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    Clinical Trial Results:
    A Double-Blind, Efficacy and Safety Study of Duloxetine versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder

    Summary
    EudraCT number
    		 2008-006492-71
    Trial protocol
    		 FI   EE   SK   DE   FR  
    Global end of trial date
    13 Oct 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Sep 2017
    First version publication date
    14 Dec 2016
    Other versions
    		 v1
    Version creation reason
    Summary report(s)
    		 HMCK-Approved CSR

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    F1J-MC-HMCK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00849901
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 6223
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 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
    United States: 140
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Slovakia: 6
    Country: Number of subjects enrolled
    Ukraine: 66
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    South Africa: 67
    Worldwide total number of subjects
    337
    EEA total number of subjects
    24
    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)
    135
    Adolescents (12-17 years)
    202
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.

    Period 1
    Period 1 title
    Acute Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duloxetine
    Arm description
    		 Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    LY248686; Cymbalta
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60, 90, and/or 120 milligram (mg) of duloxetine capsules were given orally (PO).

    Arm title
    		 Fluoxetine
    Arm description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluoxetine
    Investigational medicinal product code
    Other name
    Prozac
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 and/or 40 mg of fluoxetine capsules administered orally.

    Arm title
    		 Placebo
    Arm description
    		 Received placebo PO, QD during acute treatment phase
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of placebo was given orally.

    Number of subjects in period 1
    		Duloxetine Fluoxetine Placebo
    Started
    117
    117
    103
    Completed
    87
    91
    87
    Not completed
    30
    26
    16
         Consent withdrawn by subject
    4
    10
    4
         Physician decision
    1
    1
    1
         Adverse event, non-fatal
    9
    1
    3
         Sponsor Decision
    1
    -
    -
         Parent or Caregiver Decision
    11
    5
    4
         Lost to follow-up
    2
    4
    1
         Lack of efficacy
    2
    3
    2
         Protocol deviation
    -
    2
    1
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duloxetine/Duloxetine
    Arm description
    		 Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    LY248686; Cymbalta
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60, 90, and/or 120 milligram (mg) of duloxetine capsules was given orally.

    Arm title
    		 Fluoxetine/Fluoxetine
    Arm description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluoxetine
    Investigational medicinal product code
    Other name
    Prozac
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 and/or 40 mg of fluoxetine capsules was given orally.

    Arm title
    		 Placebo/Duloxetine
    Arm description
    		 Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo/Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo PO, QD was given during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase.

    Number of subjects in period 2 [1]
    		Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Started
    83
    91
    86
    Completed
    56
    65
    69
    Not completed
    27
    26
    17
         Consent withdrawn by subject
    7
    6
    3
         Physician decision
    1
    2
    -
         Adverse event, non-fatal
    2
    8
    4
         Parent or Caregiver Decision
    10
    4
    4
         Lost to follow-up
    3
    -
    1
         Protocol deviation
    2
    2
    4
         Lack of efficacy
    2
    4
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 4 participants from Duloxetine/Duloxetine group and 1 participant from Placebo/Duloxetine group decided not to enter in to the extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Duloxetine
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase.

    Reporting group title
    Fluoxetine
    Reporting group description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Received placebo PO, QD during acute treatment phase

    Reporting group values
    		 Duloxetine Fluoxetine Placebo Total
    Number of subjects
    		 117 117 103 337
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.14 ± 3.043 13.08 ± 3.272 13.28 ± 3.055 -
    Gender, Male/Female
    Units:
        Female
    		 64 61 51 176
        Male
    		 53 56 52 161
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 1 3
        Asian
    		 0 2 0 2
        Black or African American
    		 17 9 13 39
        White
    		 90 93 79 262
        Multiracial
    		 4 7 5 16
        Not Provided
    		 5 5 5 15
    Region of Enrollment
    Units: Subjects
        United States
    		 50 45 45 140
        Finland
    		 1 4 0 5
        France
    		 3 2 3 8
        Germany
    		 1 1 2 4
        Slovakia
    		 2 3 1 6
        Ukraine
    		 25 23 18 66
        Russian Federation
    		 13 15 12 40
        Estonia
    		 1 0 0 1
        South Africa
    		 21 24 22 67
    Clinical Global Impressions of Severity (CGI-Severity) score
    CGI-Severity score evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 4.5 ± 0.62 4.5 ± 0.58 4.6 ± 0.65 -
    Children's Depression Rating Scale-Revised (CDRS-R) Total Score
    CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 59.2 ± 10.45 58.8 ± 10.56 60.2 ± 11.67 -
    CDRS-R Subscale Scores, Mood
    CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 16.3 ± 3.54 15.9 ± 3.85 16.1 ± 3.59 -
    CDRS-R Subscale Scores, Somatic
    CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 19.8 ± 4.54 19.7 ± 4.21 20 ± 4.75 -
    CDRS-R Subscale Scores, Subjective
    CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 10.1 ± 3.08 10.4 ± 3.24 10.4 ± 3.46 -
    CDRS-R Subscale Scores, Behavior
    CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 13 ± 2.79 12.8 ± 2.87 13.5 ± 3 -

    End points

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    End points reporting groups
    Reporting group title
    Duloxetine
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase.

    Reporting group title
    Fluoxetine
    Reporting group description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Received placebo PO, QD during acute treatment phase
    Reporting group title
    Duloxetine/Duloxetine
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase

    Reporting group title
    Fluoxetine/Fluoxetine
    Reporting group description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase

    Reporting group title
    Placebo/Duloxetine
    Reporting group description
    		 Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

    Primary: Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) total score at week 10 endpoint

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    End point title
    		 Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) total score at week 10 endpoint
    End point description
    CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. Analysis Population Description: Participants with both a baseline and at least one post-baseline value.
    End point type
    Primary
    End point timeframe
    Baseline, Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    113
    113
    103
    Units: units on a scale
        least squares mean (standard error)
    -24.3 ± 1.09
    -23.7 ± 1.06
    -24.3 ± 1.11
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Duloxetine
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.999
    Method
    		 Mixed models analysis
    Confidence interval
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 3

    Secondary: Change from week 10 in Children's Depression Rating Scale-Revised (CDRS-R) total score at week 36 endpoint

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    End point title
    		 Change from week 10 in Children's Depression Rating Scale-Revised (CDRS-R) total score at week 36 endpoint
    End point description
    CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. Analysis Population Description: Participants with value during treatment phase and at least one post-Week 10 value.
    End point type
    Secondary
    End point timeframe
    Week 10, Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    81
    91
    85
    Units: units on a scale
        least squares mean (standard deviation)
    -7.2 ± 0.86
    -9.9 ± 0.72
    -9.6 ± 0.86
    No statistical analyses for this end point

    Secondary: Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) subscale score at week 10 endpoint

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    End point title
    		 Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) subscale score at week 10 endpoint
    End point description
    CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. Analysis Population Description: Participants with both a baseline and at least one post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    113
    113
    103
    Units: units on a scale
    least squares mean (standard error)
        Mood (N=113, 113, 103)
    -7 ± 0.36
    -7.1 ± 0.35
    -7 ± 0.37
        Somatic (N=113, 113, 103)
    -7.7 ± 0.42
    -7.6 ± 0.41
    -7.7 ± 0.42
        Subjective (N=113, 113, 103)
    -4 ± 0.23
    -3.6 ± 0.22
    -4 ± 0.23
        Behavior (N=113, 112, 103)
    -5.6 ± 0.3
    -5.4 ± 0.3
    -5.7 ± 0.31
    No statistical analyses for this end point

    Secondary: Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint

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    End point title
    		 Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint
    End point description
    CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. Analysis Population Description: Participants with value during treatment phase and at least one post-Week 10 value.
    End point type
    Secondary
    End point timeframe
    Week 10, Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    81
    91
    85
    Units: units on a scale
    least squares mean (standard error)
        Mood
    -1.9 ± 0.34
    -2.5 ± 0.24
    -2.9 ± 0.29
        Somatic
    -2.8 ± 0.35
    -3.6 ± 0.27
    -3.2 ± 0.33
        Subjective
    -0.3 ± 0.24
    -1.3 ± 0.13
    -1.2 ± 0.17
        Behavior
    -1.9 ± 0.23
    -2.8 ± 0.2
    -2.1 ± 0.36
    No statistical analyses for this end point

    Secondary: Change from baseline in Clinical Global Impressions of Severity (CGI-Severity) scale at week 10 endpoint

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    End point title
    		 Change from baseline in Clinical Global Impressions of Severity (CGI-Severity) scale at week 10 endpoint
    End point description
    CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit. Analysis Population Description: Participants with both a baseline and at least one post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    113
    113
    103
    Units: units on a scale
        least squares mean (standard error)
    -1.9 ± 0.11
    -1.8 ± 0.1
    -1.9 ± 0.11
    No statistical analyses for this end point

    Secondary: Change from Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at week 36 endpoint

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    End point title
    		 Change from Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at week 36 endpoint
    End point description
    CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit. Analysis Population Description: Participants with value during treatment phase and at least one post-Week 10 value.
    End point type
    Secondary
    End point timeframe
    Week 10, Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    81
    91
    85
    Units: units on a scale
        least squares mean (standard error)
    -0.6 ± 0.12
    -1 ± 0.07
    -1.1 ± 0.1
    No statistical analyses for this end point

    Secondary: Number of participants with suicidal ideation or suicidal behavior baseline through week 10

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    End point title
    		 Number of participants with suicidal ideation or suicidal behavior baseline through week 10
    End point description
    Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0). Analysis Population Description: Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    113
    113
    103
    Units: participants
    number (not applicable)
        Suicidal Ideation
    16
    16
    15
        Suicidal Behavior
    0
    1
    0
        Treatment Emergent Suicidal Ideation
    8
    9
    7
    No statistical analyses for this end point

    Secondary: Number of participants with suicidal ideation or suicidal behavior week 10 through week 36

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    End point title
    		 Number of participants with suicidal ideation or suicidal behavior week 10 through week 36
    End point description
    Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10). Analysis Population Description: Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.
    End point type
    Secondary
    End point timeframe
    Week 10 through Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    81
    91
    85
    Units: participants
    number (not applicable)
        Suicidal Ideation
    13
    13
    8
        Suicidal Behavior
    1
    1
    0
        Treatment Emergent Suicidal Ideation
    9
    13
    8
    No statistical analyses for this end point

    Secondary: Number of participants with potentially clinically significant hepatic laboratory results any time baseline through week 10

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    End point title
    		 Number of participants with potentially clinically significant hepatic laboratory results any time baseline through week 10
    End point description
    Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. Analysis Population Description: Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    101
    102
    94
    Units: participants
    number (not applicable)
        ALT≥3 x ULN
    0
    0
    0
        ALT≥5 x ULN
    0
    0
    0
        ALT≥10 x ULN
    0
    0
    0
        ALT≥3 x ULN and Total Bilirubin≥2 x ULN
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with potentially clinically significant hepatic laboratory results any time week 10 through week 36

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    End point title
    		 Number of participants with potentially clinically significant hepatic laboratory results any time week 10 through week 36
    End point description
    Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN. Analysis Population Description: Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.
    End point type
    Secondary
    End point timeframe
    Week 10 through Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    77
    83
    82
    Units: participants
    number (not applicable)
        ALT≥3 x ULN
    0
    1
    0
        ALT≥5 x ULN
    0
    1
    0
        ALT≥10 x ULN
    0
    0
    0
        ALT≥3 x ULN and Total Bilirubin≥2 x ULN
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with potentially clinically significant (PCS) changes in systolic blood pressure (BP), diastolic BP, pulse, and weight any time baseline through week 10

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    End point title
    		 Percentage of participants with potentially clinically significant (PCS) changes in systolic blood pressure (BP), diastolic BP, pulse, and weight any time baseline through week 10
    End point description
    PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. Analysis Population Description: Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 10
    End point values
    		 Duloxetine Fluoxetine Placebo
    Number of subjects analysed
    117
    117
    103
    Units: percentage of participants
    number (not applicable)
        Diastolic BP Increase (N=102, 106, 93)
    8.8
    7.5
    17.2
        Systolic BP Increase (N=100, 106, 90)
    7
    5.7
    6.7
        Pulse Decrease (N=111, 112, 102)
    0.9
    0.9
    1
        Pulse Increase (N=113, 114, 103)
    0
    0
    1
        Weight Decrease (N=113, 114, 103)
    12.4
    11.4
    4.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with potentially clinically significant (PCS) changes in systolic blood pressure (BP), diastolic BP, pulse, and weight any time week 10 through week 36

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    End point title
    		 Percentage of participants with potentially clinically significant (PCS) changes in systolic blood pressure (BP), diastolic BP, pulse, and weight any time week 10 through week 36
    End point description
    PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value. Analysis Population Description: Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.
    End point type
    Secondary
    End point timeframe
    Week 10 through Week 36
    End point values
    		 Duloxetine/Duloxetine Fluoxetine/Fluoxetine Placebo/Duloxetine
    Number of subjects analysed
    83
    91
    86
    Units: percentage of participants
    number (not applicable)
        Diastolic BP Increase (N=65, 76, 61)
    16.9
    11.8
    4.9
        Systolic BP Increase (N=64, 80, 69)
    12.5
    12.5
    10.1
        Pulse Decrease (N=78, 84, 82)
    0
    0
    0
        Pulse Increase (N=81, 91, 84)
    0
    0
    0
        Weight Decrease (N=81, 91, 85)
    6.2
    3.3
    9.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    38 Weeks
    Adverse event reporting additional description
    F1J-MC-HMCK
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo_Acute
    Reporting group description
    		 Received placebo PO, QD during acute treatment phase

    Reporting group title
    Fluoxetine_Acute
    Reporting group description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase

    Reporting group title
    Duloxetine_Acute
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase

    Reporting group title
    Placebo/Duloxetine_Extension
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

    Reporting group title
    Fluoxetine_Extension
    Reporting group description
    		 Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).

    Reporting group title
    Duloxetine_Extension
    Reporting group description
    		 Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase

    Serious adverse events
    		 Placebo_Acute Fluoxetine_Acute Duloxetine_Acute Placebo/Duloxetine_Extension Fluoxetine_Extension Duloxetine_Extension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 103 (0.97%)
    2 / 117 (1.71%)
    3 / 117 (2.56%)
    4 / 86 (4.65%)
    4 / 92 (4.35%)
    1 / 83 (1.20%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    intentional overdose
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ulna fracture
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 117 (0.85%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    convulsion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epilepsy
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    1 / 117 (0.85%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    lymphadenitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 117 (0.85%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 117 (0.85%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    adjustment disorder with disturbance of conduct
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    conversion disorder
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    drug abuse
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    1 / 117 (0.85%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypomania
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    major depression
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    panic attack
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    1 / 117 (0.85%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    restlessness
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social anxiety disorder
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    1 / 117 (0.85%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    1 / 92 (1.09%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    pilonidal cyst
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 86 (0.00%)
    0 / 92 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Placebo_Acute Fluoxetine_Acute Duloxetine_Acute Placebo/Duloxetine_Extension Fluoxetine_Extension Duloxetine_Extension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 103 (66.02%)
    72 / 117 (61.54%)
    70 / 117 (59.83%)
    60 / 86 (69.77%)
    56 / 92 (60.87%)
    53 / 83 (63.86%)
    Injury, poisoning and procedural complications
    incorrect dose administered
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 103 (2.91%)
    4 / 117 (3.42%)
    2 / 117 (1.71%)
    0 / 86 (0.00%)
    3 / 92 (3.26%)
    4 / 83 (4.82%)
         occurrences all number
    3
    5
    2
    0
    3
    5
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 103 (2.91%)
    4 / 117 (3.42%)
    10 / 117 (8.55%)
    6 / 86 (6.98%)
    3 / 92 (3.26%)
    3 / 83 (3.61%)
         occurrences all number
    3
    4
    11
    6
    3
    3
    headache
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    9 / 103 (8.74%)
    18 / 117 (15.38%)
    19 / 117 (16.24%)
    10 / 86 (11.63%)
    9 / 92 (9.78%)
    9 / 83 (10.84%)
         occurrences all number
    10
    22
    23
    12
    10
    10
    Somnolence
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    6 / 103 (5.83%)
    6 / 117 (5.13%)
    7 / 117 (5.98%)
    3 / 86 (3.49%)
    4 / 92 (4.35%)
    2 / 83 (2.41%)
         occurrences all number
    6
    6
    7
    4
    5
    2
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 103 (4.85%)
    3 / 117 (2.56%)
    8 / 117 (6.84%)
    4 / 86 (4.65%)
    3 / 92 (3.26%)
    1 / 83 (1.20%)
         occurrences all number
    5
    5
    8
    4
    3
    1
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    7 / 103 (6.80%)
    5 / 117 (4.27%)
    4 / 117 (3.42%)
    7 / 86 (8.14%)
    2 / 92 (2.17%)
    1 / 83 (1.20%)
         occurrences all number
    8
    7
    4
    7
    2
    1
    diarrhoea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 103 (1.94%)
    2 / 117 (1.71%)
    6 / 117 (5.13%)
    2 / 86 (2.33%)
    4 / 92 (4.35%)
    3 / 83 (3.61%)
         occurrences all number
    2
    2
    6
    2
    4
    3
    nausea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    11 / 103 (10.68%)
    15 / 117 (12.82%)
    20 / 117 (17.09%)
    12 / 86 (13.95%)
    7 / 92 (7.61%)
    3 / 83 (3.61%)
         occurrences all number
    14
    17
    28
    17
    8
    6
    vomiting
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 103 (2.91%)
    6 / 117 (5.13%)
    7 / 117 (5.98%)
    8 / 86 (9.30%)
    5 / 92 (5.43%)
    4 / 83 (4.82%)
         occurrences all number
    3
    7
    7
    9
    5
    5
    Abdominal pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 103 (4.85%)
    2 / 117 (1.71%)
    1 / 117 (0.85%)
    1 / 86 (1.16%)
    2 / 92 (2.17%)
    1 / 83 (1.20%)
         occurrences all number
    5
    2
    1
    1
    2
    1
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 103 (1.94%)
    6 / 117 (5.13%)
    6 / 117 (5.13%)
    1 / 86 (1.16%)
    0 / 92 (0.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    6
    8
    1
    0
    0
    Infections and infestations
    influenza
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    6 / 103 (5.83%)
    3 / 117 (2.56%)
    7 / 117 (5.98%)
    4 / 86 (4.65%)
    3 / 92 (3.26%)
    5 / 83 (6.02%)
         occurrences all number
    8
    3
    7
    4
    3
    6
    Nasopharyngitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 103 (4.85%)
    4 / 117 (3.42%)
    2 / 117 (1.71%)
    9 / 86 (10.47%)
    8 / 92 (8.70%)
    9 / 83 (10.84%)
         occurrences all number
    5
    4
    2
    9
    12
    9
    sinusitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 103 (2.91%)
    1 / 117 (0.85%)
    1 / 117 (0.85%)
    1 / 86 (1.16%)
    1 / 92 (1.09%)
    4 / 83 (4.82%)
         occurrences all number
    3
    1
    1
    1
    1
    4
    upper respiratory tract infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 103 (0.97%)
    3 / 117 (2.56%)
    4 / 117 (3.42%)
    3 / 86 (3.49%)
    5 / 92 (5.43%)
    5 / 83 (6.02%)
         occurrences all number
    1
    3
    4
    3
    7
    6
    Gastroenteritis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 103 (1.94%)
    1 / 117 (0.85%)
    0 / 117 (0.00%)
    3 / 86 (3.49%)
    2 / 92 (2.17%)
    4 / 83 (4.82%)
         occurrences all number
    2
    1
    0
    3
    2
    4
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    7 / 103 (6.80%)
    10 / 117 (8.55%)
    10 / 117 (8.55%)
    3 / 86 (3.49%)
    0 / 92 (0.00%)
    2 / 83 (2.41%)
         occurrences all number
    7
    10
    11
    3
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2010
    Changes were made to the statistical analyses sections as agreed upon in consultation with FDA. The parallel changes were made to the Protocol Synopsis and documented in the Amendment Summary.

    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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    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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