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    Clinical Trial Results:
    The efficacy and safety of erdosteine in the long-term therapy of chronic obstructive pulmonary disease (COPD). A 12-month, randomised, double-blind, placebo-controlled, parallel group, multicenter study.

    Summary
    EudraCT number
    2008-008192-34
    Trial protocol
    IT   GB   CZ   FR   DK   SK   BE   BG  
    Global end of trial date
    15 Feb 2013

    Results information
    Results version number
    v1
    This version publication date
    13 Nov 2016
    First version publication date
    13 Nov 2016
    Other versions
    v2 , v3
    Summary report(s)
    Study Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    ERD-01-08/EP
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01032304
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Edmond Pharma Srl
    Sponsor organisation address
    via F. Serpero 2, Masate (Mi), Italy, 20060
    Public contact
    Pozzi Edoardo, Edmond Pharma, +39 029500461, edoardo.pozzi@recipharm.com
    Scientific contact
    Pozzi Edoardo , Edmond Pharma, +39 029500461, edoardo.pozzi@recipharm.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 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective of the study is to evaluate if erdosteine is effective in reducing the risk of acute exacerbations in patients affected by moderate-to-severe COPD during a 12-month treatment period.
    Protection of trial subjects
    The efficacy of erdosteine has been evaluated using the experimental drug as add-on to a regular maintenance therapy of COPD. Patients continued their standard treatment for COPD, established by the physician according to the best clinical practice and guidelines. Since patients, in any case, receive the appropriate COPD standard treatment, the administration of placebo to half of them do not posed particular ethical concerns, while being at the same time scientifically sounded in order to establish the additional benefits of adding erdosteine to regular maintenance COPD treatment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Nov 2009
    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
    Slovakia: 11
    Country: Number of subjects enrolled
    United Kingdom: 22
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Bulgaria: 14
    Country: Number of subjects enrolled
    Czech Republic: 100
    Country: Number of subjects enrolled
    Denmark: 16
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Italy: 109
    Country: Number of subjects enrolled
    Poland: 114
    Country: Number of subjects enrolled
    Romania: 126
    Worldwide total number of subjects
    528
    EEA total number of subjects
    528
    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)
    254
    From 65 to 84 years
    274
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First patient in 02-11-2009; last patient in 15/02/2013 . Countries involved: Italy, United Kingdom, Denmark, Czech Republic, France, Poland, Romania, Moldvia, Bulgaria.

    Pre-assignment
    Screening details
    Outpatients of both sexes, aged between 40 and 80 years with diagnosis of COPD (Stage II and III according to GOLD 2007); with a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion, 61 screening failure were registered due to consent withdrown or lost to visit 1

    Pre-assignment period milestones
    Number of subjects started
    528
    Number of subjects completed
    467

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Physician decision: 61
    Period 1
    Period 1 title
    overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Active
    Arm description
    blinded capsules erdosteine 300 mg
    Arm type
    Experimental

    Investigational medicinal product name
    erdosteine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg BID

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    erdosteine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg BID

    Number of subjects in period 1 [1]
    Active Placebo
    Started
    228
    239
    Completed
    203
    213
    Not completed
    25
    26
         Adverse event, serious fatal
    1
    2
         Adverse event, non-fatal
    10
    4
         Consent withdrawn by subject
    14
    20
    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: 61 patients were considered as "screening failure" before the therapy assignement

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall period
    Reporting group description
    -

    Reporting group values
    overall period Total
    Number of subjects
    467 467
    Age categorical
    patient aged between 40 and 80 years
    Units: Subjects
        40-80 yrs
    467 467
    Age continuous
    Units: years
        median (standard deviation)
    64.769 ± 8.34 -
    Gender categorical
    Units: Subjects
        Female
    122 122
        Male
    345 345
    Population characteristic
    Units: Subjects
        COPD
    467 467

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    blinded capsules erdosteine 300 mg

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Primary: overall number of exacerbations

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    End point title
    overall number of exacerbations
    End point description
    End point type
    Primary
    End point timeframe
    treatment period
    End point values
    Active Placebo
    Number of subjects analysed
    228
    239
    Units: exact number
        exacerbations
    196
    261
    Statistical analysis title
    overall exacerbations rate
    Statistical analysis description
    A predefined analysis of exacerbation frequency was performed using a Poisson regression model, with the covariates of treatment, age, sex, Body Mass Index, and FEV1 at the baseline to estimate the rate ratio. The natural logarithm of the duration, expressed as months in the study, was used as an offset variable to correct for differences in the time individuals spent under observation.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    467
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    Wilcoxon (Mann-Whitney)
    Parameter type
    Poisson regression estimate
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    treatment duration 12 mounths
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    erdosteine
    Reporting group description
    -

    Reporting group title
    placebo
    Reporting group description
    -

    Serious adverse events
    erdosteine placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    41 / 228 (17.98%)
    33 / 239 (13.81%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Vascular disorders
    transient cerebrovascular insufficency
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    carbonon monoxide poisoning
    alternative dictionary used: MedDRA 17.1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    laringoscopy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heart failure
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COPD exacerbation
         subjects affected / exposed
    20 / 228 (8.77%)
    16 / 239 (6.69%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 228 (1.75%)
    3 / 239 (1.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    chest/epigastric pain
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    cancer
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystectomy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    vertebral pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    erdosteine placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    228 / 228 (100.00%)
    206 / 239 (86.19%)
    Surgical and medical procedures
    Infiltration anaesthesia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Liver function test abnormal
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 239 (0.84%)
         occurrences all number
    1
    2
    Chills
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 239 (0.00%)
         occurrences all number
    2
    0
    Asthenia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Haemoptysis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    0 / 228 (0.00%)
    5 / 239 (2.09%)
         occurrences all number
    0
    5
    Insomnia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 239 (0.84%)
         occurrences all number
    0
    3
    Tooth abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    2
    1
    Toothache
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    2
    Weight decreased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Investigations
    Mitral valve replacement
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    1
    1
    Cardiac disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 239 (0.84%)
         occurrences all number
    0
    2
    Arrhythmia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Coronary artery disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    8 / 228 (3.51%)
    1 / 239 (0.42%)
         occurrences all number
    9
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    1
    1
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Viral infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 239 (1.26%)
         occurrences all number
    5
    5
    Chest pain
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 239 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    2 / 228 (0.88%)
    3 / 239 (1.26%)
         occurrences all number
    2
    3
    Throat irritation
         subjects affected / exposed
    1 / 228 (0.44%)
    4 / 239 (1.67%)
         occurrences all number
    1
    4
    Dyspnoea
         subjects affected / exposed
    3 / 228 (1.32%)
    10 / 239 (4.18%)
         occurrences all number
    3
    11
    Sputum discoloured
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Painful respiration
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    COPD exacerbations
         subjects affected / exposed
    99 / 228 (43.42%)
    136 / 239 (56.90%)
         occurrences all number
    185
    258
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Anaemia folate deficiency
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Arterial disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Anxiety
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 239 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    2
    0
    Corneal abrasion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 228 (1.75%)
    3 / 239 (1.26%)
         occurrences all number
    4
    3
    Reflux gastritis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 239 (0.42%)
         occurrences all number
    3
    1
    Dyspepsia
         subjects affected / exposed
    1 / 228 (0.44%)
    6 / 239 (2.51%)
         occurrences all number
    1
    6
    Gastric ulcer
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 239 (0.00%)
         occurrences all number
    2
    0
    Acidosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    1
    1
    Urinary tract inflammation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 228 (1.75%)
    1 / 239 (0.42%)
         occurrences all number
    4
    0
    Incontinence
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Bladder spasm
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 239 (1.26%)
         occurrences all number
    3
    3
    Contusion
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Bite
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Fibromyalgia
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 239 (0.84%)
         occurrences all number
    1
    2
    Joint abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 239 (0.42%)
         occurrences all number
    2
    1
    Oedema
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 239 (0.42%)
         occurrences all number
    0
    0
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 239 (0.42%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Hyper HDL cholesterolaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Cachexia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 239 (1.26%)
         occurrences all number
    3
    3
    Pyrexia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Mycobacterial infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 239 (0.84%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences all number
    2
    1
    Viraemia
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 239 (0.84%)
         occurrences all number
    1
    2

    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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