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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 12 Weeks Followed by a 4-week Withdrawal Period

    Summary
    EudraCT number
    		 2012-005588-28
    Trial protocol
    		 SE   DE   SK   HU   CZ   GB   PL  
    Global end of trial date
    26 Apr 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
    000080
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01833065
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring International Pharmascience Center US, Inc.
    Sponsor organisation address
    100 Interpace Parkway Unite, 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
    19 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 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 12 Week Treatment Period followed by a 4 Week Withdrawal 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: 4
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Hungary: 42
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    South Africa: 32
    Country: Number of subjects enrolled
    Slovakia: 13
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    United States: 158
    Worldwide total number of subjects
    314
    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)
    262
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 For this trial, total of 86 sites in the Canada, Czech Republic, Germany, Hungary, Poland, Slovakia, Sweden, United Kingdom (UK), Unites States of America (USA), and South Africa were initiated. Of these, 79 sites enrolled the patients from 30th April 2013 to 26th April 2014.

    Pre-assignment
    Screening details
    		 The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomisation to a 12-week Treatment Period. A total of 797 patients were screened while 483 patients were excluded due to screening failure in the trial.

    Period 1
    Period 1 title
    Baseline Visit
    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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat
    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.

    Arm title
    		 EBX 5
    Arm description
    		 Elobixibat 5 mg/day was administered orally in a tablet form.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat
    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.

    Arm title
    		 PLCBO
    Arm description
    		 Placebo was administered orally in a tablet form.
    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.

    Number of subjects in period 1
    		EBX 10 EBX 5 PLCBO
    Started
    103
    100
    111
    Completed
    103
    100
    111
    Period 2
    Period 2 title
    Treatment and Withdrawal Period
    Is this the baseline period?
    		 No
    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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat
    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.

    Arm title
    		 EBX 5
    Arm description
    		 Elobixibat 5 mg/day was administered orally in a tablet form.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elobixibat
    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.

    Arm title
    		 PLCBO
    Arm description
    		 Placebo was administered orally in a tablet form.
    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.

    Number of subjects in period 2 [1]
    		EBX 10 EBX 5 PLCBO
    Started
    118
    85
    110
    Completed
    81
    64
    74
    Not completed
    37
    21
    36
         Consent withdrawn by subject
    8
    7
    11
         Trial terminated by sponsor
    16
    10
    13
         Others
    3
    2
    4
         Adverse event, non-fatal
    7
    2
    3
         Patient's substantial non-compliance
    1
    -
    -
         Lost to follow-up
    1
    -
    3
         Protocol deviation
    1
    -
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: After Baseline Visit, few patients randomised to elobixibat 5 mg/day treatment received 10 mg/day treatment in actual - due to distribution issue with the trial medication - and hence counted in elobixiabt 10 mg/day group.

    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.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form.

    Reporting group values
    		 EBX 10 EBX 5 PLCBO Total
    Number of subjects
    		 103 100 111 314
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 87 87 88 262
        From 65-84 years
    		 16 13 23 52
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 49.6 ( 14.3 ) 49.5 ( 13.5 ) 48 ( 16.1 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 84 85 97 266
        Male
    		 19 15 14 48
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 9 11 29
        Not Hispanic or Latino
    		 94 91 100 285
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 1 2 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 16 13 16 45
        White
    		 85 86 93 264
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Canada
    		 1 2 1 4
        Czech Republic
    		 2 2 0 4
        Sweden
    		 1 2 3 6
        Hungary
    		 15 13 14 42
        United States
    		 49 54 55 158
        Poland
    		 3 4 3 10
        South Africa
    		 12 7 13 32
        United Kingdom
    		 11 9 12 32
        Slovakia
    		 5 3 5 13
        Germany
    		 4 4 5 13
    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)
    		 0.33 ( 0.62 ) 0.32 ( 0.62 ) 0.43 ( 0.68 ) -
    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)
    		 2.31 ( 1.27 ) 2.19 ( 1.13 ) 2.45 ( 1.35 ) -

    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.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form.
    Reporting group title
    EBX 10
    Reporting group description
    		 Elobixibat 10 mg/day was administered orally in a tablet form.

    Reporting group title
    EBX 5
    Reporting group description
    		 Elobixibat 5 mg/day was administered orally in a tablet form.

    Reporting group title
    PLCBO
    Reporting group description
    		 Placebo was administered orally in a tablet form.

    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 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.
    End point type
    Primary
    End point timeframe
    For the overall 12-week Treatment Period
    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
    103
    100
    111
    Units: Percentage of patients
        number (confidence interval 95%)
    12.6 (7.5 to 20.6)
    14.9 (9.2 to 23.4)
    7.9 (4.1 to 14.5)
    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 first 24 hours of treatment initiation
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Percentage of patients
        number (confidence interval 95%)
    20.9 (14 to 30)
    12.6 (7.4 to 20.8)
    12.2 (7.3 to 19.6)
    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 12-week Treatment Period
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Number
        least squares mean (confidence interval 95%)
    2.25 (1.78 to 2.71)
    2.4 (1.92 to 2.88)
    1.2 (0.74 to 1.66)
    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 12-week Treatment Period
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Units on BSFS
        least squares mean (confidence interval 95%)
    1.56 (1.35 to 1.77)
    1.45 (1.24 to 1.66)
    0.8 (0.6 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 Week 12
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Percentage of patients
        number (confidence interval 95%)
    32.6 (24 to 42.4)
    31.5 (22.8 to 41.8)
    19.2 (12.7 to 27.9)
    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
    End point type
    Secondary
    End point timeframe
    For the overall 12-week Treatment Period
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.9 (-1.03 to -0.77)
    -0.84 (-0.97 to -0.71)
    -0.63 (-0.76 to -0.5)
    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 12-weekTreatment Period
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.46 (-0.56 to -0.36)
    -0.35 (-0.46 to -0.25)
    -0.3 (-0.4 to -0.2)
    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 12-week Treatment Period
    End point values
    		 EBX 10 EBX 5 PLCBO
    Number of subjects analysed
    103
    100
    111
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.37 (-0.48 to -0.27)
    -0.32 (-0.43 to -0.22)
    -0.25 (-0.36 to -0.15)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    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/EBX 10
    Reporting group description
    		 Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.

    Reporting group title
    EBX 10/PLCBO
    Reporting group description
    		 Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.

    Reporting group title
    EBX 5/EBX 5
    Reporting group description
    		 Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.

    Reporting group title
    EBX 5/PLCBO
    Reporting group description
    		 Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.

    Reporting group title
    PLCBO/EBX 10
    Reporting group description
    		 Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.

    Serious adverse events
    		 EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    1 / 50 (2.00%)
    3 / 110 (2.73%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    0 / 50 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    1 / 50 (2.00%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    0 / 50 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hysterectomy
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    0 / 50 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    0 / 50 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    0 / 35 (0.00%)
    0 / 50 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EBX 10/EBX 10 EBX 10/PLCBO EBX 5/EBX 5 EBX 5/PLCBO PLCBO/EBX 10
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 65 (38.46%)
    11 / 53 (20.75%)
    13 / 35 (37.14%)
    20 / 50 (40.00%)
    24 / 110 (21.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 65 (4.62%)
    0 / 53 (0.00%)
    2 / 35 (5.71%)
    0 / 50 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    3
    0
    5
    0
    2
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 53 (0.00%)
    2 / 35 (5.71%)
    0 / 50 (0.00%)
    0 / 110 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 65 (20.00%)
    2 / 53 (3.77%)
    1 / 35 (2.86%)
    5 / 50 (10.00%)
    4 / 110 (3.64%)
         occurrences all number
    17
    12
    2
    7
    5
    Abdominal pain
         subjects affected / exposed
    9 / 65 (13.85%)
    3 / 53 (5.66%)
    2 / 35 (5.71%)
    1 / 50 (2.00%)
    6 / 110 (5.45%)
         occurrences all number
    11
    3
    2
    1
    9
    Nausea
         subjects affected / exposed
    6 / 65 (9.23%)
    0 / 53 (0.00%)
    1 / 35 (2.86%)
    0 / 50 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    6
    0
    1
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 53 (1.89%)
    0 / 35 (0.00%)
    3 / 50 (6.00%)
    1 / 110 (0.91%)
         occurrences all number
    3
    1
    0
    3
    1
    Abdominal pain lower
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 53 (0.00%)
    2 / 35 (5.71%)
    0 / 50 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    2
    0
    3
    0
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 53 (3.77%)
    1 / 35 (2.86%)
    4 / 50 (8.00%)
    5 / 110 (4.55%)
         occurrences all number
    2
    2
    1
    4
    5
    Sinusitis
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 53 (5.66%)
    0 / 35 (0.00%)
    3 / 50 (6.00%)
    1 / 110 (0.91%)
         occurrences all number
    3
    3
    0
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 53 (1.89%)
    2 / 35 (5.71%)
    3 / 50 (6.00%)
    3 / 110 (2.73%)
         occurrences all number
    1
    1
    2
    3
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 53 (1.89%)
    1 / 35 (2.86%)
    4 / 50 (8.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    1
    1
    5
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2013
    A substantial amendment was made which included - Adjustment of the visit window of Visit 2, Adjustment of inclusion/exclusion criteria, Addition of exploratory endpoints Clarification of IMP intake (last day of IMP intake, instruction on missed IMP intake), Clarifications of treatment and withdrawal periods Statistical methods: PDA to be used for formal analysis of compliance; change in statistical model for the analysis of key secondary endpoints and handling of missing doses (and other minor changes). Addition of two secondary efficacy endpoints related to QoL.

    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.
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