380 (7.89%)
    8 / 381 (2.10%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences all number
    35
    32
    12
    0
    0
    0
    Nausea
         subjects affected / exposed
    31 / 379 (8.18%)
    33 / 380 (8.68%)
    22 / 381 (5.77%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences all number
    36
    34
    24
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 379 (5.01%)
    13 / 380 (3.42%)
    15 / 381 (3.94%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences all number
    20
    15
    17
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 379 (3.43%)
    22 / 380 (5.79%)
    17 / 381 (4.46%)
    0 / 246 (0.00%)
    0 / 253 (0.00%)
    0 / 272 (0.00%)
         occurrences all number
    13
    22
    19
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2012
    Included feedback from regulatory agencies (US FDA and EMA) regarding the efficacy endpoints, clarified eligibility criteria, and clarified the timing of assessments. The following changes affecting study conduct were specified: • added daily assessment of abdominal discomfort to electronic diary collection • clarified eligibility criteria and added exclusion criteria for lactose intolerance and gastrointestinal infection • added triglycerides evaluation at Baseline and clarified lipase and triglyceride evaluations should be completed for any participant with confirmed or suspected pancreatitis • added tramadol to the list of prohibited medications
    24 Aug 2012
    Clarified eligibility criteria and the reporting period for pregnancies, and modified administrative language related to Investigator obligations. The following changes affecting study conduct were specified: • Clarified eligibility criteria and added microscopic colitis as an example of an excluded inflammatory bowel disease • Changed the pregnancy reporting requirement from the start of the study to the time of the first dose of study drug to be consistent with the inclusion criteria
    30 Oct 2012
    Clarified eligibility criteria, clarified electronic diary notifications, added guidance in the event of elevated liver enzymes, and noted the procedures that should be performed prior to randomization. The following changes affecting study conduct were specified: • clarified eligibility criteriaparticipant • clarified that the electronic diary determines whether a participant met the study entry criteria for diary compliance, loperamide rescue medication use, and averages of worst abdominal pain, BSS, and IBS-d global symptoms, but does not send a notification of eligibility to the sites • clarified that Investigators must re-verify the participant meets all inclusion/exclusion criteria at the time of randomization • added guidance in the event of elevation in liver enzymes, including the timing of repeat labs and the criteria for withdrawal from the study
    04 Dec 2013
    Incorporated recent scientific advice from the EMA and clarified a change in the Medical Monitor for the study. This amendment clarified that to support a potential Marketing Authorisation Application (MAA) to the EMA, composite responder status over 26 weeks should be considered the primary efficacy endpoint rather than the previously designated co-primary endpoints of pain responder status and global symptom responder status

    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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