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    Clinical Trial Results:
    A randomised, multi-centre, parallel group, double-blind, placebo-controlled study to assess the efficacy and safety of Oscillococcinum® in the treatment of symptoms of Influenza-like illness (ILI)

    Summary
    EudraCT number
    		 2013-001869-16
    Trial protocol
    		 DE  
    Global end of trial date
    19 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2022
    First version publication date
    08 Jul 2022
    Other versions
    Summary report(s)
    		 Prematurely ended statement

    Trial information

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    Trial identification
    Sponsor protocol code
    BRN-C-2013-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boiron Laboratoires
    Sponsor organisation address
    2 avenue de l'Ouest Lyonnais, Messimy, France, 69510
    Public contact
    Isabelle Chanel - Research and Development Director, Boiron Laboratoires, +33 4 72 16 43 15, isabelle.chanel@boiron.fr
    Scientific contact
    Isabelle Chanel - Research and Development Director, Boiron Laboratoires, +33 4 72 16 43 15, isabelle.chanel@boiron.fr
    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
    10 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of Oscillococcinum® in the treatment of symptoms of Influenza-like illness (ILI).
    Protection of trial subjects
    The Sponsor submitted the study protocol and all information necessary for a detailed review of the clinical study to the competent authority. The study was started after written approval by the competent authority was available. This study was performed in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, in its revision of Somerset West 1996, and in accordance with applicable legal and regulatory requirements, including archiving of essential documents. It was the responsibility of the investigator to obtain signed informed consent from the patient prior to the patient’s inclusion in the study. For patients under 18 years of age, the investigator was obliged to collect signed informed consent not only from the patient, but also from the patient’s parents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2013
    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
    Germany: 362
    Worldwide total number of subjects
    362
    EEA total number of subjects
    362
    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)
    8
    Adults (18-64 years)
    354
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with ILI defined as sudden onset of symptoms and at least 1 of the systemic symptoms and at least 1 of the respiratory symptoms of ≤ 24 hours duration were recruited. Patients were randomized at a rate of 1:1 to receive either Oscillococcinum® or placebo, randomization was stratified in 2 strata depending the symptom scores.

    Pre-assignment
    Screening details
    		 362 patients were enrolled, 351 patients were randomized, 2 patient randomized were not treated. A total of 110 patients (30.4%) was enrolled with baseline total symptom score B 2 - 8 comprising Stratum 1 and 249 patients (68.8%) with baseline total symptom score B ≥ 9 in Stratum 2. Treatment groups were balanced in baseline characteristics.

    Pre-assignment period milestones
    Number of subjects started
    		 362
    Number of subjects completed
    		 349

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 patient non randomized non treated: 8
    Reason: Number of subjects
    		 patient non randomized treated: 3
    Reason: Number of subjects
    		 patients randomized non treated: 2
    Period 1
    Period 1 title
    Randomized phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Study medication was presented as visually indistinguishable doses. Each carton box contained 10 doses which was sufficient medication for 1 patient. Sealed individual random code envelopes were prepared for the purpose of individual unblinding of a patient's treatment allocation. These envelopes were sent to the sites together with the study medication.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oscillococcinum®
    Arm description
    		 Oscillococcinum® was provided as globuli with 1 dose containing 1 g of globuli. Oscillococcinum® contained the extract from Anas barbariae, hepatis and cordis 200K, 0.85 g sucrose, and 0.15 g lactose. Oscillococcinum® were to be taken as 3 oral doses per day over 3 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oscillococcinum®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Oscillococcinum® was to be taken as 3 oral doses per day over 3 days. The entire content of 1 dose was to let melt under the tongue. Patients were to be instructed to take all 9 doses as scheduled even if they were free of symptoms.

    Arm title
    		 Placebo
    Arm description
    		 Placebo were provided as globuli with 1 dose containing 1 g of globuli. Placebo contained 0.85 g sucrose and 0.15 g lactose and it was not possible to differentiate it from Oscillococcinum® by its appearance and taste. Placebo were to be taken as 3 oral doses per day over 3 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo were provided as globuli with 1 dose containing 1 g of globuli. Placebo contained 0.85 g sucrose and 0.15 g lactose and it was not possible to differentiate it from Oscillococcinum® by its appearance and taste.

    Number of subjects in period 1 [1]
    		Oscillococcinum® Placebo
    Started
    175
    174
    Completed
    159
    155
    Not completed
    16
    19
         Consent withdrawn by subject
    -
    5
         Adverse event, non-fatal
    3
    1
         Other
    2
    1
         Lack of compliance
    10
    10
         Lost to follow-up
    1
    2
    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: For the final analysis, 362 patients were enrolled, and 349 patients were included in the efficacy analysis (FAS), representing an overrun of 108 patients compared to the number of patients included in the first interim analysis. A total of 351 patients (97.0 %) was randomised, 175 patients (49.9 %) to Oscillococcinum treatment and 176 patients (50.1 %) to placebo treatment. (see Pre-assignment subject non-completion reasons above)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oscillococcinum®
    Reporting group description
    		 Oscillococcinum® was provided as globuli with 1 dose containing 1 g of globuli. Oscillococcinum® contained the extract from Anas barbariae, hepatis and cordis 200K, 0.85 g sucrose, and 0.15 g lactose. Oscillococcinum® were to be taken as 3 oral doses per day over 3 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo were provided as globuli with 1 dose containing 1 g of globuli. Placebo contained 0.85 g sucrose and 0.15 g lactose and it was not possible to differentiate it from Oscillococcinum® by its appearance and taste. Placebo were to be taken as 3 oral doses per day over 3 days.

    Reporting group values
    		 Oscillococcinum® Placebo Total
    Number of subjects
    		 175 174 349
    Age categorical
    Age of subjects (years)
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 3 5 8
        Adults (18-64 years)
    		 172 169 341
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Mean age of subjects SD (years)
    Units: years
        arithmetic mean (standard deviation)
    		 37.5 ± 12.8 37.6 ± 12.6 -
    Gender categorical
    Units: Subjects
        Female
    		 85 86 171
        Male
    		 90 88 178
    Subject analysis sets

    Subject analysis set title
    Stratum 1 - Oscillococcinum
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B between 2 and 8, inclusively received Oscillococcinum

    Subject analysis set title
    Stratum 1 - Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B between 2 and 8, inclusively received placebo

    Subject analysis set title
    Stratum 2 - Oscillococcinum
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B of 9 or higher receiving Oscillococcinum

    Subject analysis set title
    Stratum 2 - Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B of 9 or higher received placebo

    Subject analysis sets values
    		 Stratum 1 - Oscillococcinum Stratum 1 - Placebo Stratum 2 - Oscillococcinum Stratum 2 - Placebo
    Number of subjects
    52
    55
    123
    119
    Age categorical
    Age of subjects (years)
    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)
    3
    4
    0
    1
        Adults (18-64 years)
    49
    51
    123
    118
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Mean age of subjects SD (years)
    Units: years
        arithmetic mean (standard deviation)
    35.2 ± 12.5
    35.7 ± 13.8
    38.4 ± 12.9
    38.5 ± 12.0
    Gender categorical
    Units: Subjects
        Female
    25
    28
    60
    58
        Male
    27
    27
    63
    61

    End points

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    End points reporting groups
    Reporting group title
    Oscillococcinum®
    Reporting group description
    		 Oscillococcinum® was provided as globuli with 1 dose containing 1 g of globuli. Oscillococcinum® contained the extract from Anas barbariae, hepatis and cordis 200K, 0.85 g sucrose, and 0.15 g lactose. Oscillococcinum® were to be taken as 3 oral doses per day over 3 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo were provided as globuli with 1 dose containing 1 g of globuli. Placebo contained 0.85 g sucrose and 0.15 g lactose and it was not possible to differentiate it from Oscillococcinum® by its appearance and taste. Placebo were to be taken as 3 oral doses per day over 3 days.

    Subject analysis set title
    Stratum 1 - Oscillococcinum
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B between 2 and 8, inclusively received Oscillococcinum

    Subject analysis set title
    Stratum 1 - Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B between 2 and 8, inclusively received placebo

    Subject analysis set title
    Stratum 2 - Oscillococcinum
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B of 9 or higher receiving Oscillococcinum

    Subject analysis set title
    Stratum 2 - Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Randomization to treatment group was stratified according to the total symptom scores at baseline. Patients with a total symptom score version 1 calculated from the baseline symptom score B of 9 or higher received placebo

    Primary: Primary endpoint -Time to absence of systemic flu-like symptoms

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    End point title
    		 Primary endpoint -Time to absence of systemic flu-like symptoms
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Median time will be compared between treatment groups.
    End point type
    Primary
    End point timeframe
    4 days follow up
    End point values
    		 Oscillococcinum® Placebo
    Number of subjects analysed
    175
    174
    Units: hours
        number (not applicable)
    138.3
    148.4
    Statistical analysis title
    		 Primary endpoint FAS
    Statistical analysis description
    Full analysis set
    Comparison groups
    Oscillococcinum® v Placebo
    Number of subjects included in analysis
    349
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4846
    Method
    		 Chi-squared
    Confidence interval

    Primary: Primary endpoint PP Time to absence of systemic flu-like symptoms

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    End point title
    		 Primary endpoint PP Time to absence of systemic flu-like symptoms
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Median time compared for treatment groups
    End point type
    Primary
    End point timeframe
    4 days follow up
    End point values
    		 Oscillococcinum® Placebo
    Number of subjects analysed
    139
    138
    Units: hours
        number (not applicable)
    121.8
    134.4
    Statistical analysis title
    		 Primary endpoint PP
    Statistical analysis description
    Per protocol population
    Comparison groups
    Oscillococcinum® v Placebo
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4799
    Method
    		 Chi-squared
    Confidence interval

    Primary: Primary endpoint Stratum 1

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    End point title
    		 Primary endpoint Stratum 1
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Comparison of median time between patients data of stratum 1 randomized to Oscillococcinum or Placebo group.
    End point type
    Primary
    End point timeframe
    4 day follow up
    End point values
    		 Stratum 1 - Oscillococcinum Stratum 1 - Placebo
    Number of subjects analysed
    52
    55
    Units: hours
        number (not applicable)
    90.3
    117.5
    Statistical analysis title
    		 Primary endpoint Stratum 1
    Statistical analysis description
    Full analysis set for patients in Stratum 1
    Comparison groups
    Stratum 1 - Oscillococcinum v Stratum 1 - Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0567
    Method
    		 Chi-squared
    Confidence interval

    Primary: Primary endpoint Stratum 2

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    End point title
    		 Primary endpoint Stratum 2
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Comparison of median time between patients data of stratum 2 randomized to Oscillococcinum or Placebo group.
    End point type
    Primary
    End point timeframe
    4 days follow up
    End point values
    		 Stratum 2 - Oscillococcinum Stratum 2 - Placebo
    Number of subjects analysed
    123
    119
    Units: hours
        number (not applicable)
    0
    175
    Statistical analysis title
    		 Primary endpoint Stratum 2
    Statistical analysis description
    Full analysis set
    Comparison groups
    Stratum 2 - Oscillococcinum v Stratum 2 - Placebo
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.506 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - Median time to absence of systemic flu-like symptoms (h) value for Stratum 2 Oscillococcinum group is reported as “0” in the above tabulated results, since it could not been determined in the follow up time.

    Primary: Primary endpoint Stratum 1 - PP

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    End point title
    		 Primary endpoint Stratum 1 - PP
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Comparison of median time between patients data of stratum 1 randomized to Oscillococcinum or Placebo group.
    End point type
    Primary
    End point timeframe
    4 day follow up
    End point values
    		 Stratum 1 - Oscillococcinum Stratum 1 - Placebo
    Number of subjects analysed
    44
    45
    Units: hours
        number (not applicable)
    89.2
    113.5
    Statistical analysis title
    		 Primary endpoint Stratum 1 PP
    Comparison groups
    Stratum 1 - Oscillococcinum v Stratum 1 - Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0359
    Method
    		 Chi-squared
    Confidence interval

    Primary: Primary endpoint Stratum 2 - PP

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    End point title
    		 Primary endpoint Stratum 2 - PP
    End point description
    Time from first intake of study medication to the first occurrence of no fever (body temperature < 37.8°C) AND chills, headache, myalgia, and malaise recorded as 'none'. Scores of 'none' for fever, chills, headache, myalgia, and malaise had to be maintained over 24 hours. Comparison of median time between patients data of stratum 2 randomized to Oscillococcinum or Placebo group.
    End point type
    Primary
    End point timeframe
    4 days follow up
    End point values
    		 Stratum 2 - Oscillococcinum Stratum 2 - Placebo
    Number of subjects analysed
    95
    93
    Units: hours
        number (not applicable)
    190.5
    148.4
    Statistical analysis title
    		 Primary endpoint Stratum 2 PP
    Comparison groups
    Stratum 2 - Oscillococcinum v Stratum 2 - Placebo
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4007
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 days follow up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Oscillococcinum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Oscillococcinum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Bronchitis
    Additional description: Patient with bronchitis and sinusitis
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Oscillococcinum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 176 (11.36%)
    19 / 176 (10.80%)
    Investigations
    Legionella test positive
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    Body temperature decreased
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    Sensation of foreign body
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Tinnitus
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    Flatulence
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Toothache
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Gastrointestinal hypomotility
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Mucous stools
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    Back pain
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 176 (1.14%)
    3 / 176 (1.70%)
         occurrences all number
    2
    3
    Sinusitis
         subjects affected / exposed
    3 / 176 (1.70%)
    1 / 176 (0.57%)
         occurrences all number
    3
    1
    Otitis media
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Pertussis
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Sinobronchitis
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Sinusitis bacterial
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2013
    Amendment 2; included minor formal corrections, changes and clarifications regarding study variables, addition of two new variables, a modification of the statistical analysis of the primary efficacy endpoint, a detailed definition of the process of obtaining informed consent for children.

    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.
    The trial was prematurely terminated following the first previewed interim analysis for futility.
    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.

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