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    Clinical Trial Results:
    A double-blind, randomized, placebo-controlled, study to demonstrate the efficacy and safety of 250 mg or 1 g A3384 administered orally twice daily for two weeks to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)

    Summary
    EudraCT number
    		 2013-002924-17
    Trial protocol
    		 SE   GB  
    Global end of trial date
    18 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2016
    First version publication date
    18 May 2016
    Other versions
    Summary report(s)
    		 Study report summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A3384-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Albireo AB
    Sponsor organisation address
    Arvid Wallgrens Backe 20, Gothenburg, Sweden,
    Public contact
    VP Clinical & Regulatory Affairs, Albireo AB, 0046 31 74 114 81, kristina.torfgard@albireopharma.com
    Scientific contact
    Responsible Medical Officer, Albireo AB, 0046 31 741 1480,
    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
    16 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary efficacy objective of this study is to demonstrate the efficacy of twice daily oral doses of 250 mg or 1 g A3384 during a two week treatment period in patients with BAM, as determined by the # of bowel movements (BMs). The primary safety objective of this study is to assess the safety and tolerability of twice daily oral doses of 250 mg or 1 g A3384 during a two week treatment period in patients with BAM, as determined by the occurrence of treatment-emergent SAEs.
    Protection of trial subjects
    Vital signs, physical examinations, patient diary, laboratory test (such as haematology, clinical chemistry and urinalysis), concomitant medication review and adverse event data collection were performed throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2014
    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
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 11
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    14
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 There were three sites included in this study. Two sites from Sweden, site 001 in Göteborg and site 002 in Skövde and one site, site 003 in London from UK.

    Pre-assignment
    Screening details
    		 Thirty-four patients were screened for participation in the study: 19 patients (8 women and 11 men) entered the study and 15 patients were screening failures. All randomized patients completed the study and were included in both the FAS (mITT population) and the safety population.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250 mg A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (1 capsule of 250 mg A3384 + 3 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 1 g A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Capsule
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 capsules of 250 mg A3384, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 Placebo
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Number of subjects in period 1
    		250 mg A3384 1 g A3384 Placebo
    Started
    6
    7
    6
    Completed
    6
    7
    6
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250 mg A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (1 capsule of 250 mg A3384 + 3 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 1 g A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Capsule
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 capsules of 250 mg A3384, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 Placebo
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Number of subjects in period 2
    		250 mg A3384 1 g A3384 Placebo
    Started
    6
    7
    6
    Completed
    6
    7
    6
    Period 3
    Period 3 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250 mg A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (1 capsule of 250 mg A3384 + 3 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 1 g A3384
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    A3384
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Capsule
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 capsules of 250 mg A3384, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Arm title
    		 Placebo
    Arm description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Number of subjects in period 3
    		250 mg A3384 1 g A3384 Placebo
    Started
    6
    7
    6
    Completed
    6
    7
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    250 mg A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    1 g A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group values
    		 250 mg A3384 1 g A3384 Placebo Total
    Number of subjects
    		 6 7 6 19
    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)
    		 4 5 5 14
        From 65-84 years
    		 2 2 1 5
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50 ± 21.28 46.4 ± 20.4 38.7 ± 17.57 -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 3 8
        Male
    		 4 4 3 11
    Ethnic background
    Units: Subjects
        Asian
    		 0 2 1 3
        Caucasian
    		 5 5 4 14
        Other
    		 1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    250 mg A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    1 g A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Reporting group title
    250 mg A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    1 g A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.
    Reporting group title
    250 mg A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    1 g A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Primary: Change from baseline period 2 of bowel movements during second treatment week

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    End point title
    		 Change from baseline period 2 of bowel movements during second treatment week
    End point description
    The primary efficacy endpoint was the change in mean (daily) number of BMs from the baseline period 2 diary recordings to the second treatment week diary recordings.
    End point type
    Primary
    End point timeframe
    From the baseline period 2 to the second treatment week.
    End point values
    		 250 mg A3384 1 g A3384 Placebo 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    5
    6
    7
    5 [1]
    Units: Number of BM
        arithmetic mean (standard deviation)
    5.4 ± 2.8
    4.9 ± 1.5
    4.5 ± 0.9
    3.6 ± 1.6
    3.7 ± 1.9
    4.1 ± 1.3
    Notes
    [1] - One patient had too few observations, only two Days of assessments for treatment period 2.
    Statistical analysis title
    		 Change in mean (daily) number of BMs, 250 mg A3384
    Statistical analysis description
    Change from baseline
    Comparison groups
    250 mg A3384 v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.697
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.143
         upper limit
    		 1.143
    Statistical analysis title
    		 Change in mean (daily) number of BMs, 1g A3384
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3258
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.571
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.857
    Statistical analysis title
    		 Change in mean (daily) number of BMs, (1g+250mg)
    Statistical analysis description
    Combined A3384 group (1 g + 250 mg) compared to placebo from baseline period 2 to second treatment week
    Comparison groups
    250 mg A3384 v 1 g A3384 v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3985
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.429
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.857
    Statistical analysis title
    		 Change in mean (daily) number of BMs, 250 mg A3384
    Comparison groups
    250 mg A3384 v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3299
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.976
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.068
         upper limit
    		 1.117
    Statistical analysis title
    		 Change in mean (daily) number of BMs, 1g A3384
    Comparison groups
    1 g A3384 v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4855
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.658
         upper limit
    		 1.338
    Statistical analysis title
    		 Change in mean (daily) number of BMs, (1g+250mg)
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3383
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 0.939

    Secondary: Severity of diarrhoea

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    End point title
    		 Severity of diarrhoea
    End point description
    Change from Baseline in average severity of diarrhoea (daily) during the second treatment week or the last 7 Days of reporting. Patient reporting scale 0-10
    End point type
    Secondary
    End point timeframe
    From baseline to second treatment week.
    End point values
    		 250 mg A3384 1 g A3384 Placebo 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    6
    6
    7
    5
    Units: severity of diarrhoea
        arithmetic mean (standard deviation)
    6 ± 3
    5.8 ± 1.8
    4.9 ± 2.8
    3.7 ± 2.4
    4.1 ± 2.9
    5.5 ± 2.7
    Statistical analysis title
    		 Change in mean (daily) symptoms diar, 250 mg A3384
    Statistical analysis description
    Change from baseline
    Comparison groups
    250 mg A3384 v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0823
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -3.429
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.571
         upper limit
    		 1.286
    Statistical analysis title
    		 Change in mean (daily) symptoms diar, 1 g A3384
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0732
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -3.286
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.286
         upper limit
    		 0.429
    Statistical analysis title
    		 Change in mean (daily) symptoms diarrh, 1g + 250mg
    Statistical analysis description
    Change from baseline
    Comparison groups
    1 g A3384 v Placebo v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -3.286
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.554
         upper limit
    		 -0.286
    Statistical analysis title
    		 Change in mean (daily) symptoms diarrh, 250 mg
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -3.138
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.894
         upper limit
    		 -0.381
    Statistical analysis title
    		 Change in mean (daily) symptoms diarrh, 1 g
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0476
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -2.685
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.336
         upper limit
    		 -0.034
    Statistical analysis title
    		 Change in mean (daily) symptoms diarrh, 1g+250mg
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0183
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -2.889
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.204
         upper limit
    		 -0.574

    Secondary: Severity of abdominal discomfort

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    End point title
    		 Severity of abdominal discomfort
    End point description
    Change in mean (daily) severity of abdominal discomfort from baseline period 2 (last 7 Days prior to Clinical visit number 3) to the second treatment week (last 7 Days of reporting)
    End point type
    Secondary
    End point timeframe
    From baseline to second treatment week.
    End point values
    		 250 mg A3384 1 g A3384 Placebo 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    6
    6
    7
    5
    Units: severity of abdominal discomfort
        arithmetic mean (standard deviation)
    5 ± 3.5
    5 ± 2.7
    5.8 ± 1.3
    3.2 ± 1.8
    3.3 ± 3.4
    4.5 ± 2.4
    Statistical analysis title
    		 Change in mean (daily) symptoms abd discom (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7922
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.857
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.143
         upper limit
    		 3.238
    Statistical analysis title
    		 Change in mean (daily) symptoms abd discomfor (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6061
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.571
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.19
         upper limit
    		 2.286
    Statistical analysis title
    		 Change in mean (daily) symptoms abd dis (1g+250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384 v 1 g A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6162
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.714
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.19
         upper limit
    		 2.238
    Statistical analysis title
    		 Change in mean (daily) symptoms abd discom (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5246
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.931
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.028
         upper limit
    		 2.165
    Statistical analysis title
    		 Change in mean (daily) symptoms abd discomfor (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5186
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.909
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.887
         upper limit
    		 2.069
    Statistical analysis title
    		 Change in mean (daily) symptoms abd dis (1g+250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4545
    Method
    		 ANCOVA
    Parameter type
    		 LSmean estimate
    Point estimate
    -0.919
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.495
         upper limit
    		 1.656

    Secondary: Severity of abdominal bloating

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    End point title
    		 Severity of abdominal bloating
    End point description
    Change in mean (daily) severity of abdominal bloating from baseline period 2 (last 7 Days prior to clinicla visit number 3) to the second treatment week (last 7 Days of reporting)
    End point type
    Secondary
    End point timeframe
    From baseline to second treatment week.
    End point values
    		 250 mg A3384 1 g A3384 Placebo 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    6
    6
    7
    5
    Units: severity in abdominal bloating
        arithmetic mean (standard deviation)
    4.1 ± 3.9
    4.7 ± 1.8
    6 ± 1.5
    3.2 ± 2.4
    3.4 ± 2.9
    5.1 ± 2.9
    Statistical analysis title
    		 Change in mean (daily) symptoms abd bloati (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9307
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    0.357
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.881
         upper limit
    		 4.143
    Statistical analysis title
    		 Change in mean (daily) symptoms abd bloating (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.143
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.714
         upper limit
    		 2.143
    Statistical analysis title
    		 Change in mean (daily) symptoms abd blo (250mg+1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9799
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    0.143
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.229
         upper limit
    		 2
    Statistical analysis title
    		 Change in mean (daily) symptoms abd bloati (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6572
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.696
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.028
         upper limit
    		 2.636
    Statistical analysis title
    		 Change in mean (daily) symptoms abd bloating (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.573
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.841
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.004
         upper limit
    		 2.322
    Statistical analysis title
    		 Change in mean (daily) symptoms abd blo (250mg+1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5522
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.778
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.531
         upper limit
    		 1.975

    Secondary: Stool consistency

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    End point title
    		 Stool consistency
    End point description
    Change in mean (daily) stool consistency (as determined by the Bristol Stool Form Scale (BSFS)) from baseline period 2 (last 7 Days prior to clinic visit number 3) to the second treatment week (last 7 Days of reporting)
    End point type
    Secondary
    End point timeframe
    From baseline to second treatment week.
    End point values
    		 250 mg A3384 1 g A3384 Placebo 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    6
    6
    7
    5
    Units: daily stool consistency
        arithmetic mean (standard deviation)
    5.9 ± 0.7
    6.1 ± 0.6
    5.5 ± 1
    4.9 ± 1.3
    5.4 ± 1.1
    5.3 ± 1.2
    Statistical analysis title
    		 Change in mean stool consistency (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    250 mg A3384 v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0823
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -1.185
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.065
         upper limit
    		 0.327
    Statistical analysis title
    		 Change in mean stool consistency (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.149
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.515
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.784
         upper limit
    		 0.294
    Statistical analysis title
    		 Change in mean stool consistency (250mg+1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0593
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.951
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.784
         upper limit
    		 0.044
    Statistical analysis title
    		 Change in mean stool consistency (250mg)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0289
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -1.194
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.242
         upper limit
    		 -0.145
    Statistical analysis title
    		 Change in mean stool consistency (1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0908
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.882
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.927
         upper limit
    		 0.163
    Statistical analysis title
    		 Change in mean stool consistency (250mg+1g)
    Statistical analysis description
    Change from baseline
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0298
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -1.037
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.955
         upper limit
    		 -0.118

    Secondary: self-reported global symptom relief

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    End point title
    		 self-reported global symptom relief
    End point description
    Difference in patients'self-reported global symptom relief rating 1-7.
    End point type
    Secondary
    End point timeframe
    visit 4
    End point values
    		 250 mg A3384 1 g A3384 Placebo
    Number of subjects analysed
    6
    7
    6
    Units: global symptom
        arithmetic mean (standard deviation)
    3.5 ± 1.38
    3.4 ± 1.62
    4 ± 1.9
    Statistical analysis title
    		 Global symptom relief (250mg)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    250 mg A3384 v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6234
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 2
    Statistical analysis title
    		 Global symptom relief (1g)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6393
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 2
    Statistical analysis title
    		 Global symptom relief (250mg+1g)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5606
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 1
    Statistical analysis title
    		 Global symptom relief (250mg)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    Placebo v 250 mg A3384
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.525
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.748
         upper limit
    		 1.697
    Statistical analysis title
    		 Global symptom relief (1g)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    Placebo v 1 g A3384
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5689
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.579
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.707
         upper limit
    		 1.549
    Statistical analysis title
    		 Global symptom relief (250mg+1g)
    Statistical analysis description
    Change from global symptoms patient usually have when taking their regular medicine.
    Comparison groups
    Placebo v 1 g A3384 v 250 mg A3384
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5279
    Method
    		 ANCOVA
    Parameter type
    		 LSmeanestimate
    Point estimate
    -0.555
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.384
         upper limit
    		 1.275

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs, whether reported by the patient or observed by the Investigator/Investigative Staff, were recorded throughout the study, starting after the patient had signed the ICF and until the post-treatment follow-up (visit 5) 7 days after the final dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    250 mg A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 1 capsule of 250 mg A3384 + 3 placebo capsules ) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    1 g A3384
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (i.e. one dosage unit = 4 capsules of 250 mg A3384) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients received a treatment pack containing 136 capsules (for treatment of 17 days). Four capsules (4 placebo capsules, i.e. one dosage unit) were taken twice daily orally with water, 30 minutes before breakfast and 30 minutes before supper at approximately 5 to 8 pm.

    Serious adverse events
    		 250 mg A3384 1 g A3384 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    skeletal metastases
    Additional description: Skeletal metastases in spine, unknown primary tumor. Was judged to be not related to the study drug and was classified as post study event
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (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: 0%
    Non-serious adverse events
    		 250 mg A3384 1 g A3384 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    5 / 7 (71.43%)
    6 / 6 (100.00%)
    Investigations
    Increased value pf P-Calcium
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Heart palpitations
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Rhizophathia right arm
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Stomach pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Sweating
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Shoulder pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Chest infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Common cold
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2014
    Amendment No. 2 Sweden Substantial Amendment to the Investigational Medicinal Product Dossier, Change in widen of specification for assay from 90-100% to 80-120% to enable the recently manufactured capsules to be used in the study
    15 Jul 2014
    Amendment No. 2 UK Substantial Amendment to the Investigational Medicinal Product Dossier, Change in widen of specification for assay from 90-100% to 80-120% to enable the recently manufactured capsules to be used in the study

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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