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    Clinical Trial Results:
    A phase IIa, double-blind, randomised, placebo-controlled, dose-finding study on the efficacy and tolerability of a 6-week treatment with ZED1227 capsules vs. placebo in subjects with well-controlled celiac disease undergoing gluten challenge

    Summary
    EudraCT number
    2017-002241-30
    Trial protocol
    LT   FI   DE   AT   IE  
    Global end of trial date
    27 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jul 2021
    First version publication date
    17 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CEC-3/CEL
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dr. Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, D-79108
    Public contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, +49 761 1514 -0, zentrale@drfalkpharma.de
    Scientific contact
    Department of Clinical Research, Dr. Falk Pharma GmbH, +49 761 1514 -0, zentrale@drfalkpharma.de
    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
    21 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to assess the efficacy of 3 different doses of ZED1227 capsules for prevention of gluten-induced mucosal changes in subjects with well-controlled celiac disease undergoing gluten challenge.
    Protection of trial subjects
    Close supervision of subjects by implementing interim visits every 14 days up to week 6 and one follow up vist at week 10 to guarantee their safety and wellbeing. Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial.
    Background therapy
    None.
    Evidence for comparator
    As there is no standard therapy, placebo was used as comparator.
    Actual start date of recruitment
    16 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 29
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Finland: 39
    Country: Number of subjects enrolled
    Germany: 77
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Lithuania: 8
    Country: Number of subjects enrolled
    Switzerland: 5
    Worldwide total number of subjects
    163
    EEA total number of subjects
    158
    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)
    163
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    In total 163 patients were included in Estonia, Finland, Germany, Ireland, Lithuania, Norway and Switzerland from May 2018 to February 2020.

    Pre-assignment
    Screening details
    Screening Criteria: 1. Signed Informed Consent 2. Aged 18 to 64 years 3. Active Celiac Disease. In total, 249 patients were screened. Thereof 163 patients were randomised, 159 patients were treated and included in the intention-to-treat analysis set. n=3 no study medication dispensed. n=1 medication administration uncertain.

    Period 1
    Period 1 title
    Treatment Phase (overall trial) (overall period)
    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
    Arm A
    Arm description
    One 10 mg ZED1227 capsule in the morning.
    Arm type
    Experimental

    Investigational medicinal product name
    10 mg ZED1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg ZED1227 capsule in the morning in fasted state.

    Arm title
    Arm B
    Arm description
    One 50 mg ZED1227 capsule in the morning.
    Arm type
    Experimental

    Investigational medicinal product name
    50 mg ZED1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 50 mg ZED1227 capsule in the morning in a fasted state.

    Arm title
    Arm C
    Arm description
    One 100 mg ZED1227 capsule in the morning.
    Arm type
    Experimental

    Investigational medicinal product name
    100 mg ZED1227
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 100 mg ZED1227 capsule in the morning in fasted state.

    Arm title
    Arm D
    Arm description
    One placebo ZED1227 capsule in the morning.
    Arm type
    Placebo

    Investigational medicinal product name
    ZED1227 placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo ZED1227 capsule in the morning in fasted state.

    Number of subjects in period 1 [1]
    Arm A Arm B Arm C Arm D
    Started
    41
    41
    39
    38
    Completed
    33
    39
    37
    30
    Not completed
    8
    2
    2
    8
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    8
    2
    2
    7
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: n=3 no study medication dispensed because of the development of other clinical condition. n=1 lost to follow-up, medication administration uncertain, safety data incompletely available (included in safety analysis set only)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Phase (overall trial)
    Reporting group description
    163 patients were finally randomised in one of the four treatment groups. 3 patients have been randomised but not treated. 1 patient was lost to follow-up, treatment uncertain (included in safety set only).

    Reporting group values
    Treatment Phase (overall trial) Total
    Number of subjects
    159 159
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    159 159
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.6 ± 13.4 -
    Gender categorical
    Subjects of both sex were recruited in this trial.
    Units: Subjects
        Female
    118 118
        Male
    41 41

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    One 10 mg ZED1227 capsule in the morning.

    Reporting group title
    Arm B
    Reporting group description
    One 50 mg ZED1227 capsule in the morning.

    Reporting group title
    Arm C
    Reporting group description
    One 100 mg ZED1227 capsule in the morning.

    Reporting group title
    Arm D
    Reporting group description
    One placebo ZED1227 capsule in the morning.

    Primary: Attenuation of gluten-induced mucosal damage

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    End point title
    Attenuation of gluten-induced mucosal damage
    End point description
    As stipulated in the trial protocol, the primary end-point analysis included all the patients who underwent randomization and had villus height and crypt depth measurements from at least three separate villus–crypt units of sufficient quality in total from the duodenum biopsies available at both the baseline (screening) visit and the final or withdrawal visit (142 patients).
    End point type
    Primary
    End point timeframe
    Within 6 weeks starting with baselines/ randomisation to Final Visit (week 6).
    End point values
    Arm A Arm B Arm C Arm D
    Number of subjects analysed
    35
    39
    38
    30
    Units: Ratio of Villus Height to Crypt Depth
        least squares mean (confidence interval 95%)
    -0.17 (-0.33 to -0.01)
    -0.12 (-0.27 to 0.03)
    -0.13 (-0.28 to 0.03)
    -0.61 (-0.78 to -0.44)
    Statistical analysis title
    Primary analysis
    Comparison groups
    Arm A v Arm D
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Generalized linear model (GLM)
    Parameter type
    Mean difference (final values)
    Point estimate
    0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.15
         upper limit
    0.73
    Statistical analysis title
    Primary analysis
    Comparison groups
    Arm B v Arm D
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Generalized linear model
    Parameter type
    Mean difference (final values)
    Point estimate
    0.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.77
    Statistical analysis title
    Primary analysis
    Comparison groups
    Arm C v Arm D
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Generalized linear model
    Parameter type
    Mean difference (final values)
    Point estimate
    0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.77

    Secondary: Intraepithelial lymphocyte density

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    End point title
    Intraepithelial lymphocyte density
    End point description
    End point type
    Secondary
    End point timeframe
    Within 6 weeks starting with baselines/ randomisation to Final Visit (week 6).
    End point values
    Arm A Arm B Arm C Arm D
    Number of subjects analysed
    35
    39
    38
    31
    Units: No. of cells per 100 epithelial cells
        least squares mean (confidence interval 95%)
    8.3 (5.0 to 11.7)
    6.9 (3.7 to 10.1)
    1.5 (-1.8 to 4.7)
    11.0 (7.4 to 14.6)
    Statistical analysis title
    Secondary analysis
    Comparison groups
    Arm A v Arm D
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.6
         upper limit
    2.2
    Statistical analysis title
    Secondary analysis
    Comparison groups
    Arm B v Arm D
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.9
         upper limit
    0.6
    Statistical analysis title
    Secondary analysis
    Comparison groups
    Arm C v Arm D
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -9.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.4
         upper limit
    -4.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were assessed at all interim visits (week 2, week 4 and week 6 and at the Follow up visit week 10).
    Adverse event reporting additional description
    Treatment-Emergent Adverse Events
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    One 10 mg ZED1227 capsule in the morning in fasted state.

    Reporting group title
    Arm B
    Reporting group description
    One 50 mg ZED1227 capsule in the morning in fasted state.

    Reporting group title
    Arm C
    Reporting group description
    One 100 mg ZED1227 capsule in the morning in fasted state.

    Reporting group title
    Arm D
    Reporting group description
    One Placebo ZED1227 capsule in the morning in fasted state.

    Serious adverse events
    Arm A Arm B Arm C Arm D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Ventricular extrasystoles
    Additional description: SAE considered to be related to study treatment, patient discontinued trial.
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine with aura
    Additional description: SAE considered to be study related, patient discontinued the trial.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm A Arm B Arm C Arm D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 41 (80.49%)
    30 / 41 (73.17%)
    32 / 40 (80.00%)
    30 / 38 (78.95%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 41 (4.88%)
    6 / 41 (14.63%)
    2 / 40 (5.00%)
    3 / 38 (7.89%)
         occurrences all number
    2
    6
    2
    4
    Influenza
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    0
    1
    Investigations
    Blood folate decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Blood zinc decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Transferrin saturation decreased
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
         occurrences all number
    3
    1
    2
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 41 (21.95%)
    13 / 41 (31.71%)
    10 / 40 (25.00%)
    13 / 38 (34.21%)
         occurrences all number
    10
    14
    14
    17
    Migraine
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    0
    2
    Migraine with aura
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Vertigo
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    1
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    1
    3
    Abdominal distension
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    4 / 40 (10.00%)
    3 / 38 (7.89%)
         occurrences all number
    2
    4
    4
    3
    Abdominal pain
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 41 (12.20%)
    5 / 40 (12.50%)
    3 / 38 (7.89%)
         occurrences all number
    3
    7
    5
    4
    Abdominal pain lower
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    3 / 40 (7.50%)
    3 / 38 (7.89%)
         occurrences all number
    2
    2
    3
    3
    Aphthous ulcer
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    1 / 38 (2.63%)
         occurrences all number
    2
    3
    1
    1
    Diarrhoea
         subjects affected / exposed
    4 / 41 (9.76%)
    5 / 41 (12.20%)
    6 / 40 (15.00%)
    4 / 38 (10.53%)
         occurrences all number
    4
    6
    9
    4
    Dyspepsia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    3 / 38 (7.89%)
         occurrences all number
    1
    2
    2
    3
    Eructation
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    1
    1
    Flatulence
         subjects affected / exposed
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    1 / 40 (2.50%)
    3 / 38 (7.89%)
         occurrences all number
    3
    4
    1
    3
    Nausea
         subjects affected / exposed
    6 / 41 (14.63%)
    7 / 41 (17.07%)
    4 / 40 (10.00%)
    7 / 38 (18.42%)
         occurrences all number
    6
    8
    4
    7
    Regurgitation
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    8 / 38 (21.05%)
         occurrences all number
    4
    3
    1
    8
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    3 / 40 (7.50%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    2
    2
    Back pain
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Influenza
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    4 / 40 (10.00%)
    4 / 38 (10.53%)
         occurrences all number
    2
    4
    4
    5
    Rhinitis
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2018
    Amendment 01 (globally amendment dated 08.03.2018) forming Integrated Protocol Version 2.0/08.03.2018
    20 Dec 2018
    Amendment 02 (global amendment dated 20.12.2018) forming Integrated Protocol Version 3.0/20.12.2018

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/34192430
    http://www.ncbi.nlm.nih.gov/pubmed/34192435
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