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    Clinical Trial Results:
    Safety and efficacy of eslicarbazepine acetate (ESL) as adjunctive therapy for partial seizures in elderly patients

    Summary
    EudraCT number
    2009-012587-14
    Trial protocol
    ES   CZ   AT   PT   DE   BG  
    Global end of trial date
    08 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Apr 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIA-2093-401
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01422720
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    BIAL - Portela & CA, S.A.
    Sponsor organisation address
    À Av. Siderurgia Nacional, Coronado, Portugal, 4745-457
    Public contact
    André Garrido, BIAL - Portela & Cª, S.A., 00351 229866100, andre.garrido@bial.com
    Scientific contact
    José Francisco Rocha, BIAL - Portela & Cª, S.A., 00351 229866100, jose.rocha@bial.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
    24 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To evaluate the safety and tolerability of ESL as adjunctive therapy in patients aged ≥65 years with partial epilepsy, over a 26-week Treatment Period. Secondary: To explore the efficacy of ESL as adjunctive therapy in patients aged ≥65 years with partial epilepsy, over a 26-week Treatment Period.
    Protection of trial subjects
    The trial was conducted in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP), Good Manufacturing Practice (GMP), the ethical principles of the Declaration of Helsinki and with applicable local regulations. This trial was conducted by qualified persons who respected the rights and welfare of the subjects and after the review and approval of the protocol by an EC. Adverse events were collected during the trial and subject was followed by 4 weeks after last treatment visit.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Apr 2010
    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
    Spain: 10
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Bulgaria: 10
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    Czech Republic: 17
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Romania: 8
    Worldwide total number of subjects
    72
    EEA total number of subjects
    60
    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)
    0
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The recruitment period duration is expected to be approximately 9 months. Planned Number of Study Centres: 40 study centres in Austria, Croatia, Czech Republic, France, Germany, Poland, Portugal, Romania and Spain. Other countries may be added.

    Pre-assignment
    Screening details
    Subjects who met all the inclusion criteria and none of the exclusion criteria. 99 subjects were enrolled to the trial and 27 subjects were screening failures.

    Pre-assignment period milestones
    Number of subjects started
    99 [1]
    Number of subjects completed
    72

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Adverse event, serious non-fatal: 1
    Reason: Number of subjects
    Consent withdrawn by subject: 8
    Reason: Number of subjects
    Ineligibility: 16
    Reason: Number of subjects
    Patient's non-compliance: 1
    Reason: Number of subjects
    Due the anual hospitalization: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period is the number of enrolled subjects; The worldwide number is number of treated subjects.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Eslicarbazepine acetate
    Arm description
    Eslicarbazepine acetate (ESL); ESL tablets (800 mg) QD; Other Name: Zebinix
    Arm type
    Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For patients with CLCR above 60 mL/min the recommended starting dose is 400 mg once daily for two weeks. Thereafter, investigators are free to uptitrate the drug in 400 mg steps until a maximum of 1200 mg once daily. Titration can be upwards or downwards based on individual response. In this study the maximum daily dose allowed will be 1200 mg and the minimum dose will be 400 mg. At the end of the treatment period the dose of ESL will be tapered off at 400 mg steps each week and standard anti-epileptic treatment will be introduced.

    Number of subjects in period 1
    Eslicarbazepine acetate
    Started
    72
    Completed
    50
    Not completed
    22
         Ineligibility
    1
         Lack of efficacy
    1
         Adverse event, serious fatal
    3
         Adverse event, non-fatal
    10
         Consent withdrawn by subject
    4
         Adverse event, serious non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eslicarbazepine acetate
    Reporting group description
    Eslicarbazepine acetate (ESL); ESL tablets (800 mg) QD; Other Name: Zebinix

    Reporting group values
    Eslicarbazepine acetate Total
    Number of subjects
    72 72
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    0 0
        Preterm newborn- gestational age < 37 wk
    0 0
        Newborns (0-27days)
    0 0
        Infants and toddlers (28days – 23months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 year)
    0 0
        From 18 - 64 years
    0 0
        From 65 – 84 years
    72 72
        Over 85 years
    0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    71.6 ± 5.4 -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    34 34
        Male
    38 38

    End points

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    End points reporting groups
    Reporting group title
    Eslicarbazepine acetate
    Reporting group description
    Eslicarbazepine acetate (ESL); ESL tablets (800 mg) QD; Other Name: Zebinix

    Subject analysis set title
    ESL x Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety set will consist of all patients who received at least 1 dose of study medication.

    Subject analysis set title
    ESL x Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS will consist of all patients who received at least 1 dose of study medication and had at least 1 day of seizure evaluation reported in the patient diary after Visit 2.

    Subject analysis set title
    ESL x Per protocol population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The PP set will consist of all patients in the FAS who have completed the Treatment Period and do not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not patient) exclusion.

    Primary: Number of Subjects With Reported Adverse Events (AE)

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    End point title
    Number of Subjects With Reported Adverse Events (AE) [1]
    End point description
    Number of Subjects With Reported Adverse Events (AE)
    End point type
    Primary
    End point timeframe
    Throughout the study
    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: No statistical analyses were foreseen.
    End point values
    ESL x Safety population
    Number of subjects analysed
    72
    Units: Number of Subjects
    number (not applicable)
        who died
    3
        who died due to TEAE
    3
        with at least one SAE
    11
        with at least one TESAE
    10
        who prematurely terminated the study due to TEAE
    16
        with at least one TEAE
    47
        with at least one related TEAE
    31
        with at least one severe TEAE
    12
    No statistical analyses for this end point

    Secondary: Absolute change from baseline of seizure frequency standardised to a frequency per 4 weeks

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    End point title
    Absolute change from baseline of seizure frequency standardised to a frequency per 4 weeks
    End point description
    Absolute change from baseline of seizure frequency standardised to a frequency per 4 weeks
    End point type
    Secondary
    End point timeframe
    8-week Baseline Period and 26-week Treatment Period
    End point values
    ESL x Full analysis set ESL x Per protocol population
    Number of subjects analysed
    71
    55
    Units: Number of seizures
    arithmetic mean (standard deviation)
        Number of seizures
    -1.3 ± 4.17
    -0.9 ± 3.41
    No statistical analyses for this end point

    Secondary: Relative change from baseline of seizure frequency standardised to a frequency per 4 weeks

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    End point title
    Relative change from baseline of seizure frequency standardised to a frequency per 4 weeks
    End point description
    Relative change from baseline of seizure frequency standardised to a frequency per 4 weeks
    End point type
    Secondary
    End point timeframe
    8-week Baseline Period and 26-week Treatment Period
    End point values
    ESL x Full analysis set ESL x Per protocol population
    Number of subjects analysed
    71
    55
    Units: Number of seizures
    arithmetic mean (standard deviation)
        Number of seizures
    -35 ± 65.31
    -37.5 ± 61.26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    ESL x Safety population
    Reporting group description
    Subjects in Safety population

    Serious adverse events
    ESL x Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 72 (15.28%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Prostate cancer
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Upper airway obstruction
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lacunar infarction
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Postictal psychosis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    ESL x Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 72 (65.28%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    Orthostatic hypotension
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences all number
    8
    Gait disturbance
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Puncture site reaction
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Localised oedema
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Spinal pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Confusional state
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Depressed mood
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Injury corneal
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Investigations
    Blood potassium decreased
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    White blood cell count decreased
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Blood urea increased
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hypertensive heart disease
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Sneezing
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    10 / 72 (13.89%)
         occurrences all number
    13
    Dysgeusia
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Convulsion
         subjects affected / exposed
    6 / 72 (8.33%)
         occurrences all number
    6
    Hypersomnia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    7
    Lethargy
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences all number
    7
    Paraesthesia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Dental caries
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    4
    Dysphagia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin burning sensation
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Purpura
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Joint stiffness
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gout
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences all number
    7
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    6 / 72 (8.33%)
         occurrences all number
    7
    Influenza
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    5
    Urosepsis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Nov 2009
    Clinical Trial Protocol Amendment # 1 – Spain; Synopsis (Subsection Study Design), Section 8.7 and Section 18.7.2 were updated
    07 Jan 2010
    Global Protocol Amendment # 1; Synopsis (Sub-Section Criteria for Evaluation: Safety), Section 9.2, Section 9.2.3.5, Section 9.6.2, Section 9.6.2, Section 9.6.3, Section 9.6.5, Section 9.6.6, Section 9.6.7, Section 11.1.1 and Section 18.7.1 were updated
    27 Jan 2010
    Clinical Trial Protocol Amendment # 1 – Germany; Synopsis (Sub-Section Exclusion Criteria), Section 7.2.2, Section 7.2.3, Section 7.5.2 and Section 15.6 were updated
    21 Jun 2011
    Global Protocol Amendment # 2; Synopsis Section Inclusion Criteria, and Section 7.2.1 Inclusion Criteria and Section 7.3.1 Screening Failures were updated
    17 Nov 2011
    Protocol Changes for (Asia) Amendment No. 1; Section 9.3.1, Section 9.4.2, Section 14.2 and Section 7.6 were updated
    21 Nov 2011
    Protocol Changes for South Korea Amendment No. 1; Section 7.6, Section 8.1, Section 9.3.1, Section 9.4.2, Section 14.2 were updated, Administrative revisions were done as well

    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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