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    Clinical Trial Results:
    A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation.

    Summary
    EudraCT number
    2016-002837-31
    Trial protocol
    IE   GB   DE   BE   CZ  
    Global end of trial date
    24 Aug 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG2222-CL-201
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03045523
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Industriepark Mechelen Noord Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical trial information desk, Galapagos NV, +32 15 342 900 , rd@glpg.com
    Scientific contact
    Clinical trial information desk, Galapagos NV, +32 15 342 900 , rd@glpg.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: - To evaluate the safety and tolerability of two doses of orally administered GLPG2222 in ivacaftor-treated adult subjects with CF harboring one F508del CFTR mutation and a second gating (Class III) mutation. Secondary Objectives: - To assess changes in sweat chloride as a biomarker of CFTR ion channel function. - To assess changes in pulmonary function (forced expiratory volume in 1 second [FEV1]). - To assess changes in the Respiratory Domain of the Cystic Fibrosis Questionnaire – Revised (CFQ-R).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95) and with applicable local requirements. Prior to the performance of any study-specific procedure, written informed consent was obtained from each subject. He or she was informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that participation was voluntary and that he or she could withdraw from the study at any time for any reason and that this would not have any effect on his or her potential future medical care.
    Background therapy
    Ivacaftor (Kalydeco) 150 mg twice daily (b.i.d.)
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jan 2017
    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
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Ireland: 8
    Country: Number of subjects enrolled
    Australia: 5
    Worldwide total number of subjects
    37
    EEA total number of subjects
    32
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 23-Jan-2017 (date the first subject signed the ICF) to 24-Aug-2017 (date of last contact with last subject). The last visit of last subject occurred on 11-Aug-2017. Subjects were effectively enrolled in sites located in Australia(4), Belgium (3), Czech Republic (1), Germany (3), United Kingdom (7), and Ireland (3).

    Pre-assignment
    Screening details
    In total, 47 subjects were screened, 37 of which were enrolled and treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GLPG2222 - 150 mg q.d.
    Arm description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)
    Arm type
    Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    A dose of 150 mg GLPG2222 corresponding to 3.0 mL of the oral suspension containing 50 mg G957389/mL was administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days. GLPG2222 was presented as a ready-to-use oral suspension, containing 50 or 100 mg G957389/mL (G957389 is the compound code for GLPG2222).

    Arm title
    GLPG2222 - 300 mg q.d.
    Arm description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)
    Arm type
    Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    A dose of 300 mg GLPG2222 corresponding to 3.0 mL of the oral suspension containing 100 mg G957389/mL was administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days. GLPG2222 was presented as a ready-to-use oral suspension, containing 50 or 100 mg G957389/mL.

    Arm title
    Placebo q.d.
    Arm description
    Placebo to match was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match corresponding to 3.0 mL of the oral suspension was administered daily.

    Number of subjects in period 1
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Started
    16
    14
    7
    Completed
    15
    13
    7
    Not completed
    1
    1
    0
         Wrong study drug kit provided
    1
    -
    -
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG2222 - 150 mg q.d.
    Reporting group description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Reporting group title
    GLPG2222 - 300 mg q.d.
    Reporting group description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Reporting group title
    Placebo q.d.
    Reporting group description
    Placebo to match was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Reporting group values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d. Total
    Number of subjects
    16 14 7 37
    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)
    16 14 7 37
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    29 (19 to 42) 29 (18 to 35) 46 (19 to 53) -
    Gender categorical
    Units: Subjects
        Female
    4 8 4 16
        Male
    12 6 3 21
    Race
    Units: Subjects
        White
    16 14 7 37
    BMI
    Units: kg/m2
        median (full range (min-max))
    23.95 (19.9 to 31.5) 22.00 (18.4 to 34.3) 25.30 (21.2 to 33.6) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG2222 - 150 mg q.d.
    Reporting group description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Reporting group title
    GLPG2222 - 300 mg q.d.
    Reporting group description
    GLPG2222 was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Reporting group title
    Placebo q.d.
    Reporting group description
    Placebo to match was administered in addition to a stable ivacaftor regimen (150 mg b.i.d.)

    Primary: Safety - TEAE (Treatment-Emergent Adverse Events)

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    End point title
    Safety - TEAE (Treatment-Emergent Adverse Events) [1]
    End point description
    The number of subjects with treatment-emergent adverse events (TEAEs). An analysis of the TEAEs was performed. Laboratory assessments, 12-lead ECG, vital signs, physical examinations, oxygen saturation by pulse oximetry and spirometry were analyzed descriptively.
    End point type
    Primary
    End point timeframe
    From first study drug administration until the last follow-up visit.
    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: Descriptive analysis only.
    End point values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Number of subjects analysed
    16
    14
    7
    Units: Subjects
        Any TEAE
    12
    13
    7
        Severe TEAE
    1
    0
    0
        Serious TEAE
    0
    0
    0
        Treatment related TEAE
    4
    8
    5
        Discontinuation due to AE
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Sweat Chloride Concentration by treatment group

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    End point title
    Sweat Chloride Concentration by treatment group
    End point description
    The statistical evaluation of the mean sweat chloride concentration changes from baseline per time point for the modified ITT (intent to treat) Population, based on the arm with the greatest volume.
    End point type
    Secondary
    End point timeframe
    Sweat was collected at screening and pre-dose on Days 1, 15 and 29, early discontinuation (if applicable) and follow-up.
    End point values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Number of subjects analysed
    15
    14
    7
    Units: mmol/L
    arithmetic mean (standard error)
        Baseline
    45.8 ± 5.21
    52.2 ± 6.45
    43.1 ± 9.23
        Day 15
    -2.8 ± 3.57
    -6.3 ± 3.31
    1.0 ± 5.37
        Day 29
    -2.5 ± 3.09
    -6.5 ± 2.97
    6.3 ± 5.78
    No statistical analyses for this end point

    Secondary: Pulmonary function by treatment group (mean absolute FEV1)

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    End point title
    Pulmonary function by treatment group (mean absolute FEV1)
    End point description
    The statistical evaluation of the mean FEV1 changes from baseline per time point for the modified ITT population.
    End point type
    Secondary
    End point timeframe
    Between screening and pre-dose on Days 1, 15 and 29, early discontinuation (if applicable) and follow-up.
    End point values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Number of subjects analysed
    15
    14
    7
    Units: Liter
    arithmetic mean (standard error)
        Baseline
    3.029 ± 0.2450
    2.385 ± 0.2452
    2.637 ± 0.4390
        Day 15
    0.097 ± 0.0576
    0.096 ± 0.0288
    0.060 ± 0.0548
        Day 29
    -0.008 ± 0.0605
    0.076 ± 0.0295
    -0.023 ± 0.0378
    No statistical analyses for this end point

    Secondary: Pulmonary function by treatment group (ppFEV1)

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    End point title
    Pulmonary function by treatment group (ppFEV1)
    End point description
    The statistical evaluation of the mean percent predicted forced expiratory volume in 1 second (ppFEV1) changes from baseline per time point.
    End point type
    Secondary
    End point timeframe
    Between screening and pre-dose on Days 1, 15 and 29, early discontinuation (if applicable) and follow-up.
    End point values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Number of subjects analysed
    15
    14
    7
    Units: Liter
    arithmetic mean (standard error)
        Baseline
    71.0 ± 8.01
    72.2 ± 4.40
    62.9 ± 4.77
        Day 15
    2.0 ± 1.65
    2.3 ± 1.39
    2.6 ± 0.87
        Day 29
    -0.7 ± 1.11
    -0.5 ± 1.58
    1.9 ± 0.95
    No statistical analyses for this end point

    Secondary: Cystic Fibrosis Questionnaire revised respiratory domain (CFQ-R)

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    End point title
    Cystic Fibrosis Questionnaire revised respiratory domain (CFQ-R)
    End point description
    The statistical evaluation of the mean CFQ-R Respiratory domain score changes from baseline per time point for modified ITT population.
    End point type
    Secondary
    End point timeframe
    Eligible subjects were asked to complete the adult version of the CFQ-R at screening, Days 1, 15 and 29, early discontinuation (if applicable) and follow-up.
    End point values
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Number of subjects analysed
    15
    14
    7
    Units: percentage
    arithmetic mean (standard error)
        Baseline
    79.6 ± 5.22
    81.3 ± 3.17
    81.7 ± 6.50
        Day 15
    3.3 ± 1.78
    1.6 ± 2.13
    1.4 ± 0.91
        Day 29
    1.9 ± 2.08
    2.4 ± 2.08
    1.4 ± 2.29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE: from the signature of ICF until the final follow-up visit. TEAE: from first study drug administration until the final follow-up visit.
    Adverse event reporting additional description
    No deaths, serious adverse events or TEAEs leading to study drug discontinuation were reported during the study. Twelve (12) Treatment-emergent AEs were considered related to the study drug by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    GLPG2222 - 150 mg q.d.
    Reporting group description
    -

    Reporting group title
    GLPG2222 - 300 mg q.d.
    Reporting group description
    -

    Reporting group title
    Placebo q.d.
    Reporting group description
    -

    Serious adverse events
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    GLPG2222 - 150 mg q.d. GLPG2222 - 300 mg q.d. Placebo q.d.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 16 (75.00%)
    13 / 14 (92.86%)
    7 / 7 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 16 (12.50%)
    4 / 14 (28.57%)
    0 / 7 (0.00%)
         occurrences all number
    3
    4
    0
    Chest discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Chest pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Chills
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    3
    2
    1
    Cough
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    2
    2
    1
    Sputum increased
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    1
    Haemoptysis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    7
    1
    Dyspnoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    0
    Hypoventilation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal polyps
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Painful respiration
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    Productive cough
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Emotional disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Blood glucose decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Glucose urine
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Glucose urine present
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Cystic fibrosis related diabetes
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    sinus arrhytmia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 16 (18.75%)
    7 / 14 (50.00%)
    2 / 7 (28.57%)
         occurrences all number
    6
    13
    2
    Paraesthesia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 16 (31.25%)
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    5
    4
    1
    Abdominal pain
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    2
    5
    0
    Nausea
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    3
    0
    Constipation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    2 / 7 (28.57%)
         occurrences all number
    0
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Faeces soft
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    Flatulence
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Steatorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Neck pain
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Metatarsalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle twitching
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    1
    Rhinitis
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    3
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0

    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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    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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