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    Clinical Trial Results:
    Bilastine and Montelukast in patients with Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study

    Summary
    EudraCT number
    		 2015-004806-40
    Trial protocol
    		 SK   CZ   PL   LV   HR   IT  
    Global end of trial date
    23 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2018
    First version publication date
    07 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEIN/15/Bil-ARC/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini International Operations Luxembourg S.A
    Sponsor organisation address
    1, Avenue de la Gare, Luxembourg, Luxembourg, L-1611
    Public contact
    Paolo Fabrizzi, Menarini International Operations Luxembourg S.A., +39 055 5680459, pfabrizzi@menarini.it
    Scientific contact
    Paolo Fabrizzi, Menarini International Operations Luxembourg S.A., +39 055 5680459, pfabrizzi@menarini.it
    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
    14 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that concomitant administration of montelukast and bilastine is superior to bilastine monotherapy in SARC symptoms, as assessed by Total Symptoms Scores (TSS) after 4 weeks of treatment
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2016
    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
    Poland: 295
    Country: Number of subjects enrolled
    Slovakia: 21
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Czech Republic: 72
    Country: Number of subjects enrolled
    Latvia: 23
    Country: Number of subjects enrolled
    Italy: 4
    Worldwide total number of subjects
    420
    EEA total number of subjects
    420
    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)
    420
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment started on 13 April 2016 and termineted on 23 November 2016. 454 patients with SARC and mild to moderate asthma as comorbidity were screened. 420 patients were randomised of which 388 patients completed the study.

    Pre-assignment
    Screening details
    		 454 patients with SARC and mild to moderate asthma as comorbidity were screened.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bilastine Monotherapy
    Arm description
    		 Bilastine 20 mg tablets + placebo tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg/die

    Arm title
    		 Montelukast Monotherapy
    Arm description
    		 Montelukast 10 mg tablets + placebo tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/die

    Arm title
    		 Bilastine + Montelukast
    Arm description
    		 bilastine 20 mg tablets + montelukast 10 mg tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day

    Investigational medicinal product name
    bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg/die

    Number of subjects in period 1
    		Bilastine Monotherapy Montelukast Monotherapy Bilastine + Montelukast
    Started
    140
    137
    143
    Completed
    132
    123
    133
    Not completed
    8
    14
    10
         Physician decision
    1
    1
    -
         Consent withdrawn by subject
    3
    4
    4
         Pregnancy
    -
    -
    1
         Drug intollerance
    -
    1
    -
         Lost to follow-up
    -
    -
    1
         Protocol deviation
    4
    8
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bilastine Monotherapy
    Reporting group description
    		 Bilastine 20 mg tablets + placebo tablets

    Reporting group title
    Montelukast Monotherapy
    Reporting group description
    		 Montelukast 10 mg tablets + placebo tablets

    Reporting group title
    Bilastine + Montelukast
    Reporting group description
    		 bilastine 20 mg tablets + montelukast 10 mg tablets

    Reporting group values
    		 Bilastine Monotherapy Montelukast Monotherapy Bilastine + Montelukast Total
    Number of subjects
    		 140 137 143 420
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 140 137 143 420
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.5 ± 11.0 35.4 ± 10.7 34.9 ± 11.1 -
    Gender categorical
    Units: Subjects
        Female
    		 83 73 69 225
        Male
    		 57 64 74 195

    End points

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    End points reporting groups
    Reporting group title
    Bilastine Monotherapy
    Reporting group description
    		 Bilastine 20 mg tablets + placebo tablets

    Reporting group title
    Montelukast Monotherapy
    Reporting group description
    		 Montelukast 10 mg tablets + placebo tablets

    Reporting group title
    Bilastine + Montelukast
    Reporting group description
    		 bilastine 20 mg tablets + montelukast 10 mg tablets

    Subject analysis set title
    Montelukast Monotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    IIT population who have taken Montelukast

    Subject analysis set title
    Bilastine Monotherapy
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    IIT population for Bilastine Monotherapy

    Subject analysis set title
    Bilastine + Montelukast
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    IIT population for Bilastine + Montelukast therapy

    Primary: Montelukast+Bilastine is superior to Bilastine Monotherapy in SARC symptoms

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    End point title
    		 Montelukast+Bilastine is superior to Bilastine Monotherapy in SARC symptoms
    End point description
    The primary objective of the study was to demonstrate that concomitant administration of Montelukast and Bilastine is superior to Bilastine monotherapy in SARC symptoms, assessed by total Symptoms Scores after 4 weeks of treatment.
    End point type
    Primary
    End point timeframe
    4 weeks of treatment (from baseline to 4 weeks of treatment)
    End point values
    		 Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    140
    143
    Units: TSS score
        number (confidence interval 95%)
    -3.4462 (-4.0708 to -2.8217)
    -3.2522 (-3.8718 to -2.6327)
    Statistical analysis title
    		 Montelukast+Bilastine vs Bilastine in TSS -4 weeks
    Statistical analysis description
    Considering the ITT patients, the primary efficacy endpoint (i.e. the TSS) was assessed by analysis of covariance (ANCOVA) with the TSS change from baseline to after 4 weeks of treatment (calculated as difference in average post-baseline TSS to baseline TSS) as the dependent variable, treatment as fixed effect, centre as random effect, and baseline TSS as covariate.
    Comparison groups
    Bilastine Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5721
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.194
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8693
         upper limit
    		 0.4813
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3429

    Secondary: Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in asthma control

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    End point title
    		 Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in asthma control
    End point description
    To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in asthma control, as assessed by Asthma Quality of Life Questionnaire (AQLQ) after 4 weeks and at the end of treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatments and in the end of study (from baseline)
    End point values
    		 Montelukast Monotherapy Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    136
    140
    143
    Units: AQLQ SCORE
        number (confidence interval 95%)
    0.5849 (0.4344 to 0.7353)
    0.6399 (0.4929 to 0.7870)
    0.6250 (0.4788 to 0.7712)
    Statistical analysis title
    		 Bila vs Bila+Monte in asthma with AQLQ at 4 week
    Comparison groups
    Montelukast Monotherapy v Bilastine Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0105 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1552
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.0379
         upper limit
    		 -0.2725
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4489
    Notes
    [1] - The P-value reported above refers to Bil vs Bil+Monte. P-Value=0.5443 for Monte vs Bil+Monte. P-Value=0.0645 for Bil vs Monte

    Secondary: Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in SARC symptoms (DNSS)

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    End point title
    		 Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in SARC symptoms (DNSS)
    End point description
    To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Nasal Symptom Score (DNSS) after 4 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment (from baseline).
    End point values
    		 Montelukast Monotherapy Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    136
    140
    143
    Units: DNSS score
        number (confidence interval 95%)
    -1.8678 (-2.2468 to -1.4888)
    -2.1106 (-2.4863 to -1.7349)
    -1.9713 (-2.3442 to -1.5984)
    Statistical analysis title
    		 Bila vs Bila+Monte in SARC with DNSS at 4 weeks
    Comparison groups
    Montelukast Monotherapy v Bilastine Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4885 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1393
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5342
         upper limit
    		 0.2557
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2009
    Notes
    [2] - The P-Value above refers to Bil vs Bil+Monte. P-Value= 0.6092 for Monte vs Bil+Monte P-Value=0.2332 for Bil vs Monte

    Secondary: Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in SARC symptoms (DNNSS)

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    End point title
    		 Montelukast+Bilastine compared with Montelukast and Bilastine monotherapies in SARC symptoms (DNNSS)
    End point description
    To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Non Nasal Symptom Score (DNNSS) after 4 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    After 4 weeks of treatment (from baseline).
    End point values
    		 Montelukast Monotherapy Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    136
    140
    143
    Units: DNNSS score
        number (confidence interval 95%)
    -1.1574 (-1.4462 to -0.8687)
    -1.3185 (-1.6051 to -1.0320)
    -1.2824 (-1.5667 to -0.9980)
    Statistical analysis title
    		 Bila vs Bila+Monte in SARC with DNNSS at 4 weeks
    Comparison groups
    Bilastine Monotherapy v Montelukast Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81032 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03615
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3319
         upper limit
    		 0.2596
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1504
    Notes
    [3] - The P-Value above refers to Bil vs Bil+Monte. P-Value= 0.5443 for Monte vs Bil+Monte P-Value=0.0645 for Bil vs Monte

    Secondary: Usage of relief medication for SARC

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    End point title
    		 Usage of relief medication for SARC
    End point description
    Number of days without any relief medication for SARC.
    End point type
    Secondary
    End point timeframe
    From baseline to 4 weeks of treatment.
    End point values
    		 Montelukast Monotherapy Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    136
    140
    143
    Units: Days
        number (confidence interval 95%)
    15.4179 (13.7642 to 17.0715)
    15.8416 (14.2047 to 17.4785)
    15.0057 (13.3817 to 16.6296)
    Statistical analysis title
    		 Relief medication for SARC
    Comparison groups
    Montelukast Monotherapy v Bilastine Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3704 [4]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8359
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9969
         upper limit
    		 2.6688
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9322
    Notes
    [4] - The P-Value above refers to Bil vs Bil+Monte. P-Value= 0.6610 for Monte vs Bil+Monte P-Value=0.6538 for Bil vs Monte

    Secondary: Use of relief mediction for Asthma

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    End point title
    		 Use of relief mediction for Asthma
    End point description
    Number of days without any relief medication for Asthma.
    End point type
    Secondary
    End point timeframe
    From baseline to 4 weeks of treatment.
    End point values
    		 Montelukast Monotherapy Bilastine Monotherapy Bilastine + Montelukast
    Number of subjects analysed
    136
    140
    143
    Units: Days
        number (confidence interval 95%)
    50.7146 (46.3271 to 55.1021)
    52.4177 (48.0780 to 56.7574)
    53.2548 (48.9515 to 57.5580)
    Statistical analysis title
    		 Relierf medication for Asthma
    Comparison groups
    Montelukast Monotherapy v Bilastine Monotherapy v Bilastine + Montelukast
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7452 [5]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.837
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8968
         upper limit
    		 4.2228
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.5735
    Notes
    [5] - The P-Value above refers to Bil vs Bil+Monte. P-Value= 0.3278 for Monte vs Bil+Monte P-Value= 0.5138 for Bil vs Monte

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entiere treatment period (85 days, 12 weeks).
    Adverse event reporting additional description
    The tolerability was excellent with overall low rates of TEAEs, patient reporting TEAEs and TEAEs recorded as related to study medication during an entire treatment period of 85 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Bilastine
    Reporting group description
    		 -

    Reporting group title
    Montelukast
    Reporting group description
    		 -

    Reporting group title
    Bilastine + Montelukast
    Reporting group description
    		 -

    Serious adverse events
    		 Bilastine Montelukast Bilastine + Montelukast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Bilastine Montelukast Bilastine + Montelukast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 140 (2.86%)
    14 / 137 (10.22%)
    8 / 143 (5.59%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 140 (0.00%)
    0 / 137 (0.00%)
    2 / 143 (1.40%)
         occurrences all number
    5
    14
    14
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 140 (0.00%)
    0 / 137 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 140 (0.00%)
    2 / 137 (1.46%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Headache
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14
    Hypoaesthesia
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Sedation
         subjects affected / exposed
    0 / 140 (0.00%)
    0 / 137 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14
    Somnolence
         subjects affected / exposed
    2 / 140 (1.43%)
    2 / 137 (1.46%)
    2 / 143 (1.40%)
         occurrences all number
    5
    14
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 140 (0.71%)
    0 / 137 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Oedema peripheral
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 140 (0.71%)
    0 / 137 (0.00%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Gingival bleeding
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Insomnia
         subjects affected / exposed
    0 / 140 (0.00%)
    0 / 137 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14
    Irritability
         subjects affected / exposed
    0 / 140 (0.00%)
    1 / 137 (0.73%)
    0 / 143 (0.00%)
         occurrences all number
    5
    14
    14
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 140 (0.71%)
    0 / 137 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    5
    14
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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