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    Clinical Trial Results:
    A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks.

    Summary
    EudraCT number
    		 2012-005587-94
    Trial protocol
    		 BE   DE   CZ   GB   PL  
    Global end of trial date
    15 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2018
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000079
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01827592
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring International Pharmascience Center US, Inc.
    Sponsor organisation address
    100 Interpace Parkway, Parsippany, NJ , United States, 07054
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.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
    28 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate efficacy of elobixibat treatment - at 5 mg and 10 mg daily doses - assessed as overall Complete Spontaneous Bowel Movement (CSBM) response, in patients with Chronic Idiopathic Constipation (CIC) during 26 Week Treatment Period.
    Protection of trial subjects
    Before obtaining the consent from patients, the Investigator appropriately explained the aims, methods, anticipated benefits, potential hazards, and any other aspects of the trial which are relevant to the patient’s decision to participate, in a language understood by the patient. The Investigator explained to the patients about their right of freedom to refuse to enter the trial or to withdraw from it at any time, without any consequences on their further care and without the need to justify their decision. The trial was conducted in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines. Bisacodyl 10 mg suppository (DULCOLAX) was used as rescue medication. It was allowed for treatment of significantly worsened constipation and its use was recorded in the PDA.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2013
    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: 17
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    South Africa: 39
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    United States: 228
    Worldwide total number of subjects
    376
    EEA total number of subjects
    92
    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)
    335
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 For this trial, a total of 84 sites were initiated in Belgium, Canada, Czech Republic, Germany, Israel, United Kingdom (UK), Poland, United States of America (USA) and South Africa. Of these, 71 sites screened patients from 30th April 2013 to 15th May 2104.

    Pre-assignment
    Screening details
    		 The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomisation to a 26-week Treatment Period. A total of 909 patients were screened in the trial and of these 533 patients were excluded due to screening failure.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EBX 10
    Arm description
    		 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Arm title
    		 EBX 5
    Arm description
    		 Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat 5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Arm title
    		 PLCBO
    Arm description
    		 Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
    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
    Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Number of subjects in period 1
    		EBX 10 EBX 5 PLCBO
    Started
    126
    126
    124
    Safety Analysis set
    125
    126
    124
    Completed
    52
    46
    48
    Not completed
    74
    80
    76
         Consent withdrawn by subject
    12
    11
    11
         Physician decision
    -
    2
    1
         Others
    -
    1
    3
         Adverse event, non-fatal
    11
    9
    2
         Patient's substantial non-compliance
    1
    1
    6
         Lost to follow-up
    1
    2
    2
         Protocol deviation
    2
    1
    -
         Trial terminated by Sponsor
    47
    53
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EBX 10
    Reporting group description
    		 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Reporting group values
    		 EBX 10 EBX 5 PLCBO Total
    Number of subjects
    		 126 126 124 376
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 110 113 112 335
        >=65 years
    		 16 13 12 41
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48 ( 14.3 ) 45.8 ( 14.1 ) 46.1 ( 14.4 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 104 107 103 314
        Male
    		 22 19 21 62
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 26 32 28 86
        Not Hispanic or Latino
    		 100 94 96 290
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1 2
        Asian
    		 2 4 7 13
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 28 23 29 80
        White
    		 95 97 87 279
        More than one race
    		 0 2 0 2
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Canada
    		 6 6 5 17
        Czech Republic
    		 2 2 2 6
        Belgium
    		 2 2 2 6
        United States
    		 73 78 77 228
        Poland
    		 2 1 0 3
        United Kingdom
    		 12 10 9 31
        South Africa
    		 14 11 14 39
        Germany
    		 15 16 15 46
    Weekly number of CSBM
    Complete Spontaneous Bowel Movement (CSBM) was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).
    Units: Number
        arithmetic mean (standard deviation)
    		 0.36 ( 0.66 ) 0.44 ( 0.75 ) 0.54 ( 0.82 ) -
    Weekly number of SBM
    Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of a laxative use or manual disimpaction.
    Units: Number
        arithmetic mean (standard deviation)
    		 2.2 ( 1.34 ) 2.13 ( 1.27 ) 2.31 ( 1.43 ) -

    End points

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    End points reporting groups
    Reporting group title
    EBX 10
    Reporting group description
    		 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Primary: Overall CSBM Response (Rate)

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    End point title
    		 Overall CSBM Response (Rate) [1]
    End point description
    This measure is a rate where a CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the first 12-weeks of the 26-week Treatment Period, including at least 3 weeks in Weeks 9-12.
    End point type
    Primary
    End point timeframe
    During the first 12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to the early termination of the study, outcomes were presented only for descriptive purposes.
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Percentage of patients
        number (confidence interval 95%)
    15.9 (10.5 to 23.5)
    22.3 (15.8 to 30.5)
    10.7 (6.4 to 17.4)
    No statistical analyses for this end point

    Secondary: Occurrence of CSBM Response (Rate)

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    End point title
    		 Occurrence of CSBM Response (Rate)
    End point description
    This measure is a rate where a CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).
    End point type
    Secondary
    End point timeframe
    Within the first 24 hours of treatment initiation
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Percentage of patients
        number (confidence interval 95%)
    20.7 (14.3 to 28.9)
    23.3 (16.6 to 31.8)
    9.8 (5.7 to 16.3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in weekly frequency of SBMs

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    End point title
    		 Change from Baseline in weekly frequency of SBMs
    End point description
    End point type
    Secondary
    End point timeframe
    For the overall first 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Number
        least squares mean (confidence interval 95%)
    2.04 (1.64 to 2.44)
    2.44 (2.04 to 2.84)
    1.55 (1.15 to 1.95)
    No statistical analyses for this end point

    Secondary: Change from Baseline in weekly stool consistency of SBMs

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    End point title
    		 Change from Baseline in weekly stool consistency of SBMs
    End point description
    The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly. The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 points tends towards diarrhoea.
    End point type
    Secondary
    End point timeframe
    For the overall first 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Units on BSFS
        least squares mean (confidence interval 95%)
    1.41 (1.24 to 1.58)
    1.35 (1.18 to 1.52)
    0.83 (0.66 to 1)
    No statistical analyses for this end point

    Secondary: Total Patient assessment of constipation – Quality of Life (PAC-QOL) score responder (Rate)

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    End point title
    		 Total Patient assessment of constipation – Quality of Life (PAC-QOL) score responder (Rate)
    End point description
    This measure is a rate where a PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12. PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Percentage of patients
        number (confidence interval 95%)
    34.9 (27 to 43.8)
    33.3 (25.6 to 42.1)
    25.7 (18.7 to 34.2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in weekly degree of straining of SBMs

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    End point title
    		 Change from Baseline in weekly degree of straining of SBMs
    End point description
    The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).
    End point type
    Secondary
    End point timeframe
    For the overall first 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -1.01 (-1.15 to -0.88)
    -1.04 (-1.17 to -0.91)
    -0.91 (-1.05 to -0.78)
    No statistical analyses for this end point

    Secondary: Change from Baseline in weekly abdominal bloating score

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    End point title
    		 Change from Baseline in weekly abdominal bloating score
    End point description
    The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
    End point type
    Secondary
    End point timeframe
    For the overall first 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.49 (-0.61 to -0.38)
    -0.52 (-0.63 to -0.4)
    -0.35 (-0.47 to -0.24)
    No statistical analyses for this end point

    Secondary: Change from Baseline in weekly abdominal discomfort score

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    End point title
    		 Change from Baseline in weekly abdominal discomfort score
    End point description
    The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).
    End point type
    Secondary
    End point timeframe
    For the overall first 12 weeks
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    126
    126
    124
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.43 (-0.54 to -0.32)
    -0.46 (-0.57 to -0.35)
    -0.38 (-0.49 to -0.27)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    34 weeks
    Adverse event reporting additional description
    The Investigator monitored the condition of the patient and recorded all AEs throughout the trial from the time of obtaining informed consent until the last visit (i.e. the end of the follow-up period, as applicable) in the AEs Log . Information on AEs was collected at each trial visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    EBX 10
    Reporting group description
    		 Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.

    Serious adverse events
    		 EBX 10 EBX 5 PLCBO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 125 (2.40%)
    3 / 126 (2.38%)
    1 / 124 (0.81%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 126 (0.79%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 126 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 125 (0.00%)
    0 / 126 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 126 (0.79%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 126 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 126 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 126 (0.79%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EBX 10 EBX 5 PLCBO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 125 (33.60%)
    28 / 126 (22.22%)
    23 / 124 (18.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 125 (4.80%)
    7 / 126 (5.56%)
    5 / 124 (4.03%)
         occurrences all number
    7
    7
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    18 / 125 (14.40%)
    6 / 126 (4.76%)
    7 / 124 (5.65%)
         occurrences all number
    22
    6
    11
    Diarrhoea
         subjects affected / exposed
    11 / 125 (8.80%)
    9 / 126 (7.14%)
    3 / 124 (2.42%)
         occurrences all number
    21
    14
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 125 (8.00%)
    7 / 126 (5.56%)
    11 / 124 (8.87%)
         occurrences all number
    10
    7
    12
    Urinary tract infection
         subjects affected / exposed
    7 / 125 (5.60%)
    5 / 126 (3.97%)
    3 / 124 (2.42%)
         occurrences all number
    8
    6
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2013
    A substantial amendment was made which included - Addition of two secondary efficacy endpoints related to QoL, Clarifications of Inclusion/Exclusion criteria Clarification of definition of treatment periods and visit-related procedures related to specific treatment periods; adjustment of visit window (Visit 2) Clarification of IMP intake (last day of IMP intake, instruction on missed IMP intake), Change in number of allowed rescue medication during Pretreatment Period. Statistical methods: PDA to be used for formal analysis of compliance; change in statistical model for the analysis of key secondary endpoints (and other minor changes).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Jan 2014
    The trial was early terminated due to a distribution issue with the trial medication.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the early termination of the study, outcomes were presented only for descriptive purposes.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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