Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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
    03 Feb 2014

    Results information
    Results version number
    		 v3(current)
    This version publication date
    09 Feb 2017
    First version publication date
    13 Nov 2016
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    Safety data revision/others data correction
    Summary report(s)
    		 Study Synopsis

    Trial information

    		 Close Top of page
    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
    S.S. dei Giovi 131, Paderno Dugnano (Mi), Italy, 20037
    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
    03 Feb 2014
    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
    United Kingdom: 9
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Czech Republic: 96
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Italy: 94
    Country: Number of subjects enrolled
    Romania: 119
    Country: Number of subjects enrolled
    Poland: 101
    Country: Number of subjects enrolled
    Slovakia: 11
    Worldwide total number of subjects
    467
    EEA total number of subjects
    467
    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)
    224
    From 65 to 84 years
    243
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    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, Bulgaria, Slovakia and Belgium.

    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
    		 467
    Number of subjects completed
    		 467

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active
    Arm description
    		 erdosteine cps 300 mg BID
    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 controlled
    Arm type
    		 Placebo

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

    Number of subjects in period 1
    		active placebo
    Started
    228
    239
    Completed
    203
    213
    Not completed
    25
    26
         Adverse event, serious fatal
    1
    2
         Consent withdrawn by subject
    14
    20
         Adverse event, non-fatal
    10
    4

    Baseline characteristics

    		 Close Top of page
    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
        randomised
    		 467 467
        not recorded
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 64.8 ± 8.34 -
    Gender categorical
    Units: Subjects
        Female
    		 122 122
        Male
    		 345 345
    Population characteristic
    Units: Subjects
        COPD
    		 467 467

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    active
    Reporting group description
    		 erdosteine cps 300 mg BID

    Reporting group title
    placebo
    Reporting group description
    		 placebo controlled

    Primary: overall number of exacerbations

    		 Close Top of page
    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
    1
    1
    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
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

    		 Close Top of page
    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
    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
    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
    Vascular disorders
    transient cerebrovascular insufficency
         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
    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
    Stroke in evolution
         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
    Venous thrombosis
         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
    1 / 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
    2 / 228 (0.88%)
    0 / 239 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Arrhythmia
         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
    Surgical and medical procedures
    Aortic bypass
         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
    Nervous system disorders
    Depression
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 239 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         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
    Gastrointestinal disorders
    chest/epigastric pain
         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
    Gallbladder empyema
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COPD exacerbation
         subjects affected / exposed
    16 / 228 (7.02%)
    16 / 239 (6.69%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 228 (1.75%)
    5 / 239 (2.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         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
    Pneumothorax
         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
    Chest pain
         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
    Pulmonary oedema
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         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
    Urinary retention
         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
    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
    Back pain
         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
    Hip fracture
         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
    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%)
    4 / 239 (1.67%)
         occurrences all number
    0
    5
    Insomnia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 239 (0.84%)
         occurrences all number
    0
    2
    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
    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%)
    4 / 239 (1.67%)
         occurrences all number
    5
    6
    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
    1 / 228 (0.44%)
    8 / 239 (3.35%)
         occurrences all number
    1
    9
    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
    Investigations
    Mitral valve replacement
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Chest injury
         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
    1 / 228 (0.44%)
    2 / 239 (0.84%)
         occurrences all number
    1
    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%)
    2 / 239 (0.84%)
         occurrences all number
    9
    2
    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
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 228 (0.00%)
    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
    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
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 228 (0.88%)
    3 / 239 (1.26%)
         occurrences all number
    2
    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
    1 / 228 (0.44%)
    0 / 239 (0.00%)
         occurrences all number
    1
    0
    Acidosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    1
    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
    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
    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
    0 / 228 (0.00%)
    1 / 239 (0.42%)
         occurrences all number
    0
    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
    4 / 228 (1.75%)
    1 / 239 (0.42%)
         occurrences all number
    4
    1
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 239 (0.42%)
         occurrences all number
    2
    1
    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
    2
    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
    1
    1
    Viraemia
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 239 (0.84%)
         occurrences all number
    1
    2
    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

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 05:57:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA