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    Clinical Trial Results:
    Ferrous Acetyl-Aspartylated Casein Formulation Evaluation over Ferrous Sulfate in Iron Deficiency Anemia (Access): A Double-Dummy Randomized Clinical Trial

    Summary
    EudraCT number
    		 2017-002972-15
    Trial protocol
    		 GR  
    Global end of trial date
    08 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Omalin-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03524651
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
    Sponsor organisation address
    14th Km National Road 1, Kifissia, Greece, 14564
    Public contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 30 2108072512374, soumelas@uni-pharma.gr
    Scientific contact
    Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A., 30 2108072512374, soumelas@uni-pharma.gr
    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
    10 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with IDA for the restoration of decreased circulating Hb.
    Protection of trial subjects
    Νo specific measures applied
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2018
    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
    Greece: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    26
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first patient was admitted to the study on 01.04.2018 and the last on 08.01.2021. A total of n = 60 patients were recruited, who completed the study in 1 center: 4th Department of Internal Medicine ATTIKON University General Hospital, National and Kapodistrian University of Athens, Medical School, Greece.

    Pre-assignment
    Screening details
    		 From 387 patients screened for eligibility, 60 patients (30 per group) were randomized and 327 were excluded. The majority of them (125) were excluded because of RBC count over the limit set. 1 and 5 patients respectively withdrew consent and request removal of data leaving 29 and 25 patients respectively for the analysis of the primary endpoint.

    Period 1
    Period 1 title
    Visit 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Patients were randomly 1:1 assigned to double-blind and double-dummy treatment with FeSO4 or Fe-ASP. Randomization was provided by a sealed envelope to the investigators. Investigator and patient were blind to the allocated intervention. Following randomization, every patient was delivered two different boxes, one for each month of treatment. The first box contained capsules with a three-digit number at the outside. The second box contained vials with a four-digit number at the outside.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferrous sulfate
    Arm description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Microfer
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin placebo
    Investigational medicinal product code
    Other name
    Fe-ASP placebo
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin.

    Arm title
    		 Fe-ASP
    Arm description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Microfer placebo
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin
    Investigational medicinal product code
    Other name
    Fe-ASP vials
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Number of subjects in period 1
    		Ferrous sulfate Fe-ASP
    Started
    29
    25
    Completed
    29
    25
    Period 2
    Period 2 title
    Visit 2 -4 weeks after start
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    As per baseline period

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferrous sulfate
    Arm description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Microfer
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin placebo
    Investigational medicinal product code
    Other name
    Fe-ASP placebo
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin.

    Arm title
    		 Fe-ASP
    Arm description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Microfer placebo
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin
    Investigational medicinal product code
    Other name
    Fe-ASP vials
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Number of subjects in period 2
    		Ferrous sulfate Fe-ASP
    Started
    29
    25
    Completed
    29
    25
    Period 3
    Period 3 title
    Visit 2 -12 weeks after start
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    As per baseline period

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferrous sulfate
    Arm description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Microfer
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin placebo
    Investigational medicinal product code
    Other name
    Fe-ASP placebo
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin.

    Arm title
    		 Fe-ASP
    Arm description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Microfer placebo
    Investigational medicinal product code
    Other name
    Ferrous sulfate capsules placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal.

    Investigational medicinal product name
    Omalin
    Investigational medicinal product code
    Other name
    Fe-ASP vials
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Number of subjects in period 3
    		Ferrous sulfate Fe-ASP
    Started
    29
    25
    Completed
    18
    15
    Not completed
    11
    10
         Lost to follow-up
    11
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ferrous sulfate
    Reporting group description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).

    Reporting group title
    Fe-ASP
    Reporting group description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Reporting group values
    		 Ferrous sulfate Fe-ASP Total
    Number of subjects
    		 29 25 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 11 26
        From 65-84 years
    		 14 14 28
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ± 16.1 62.7 ± 21.2 -
    Gender categorical
    Units: Subjects
        Female
    		 19 14 33
        Male
    		 10 11 21

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Ferrous sulfate
    Reporting group description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).

    Reporting group title
    Fe-ASP
    Reporting group description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.
    Reporting group title
    Ferrous sulfate
    Reporting group description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).

    Reporting group title
    Fe-ASP
    Reporting group description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.
    Reporting group title
    Ferrous sulfate
    Reporting group description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).

    Reporting group title
    Fe-ASP
    Reporting group description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Primary: Absolute change of baseline Hb

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    End point title
    		 Absolute change of baseline Hb [1]
    End point description
    The primary study endpoint was the non-inferiority of the increase of baseline Hb in the FeSO4 and in the Fe-ASP group after the first 4 weeks of treatment. Since the daily amount of elementary iron delivered with the ferrous sulfate regimen was 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb was adjusted per mg of delivered elementary iron.
    End point type
    Primary
    End point timeframe
    Αfter the first 4 weeks of treatment
    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: N/A
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: gram/dl
        arithmetic mean (standard error)
    0.76 ± 0.27
    0.83 ± 0.31
    No statistical analyses for this end point

    Primary: Relative % change of baseline Hb

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    End point title
    		 Relative % change of baseline Hb [2]
    End point description
    The primary study endpoint was the non-inferiority of the increase of baseline Hb in the FeSO4 and in the Fe-ASP group after the first 4 weeks of treatment. Since the daily amount of elementary iron delivered with the ferrous sulfate regimen was 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb was adjusted per mg of delivered elementary iron.
    End point type
    Primary
    End point timeframe
    After the first 4 weeks of treatment
    Notes
    [2] - 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: N/A
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: percent change
        arithmetic mean (standard error)
    10.3 ± 3.51
    10.99 ± 4.03
    No statistical analyses for this end point

    Secondary: Absolute change of absolute RBC count from baseline

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    End point title
    		 Absolute change of absolute RBC count from baseline
    End point description
    Absolute change of the absolute red blood cell (RBC) count from baseline. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, all secondary study endpoints were adjusted per mg of delivered elemental iron.
    End point type
    Secondary
    End point timeframe
    After 4 weeks
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: cells
        arithmetic mean (standard error)
    0.23 ± 0.07
    0.37 ± 0.13
    No statistical analyses for this end point

    Secondary: Relative % change of absolute RBC count from baseline

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    End point title
    		 Relative % change of absolute RBC count from baseline
    End point description
    Relative change of the absolute red blood cell (RBC) count from baseline. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, all secondary study endpoints were adjusted per mg of delivered elemental iron.
    End point type
    Secondary
    End point timeframe
    After 4 weeks
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: percent change
        arithmetic mean (standard error)
    6.61 ± 2.08
    13.65 ± 5.61
    No statistical analyses for this end point

    Secondary: Absolute change of the absolute reticulocyte count from baseline

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    End point title
    		 Absolute change of the absolute reticulocyte count from baseline
    End point description
    Absolute change of the absolute reticulocyte count from baseline. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, all secondary study endpoints were adjusted per mg of delivered elemental iron.
    End point type
    Secondary
    End point timeframe
    After 4 weeks
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: cells
        arithmetic mean (standard error)
    -43.7 ± 131.2
    116 ± 80.2
    No statistical analyses for this end point

    Secondary: Relative % change of the absolute reticulocyte count from baseline

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    End point title
    		 Relative % change of the absolute reticulocyte count from baseline
    End point description
    Relative change of the absolute reticulocyte count from baseline. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, all secondary study endpoints were adjusted per mg of delivered elemental iron.
    End point type
    Secondary
    End point timeframe
    After 4 weeks
    End point values
    		 Ferrous sulfate Fe-ASP
    Number of subjects analysed
    29
    25
    Units: percent
        arithmetic mean (standard error)
    -3.9 ± 5.9
    11.8 ± 6.21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Ferrous sulfate
    Reporting group description
    		 Patients were taken every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elementary iron. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were also taking every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-ASP Omalin (Uni-Pharma SA).

    Reporting group title
    Fe-ASP
    Reporting group description
    		 Patients were taking every day for 12 weeks two oral placebo capsules. The capsules were containing the inactive excipients of Microfer. Patients were instructed to receive the capsules either two hours before meal or two hours after meal. The same patients were taking every day on the same time for 12 weeks two vials of 15 ml volume the Fe-ASP preparation Omalin (Uni-Pharma SA) delivering 40 mg of elementary iron.

    Serious adverse events
    		 Ferrous sulfate Fe-ASP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 29 (17.24%)
    6 / 25 (24.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Hospital admission due to abdominal pain
         subjects affected / exposed
    5 / 29 (17.24%)
    6 / 25 (24.00%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ferrous sulfate Fe-ASP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 29 (17.24%)
    7 / 25 (28.00%)
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Helicobacter gastritis
    Additional description: Helicobacter pylori gastritis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Fungal oesophagitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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