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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age

    Summary
    EudraCT number
    		 2009-014811-11
    Trial protocol
    		 ES   CZ   SK   Outside EU/EEA  
    Global end of trial date
    11 Jun 2012

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jul 2016
    First version publication date
    05 Feb 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R076477PSZ3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01009047
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Antwerpseweg 15-17, B-2340 Beerse , Belgium,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, +1 609-730-2436, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, +1 609-730-2436, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000014-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jun 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jun 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of paliperidone PR relative to aripiprazole in the treatment of symptoms of schizophrenia in adolescent subjects (aged 12 to 17 years of age, inclusive) at the Week 8 endpoint as measured by the change from baseline in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) total score.
    Protection of trial subjects
    The safety assessments included laboratory measurements (for example, chemistry, hematology, urinalysis, lipid panel, and insulin related tests), body weight, waist circumference, electrocardiograms (ECGs), and physical examination. The Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Rating Scale (SARS) were used to assess extrapyramidal symptoms (EPS) and dyskinesia. The Columbia Suicide Severity Rating Scale (C-SSRS) was administered to assess suicidality. Adverse events and vital signs were monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2009
    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
    India: 39
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Russian Federation: 114
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Ukraine: 37
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    Spain: 5
    Worldwide total number of subjects
    227
    EEA total number of subjects
    15
    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)
    227
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 228 subjects were included in the all randomized analysis set, 227 included in the safety analysis set and 226 in the intent-to-treat analysis set.

    Pre-assignment
    Screening details
    		 A total of 41 sites in 7 countries participated in this study including 6 sites in India, 1 site in Romania, 16 sites in Russian Federation, 1 site in Slovakia, 3 sites in Spain, 8 sites in Ukraine, and 6 sites in the United States.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    To maintain the blind, study drug was packaged in blister cards which contained over encapsulated tablets.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paliperidone ER
    Arm description
    		 Paliperidone extended release (ER) was administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then was administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone ER
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Paliperidone ER was administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then was be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

    Arm title
    		 Aripiprazole
    Arm description
    		 Aripiprazole was administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 on mg Days 5, 6 and 7; and then was administered at a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Aripiprazole was administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg on Days 5, 6 and 7; and then was administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

    Number of subjects in period 1
    		Paliperidone ER Aripiprazole
    Started
    113
    114
    Completed
    85
    89
    Not completed
    28
    25
         Lost To Follow-Up
    -
    2
         Adverse Event
    5
    -
         Other
    3
    1
         Lack Of Efficacy
    4
    11
         Withdrawal Of Consent
    16
    11

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Paliperidone ER
    Reporting group description
    		 Paliperidone extended release (ER) was administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then was administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole was administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 on mg Days 5, 6 and 7; and then was administered at a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

    Reporting group values
    		 Paliperidone ER Aripiprazole Total
    Number of subjects
    		 113 114 227
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 113 114 227
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.3 ± 1.47 15.4 ± 1.45 -
    Title for Gender
    Units: subjects
        Female
    		 39 38 77
        Male
    		 74 76 150

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Paliperidone ER
    Reporting group description
    		 Paliperidone extended release (ER) was administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then was administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole was administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 on mg Days 5, 6 and 7; and then was administered at a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

    Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

    		 Close Top of page
    End point title
    		 Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
    End point description
    The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. The intent-to-treat (ITT) population was used as analysis set which included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
    End point type
    Primary
    End point timeframe
    Baseline and Day 56
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    89.6 ± 12.22
    92 ± 12.09
        Day 56
    -19.3 ± 13.8
    -19.8 ± 14.56
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.935
    Method
    		 ANCOVA
    Parameter type
    		 L S mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.46
         upper limit
    		 3.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.83

    Secondary: Change From Baseline in PANSS Total Score at Day 182

    		 Close Top of page
    End point title
    		 Change From Baseline in PANSS Total Score at Day 182
    End point description
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    89.6 ± 12.22
    92 ± 12.09
        Change at Day 182
    -25.6 ± 16.88
    -26.8 ± 18.82
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.877
    Method
    		 ANCOVA
    Parameter type
    		 L S mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.68
         upper limit
    		 4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.2

    Secondary: Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182

    		 Close Top of page
    End point title
    		 Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
    End point description
    The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56 and Day 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    23.2 ± 4.92
    23.3 ± 4.54
        Change at Day 56
    -4.3 ± 4.56
    -4.7 ± 4.61
        Change at Day 182
    -6 ± 5.51
    -6.2 ± 5.84
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.341
    Method
    		 ANCOVA
    Parameter type
    		 L S mean difference
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 1.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.723
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 1.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66

    Secondary: Change From Baseline in Other Marder Factors Scores at Day 56 and 182

    		 Close Top of page
    End point title
    		 Change From Baseline in Other Marder Factors Scores at Day 56 and 182
    End point description
    The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56 and 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Positive symptoms
    24.6 ± 4.08
    24.9 ± 4.32
        Change at Day 56: Positive symptoms
    -6.1 ± 4.96
    -5.6 ± 4.83
        Change at Day 182: Positive symptoms
    -7.8 ± 5.82
    -7.8 ± 6.03
        Baseline: Negative symptoms
    23.2 ± 4.92
    23.3 ± 4.54
        Change at Day 56: Negative symptoms
    -4.3 ± 4.56
    -4.7 ± 4.61
        Change at Day 182: Negative symptoms
    -6 ± 5.51
    -6.2 ± 5.84
        Baseline: Disorganized thoughts
    21.4 ± 4.4
    22.1 ± 3.86
        Change at Day 56: Disorganized thoughts
    -4 ± 3.34
    -4.1 ± 3.4
        Change at Day 182: Disorganized thoughts
    -5.5 ± 4.18
    -5.7 ± 4.46
        Baseline: Uncontrolled hostility
    10.7 ± 3.19
    11.7 ± 3.48
        Change at Day 56: Uncontrolled hostility
    -2.5 ± 2.67
    -2.9 ± 3.05
        Change at Day 182: Uncontrolled hostility
    -3.2 ± 3.11
    -3.8 ± 3.97
        Baseline: Anxiety/depression
    9.7 ± 3.17
    10 ± 3.26
        Change at Day 56: Anxiety/depression
    -2.4 ± 3.08
    -2.6 ± 2.81
        Change at Day 182: Anxiety/depression
    -3 ± 3.29
    -3.2 ± 3.17
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.351
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.691
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.965
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.766
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.984
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.985
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.803
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.745
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182

    		 Close Top of page
    End point title
    		 Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
    End point description
    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56 and 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Positive Subscale
    21.5 ± 4.14
    22.5 ± 4.26
        Change at Day 56: Positive Subscale
    -6.4 ± 4.54
    -6.2 ± 4.91
        Change at Day 182: Positive Subscale
    -8 ± 5.16
    -8.3 ± 6.09
        Baseline: Negative Subscale
    23.8 ± 4.55
    24.2 ± 4.32
        Change at Day 56: Negative Subscale
    -4.2 ± 4.25
    4.5 ± 4.25
        Change at Day 182: Negative Subscale
    -5.7 ± 5.15
    -6.1 ± 5.47
        Baseline: General Psychopathology
    44.3 ± 7.47
    45.3 ± 7.01
        Change at Day 56: General Psychopathology
    -8.7 ± 7.35
    -9.1 ± 7.25
        Change at Day 182: General Psychopathology
    -11.9 ± 9.02
    -12.4 ± 9.41
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Stability

    		 Close Top of page
    End point title
    		 Number of Participants With Clinical Stability
    End point description
    Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.
    End point type
    Secondary
    End point timeframe
    Day 56 and 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: participants
    58
    68
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.296
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182

    		 Close Top of page
    End point title
    		 Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
    End point description
    The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56 and 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    median (full range (min-max))
        Baseline
    4 (3 to 6)
    4 (3 to 6)
        Change at Day 56
    -1 (-4 to 0)
    -1 (-3 to 1)
        Change at Day 182
    -1 (-4 to 1)
    -1 (-4 to 1)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.
    Comparison groups
    Aripiprazole v Paliperidone ER
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.843
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.914
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182

    		 Close Top of page
    End point title
    		 Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
    End point description
    The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 56 and Day 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    49.8 ± 10.32
    49.2 ± 10.21
        Change at Day 56
    12.2 ± 11.72
    12.2 ± 10.17
        Change at Day 182
    17.1 ± 14.46
    17.1 ± 14.03
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.895
    Method
    		 ANCOVA
    Parameter type
    		 L S mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 2.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.27
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.705
    Method
    		 ANCOVA
    Parameter type
    		 L S mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.64
         upper limit
    		 3.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.66

    Secondary: Number of Participants With PANSS Response

    		 Close Top of page
    End point title
    		 Number of Participants With PANSS Response
    End point description
    The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.
    End point type
    Secondary
    End point timeframe
    Day 56 and 182
    End point values
    		 Paliperidone ER Aripiprazole
    Number of subjects analysed
    112
    114
    Units: participants
        Day 56
    76
    87
        Day 182
    86
    93
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.119
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.
    Comparison groups
    Paliperidone ER v Aripiprazole
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.444
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 26
    Adverse event reporting additional description
    The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

    Reporting group title
    Paliperidone ER
    Reporting group description
    		 Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

    Serious adverse events
    		 Aripiprazole Paliperidone ER
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 114 (6.14%)
    7 / 113 (6.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    4 / 114 (3.51%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia, paranoid type
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (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
    		 Aripiprazole Paliperidone ER
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 114 (65.79%)
    87 / 113 (76.99%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 114 (0.88%)
    6 / 113 (5.31%)
         occurrences all number
    1
    7
    Fatigue
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 113 (0.88%)
         occurrences all number
    2
    2
    Feeling jittery
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Irritability
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 113 (1.77%)
         occurrences all number
    1
    2
    Thirst
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Social circumstances
    Sexual activity increased
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Epididymitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Galactorrhoea
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 113 (1.77%)
         occurrences all number
    1
    3
    Gynaecomastia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Menstruation irregular
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Abnormal dreams
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Agitation
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 113 (0.88%)
         occurrences all number
    2
    1
    Anxiety
         subjects affected / exposed
    3 / 114 (2.63%)
    5 / 113 (4.42%)
         occurrences all number
    3
    6
    Depression
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 113 (2.65%)
         occurrences all number
    2
    4
    Dyssomnia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    3
    Hostility
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Libido decreased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    9 / 114 (7.89%)
    6 / 113 (5.31%)
         occurrences all number
    12
    9
    Mood swings
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Psychogenic pain disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Psychotic disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Schizophrenia
         subjects affected / exposed
    10 / 114 (8.77%)
    3 / 113 (2.65%)
         occurrences all number
    12
    5
    Sleep disorder
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Social avoidant behaviour
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Suicidal ideation
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Suicide attempt
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Blood glucose
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Gastric pH decreased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 113 (0.00%)
         occurrences all number
    4
    0
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    7 / 114 (6.14%)
    12 / 113 (10.62%)
         occurrences all number
    7
    14
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 113 (2.65%)
         occurrences all number
    3
    4
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    9 / 114 (7.89%)
    13 / 113 (11.50%)
         occurrences all number
    10
    13
    Disturbance in attention
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Dysarthria
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Drooling
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Dyskinesia
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Dystonia
         subjects affected / exposed
    3 / 114 (2.63%)
    1 / 113 (0.88%)
         occurrences all number
    3
    1
    Extrapyramidal disorder
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 113 (2.65%)
         occurrences all number
    2
    3
    Grimacing
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    5 / 114 (4.39%)
    12 / 113 (10.62%)
         occurrences all number
    6
    18
    Hypersomnia
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Lethargy
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    2
    Hypokinesia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Parkinsonism
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 113 (1.77%)
         occurrences all number
    4
    2
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Sedation
         subjects affected / exposed
    3 / 114 (2.63%)
    6 / 113 (5.31%)
         occurrences all number
    4
    6
    Tremor
         subjects affected / exposed
    11 / 114 (9.65%)
    12 / 113 (10.62%)
         occurrences all number
    12
    13
    Somnolence
         subjects affected / exposed
    12 / 114 (10.53%)
    12 / 113 (10.62%)
         occurrences all number
    13
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Eosinophilia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Monocytopenia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 114 (0.88%)
    5 / 113 (4.42%)
         occurrences all number
    2
    7
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Blepharospasm
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Oculogyric crisis
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 113 (2.65%)
         occurrences all number
    0
    4
    Photophobia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 113 (2.65%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    3
    Diarrhoea
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 113 (0.88%)
         occurrences all number
    2
    1
    Dyspepsia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Eructation
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    7 / 114 (6.14%)
    4 / 113 (3.54%)
         occurrences all number
    8
    4
    Salivary hypersecretion
         subjects affected / exposed
    2 / 114 (1.75%)
    5 / 113 (4.42%)
         occurrences all number
    2
    6
    Tongue disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 114 (0.88%)
    8 / 113 (7.08%)
         occurrences all number
    1
    9
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    2
    Seborrhoea
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    3
    Muscle rigidity
         subjects affected / exposed
    3 / 114 (2.63%)
    7 / 113 (6.19%)
         occurrences all number
    4
    8
    Muscle tightness
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Neck pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Trismus
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 113 (1.77%)
         occurrences all number
    1
    2
    Cystitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 113 (0.88%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 114 (4.39%)
    5 / 113 (4.42%)
         occurrences all number
    5
    6
    Respiratory tract infection
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 113 (0.00%)
         occurrences all number
    2
    0
    Tooth abscess
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 114 (5.26%)
    2 / 113 (1.77%)
         occurrences all number
    6
    2
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 113 (0.00%)
         occurrences all number
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 113 (1.77%)
         occurrences all number
    0
    2
    Increased appetite
         subjects affected / exposed
    2 / 114 (1.75%)
    2 / 113 (1.77%)
         occurrences all number
    3
    2

    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-Sat Apr 27 20:39:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA