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    Clinical Trial Results:
    6-Month, Multicenter, Open-Label, Flexible-Dose Study To Evaluate Safety, Efficacy, And Tolerability Of Desvenlafaxine Succinate Sustained-Release Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder

    Summary
    EudraCT number
    		 2008-002067-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 May 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2016
    First version publication date
    26 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3151A6-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00669110
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B2061013
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Mar 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the long-term safety and tolerability of Desvenlafaxine succinate sustained-release (DVS SR) in children and adolescents with major depressive disorder (MDD).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2008
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    0
    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)
    20
    Adolescents (12-17 years)
    20
    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
    		 Eligible subjects transitioned from preceding Core study NCT00619619, EudraCT: 2008-002066-57 (3151A6-2000 [B2061012]) on Day 56 to this Extension study NCT00669110, 2008-002067-14 (3151A6-2001 [B2061013]) to continue treatment on a flexible dose schedule. A total of 8 subjects discontinued during Taper/post-study or Follow-up phase of Core study.

    Pre-assignment
    Screening details
    		 Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale -Improvement (CGI-I) and Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DVS SR - Children
    Arm description
    		 Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.

    Arm title
    		 DVS SR - Adolescents
    Arm description
    		 DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

    Number of subjects in period 1
    		DVS SR - Children DVS SR - Adolescents
    Started
    20
    20
    Completed
    12
    7
    Not completed
    8
    13
         Caregiver request
    3
    2
         Physician decision
    -
    1
         Adverse Event
    4
    3
         Withdrawal by Subject
    -
    2
         Protocol Violation
    -
    5
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DVS SR - Children
    Reporting group description
    		 Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.

    Reporting group title
    DVS SR - Adolescents
    Reporting group description
    		 DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

    Reporting group values
    		 DVS SR - Children DVS SR - Adolescents Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.65 ( 1.31 ) 13.55 ( 1.64 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 20
        Male
    		 9 11 20

    End points

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    End points reporting groups
    Reporting group title
    DVS SR - Children
    Reporting group description
    		 Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.

    Reporting group title
    DVS SR - Adolescents
    Reporting group description
    		 DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are ife threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect. Safety population (Baseline=Extension study) includes all treatment assigned subjects with at least 1 dose of study treatment during Extension study NCT00669110.
    End point type
    Primary
    End point timeframe
    Baseline (Extension study) up to Extension study Week 29 Follow up visit
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Adverse Events
    13
    15
        Serious Adverse Events
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

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    End point title
    		 Number of Subjects for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories [2]
    End point description
    C-SSRS is a subjects rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A subjects could have a yes or no response in more than one category. Safety population (Baseline=Core study) includes all treatment assigned subjects with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.
    End point type
    Primary
    End point timeframe
    Postbaseline (greater than equal to [≥] Day 1 in Core study NCT00619619) up to Week 26 (Extension study)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Completed suicide: No
    20
    20
        Suicide attempt: No
    20
    20
        Preparatory acts - imminent suicidal behavior: No
    20
    20
        Suicidal ideation: Yes
    0
    3
        Suicidal ideation: No
    20
    17
        Any suicidal behavior and/or ideation: Yes
    0
    3
        Any suicidal behavior and/or ideation: No
    20
    17
        Self-injurious behavior, no suicidal intent: No
    20
    20
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit

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    End point title
    		 Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit
    End point description
    CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Intent to Treat population (ITT): all treatment assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study), Extension study Outpatient Weeks 26 and greater than (>) Week 26 (up to Week 29 or early termination)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline mean
    32.4 ( 7.61 )
    33.7 ( 6.34 )
        Change from Bsl Outpatient Week 26
    -1.85 ( 5.51 )
    -1.95 ( 6.85 )
        Change from Bsl Outpatient Week >26
    -1.85 ( 5.51 )
    -1.7 ( 6.67 )
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)

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    End point title
    		 Percentage of Subjects With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)
    End point description
    CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1). ITT population and LOCF was used.
    End point type
    Other pre-specified
    End point timeframe
    Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Outpatient Week 1
    26.7
    21.1
        Outpatient Week 2
    30
    25
        Outpatient Week 4
    30
    20
        Outpatient Week 6
    25
    25
        Outpatient Week 10
    45
    25
        Outpatient Week 14
    25
    25
        Outpatient Week 18
    35
    40
        Outpatient Week 22
    30
    35
        Outpatient Week 26
    30
    30
        Outpatient Week >26
    30
    25
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score

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    End point title
    		 Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
    End point description
    HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states. ITT population and LOCF was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline mean
    5.15 ( 3.01 )
    7.45 ( 4.1 )
        Change from Bsl Outpatient Week 1
    0.53 ( 2.72 )
    1.79 ( 2.97 )
        Change from Bsl Outpatient Week 2
    -0.5 ( 2.8 )
    0.7 ( 3.01 )
        Change from Bsl Outpatient Week 4
    -0.4 ( 2.28 )
    -0.95 ( 2.24 )
        Change from Bsl Outpatient Week 6
    -0.45 ( 2.31 )
    -0.7 ( 2.68 )
        Change from Bsl Outpatient Week 10
    -1.3 ( 3.06 )
    -1.4 ( 2.66 )
        Change from Bsl Outpatient Week 14
    -0.45 ( 2.58 )
    -1.65 ( 3.08 )
        Change from Bsl Outpatient Week 18
    -1.65 ( 2.48 )
    -2.45 ( 3.1 )
        Change from Bsl Outpatient Week 22
    -1.05 ( 2.26 )
    -2.15 ( 3.22 )
        Change from Bsl Outpatient Week 26
    -1.65 ( 2.94 )
    -2.35 ( 3.39 )
        Change from Bsl Outpatient Week >26
    -1.65 ( 2.94 )
    -2.1 ( 3.37 )
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score

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    End point title
    		 Percentage of Subjects With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score
    End point description
    CGI-S: 7-point clinician rated scale to assess severity of subject’s current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. ITT population and LOCF was used. No subjects had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.
    End point type
    Other pre-specified
    End point timeframe
    Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Outpatient Week 1: not ill at all
    13.3
    10.5
        Outpatient Week 1: borderline ill
    53.3
    10.5
        Outpatient Week 1: mildly ill
    26.7
    57.9
        Outpatient Week 1: moderately ill
    6.7
    21.1
        Outpatient Week 2: not ill at all
    10
    10
        Outpatient Week 2: borderline ill
    40
    20
        Outpatient Week 2: mildly ill
    45
    45
        Outpatient Week 2: moderately ill
    5
    25
        Outpatient Week 4: not ill at all
    10
    10
        Outpatient Week 4: borderline ill
    50
    30
        Outpatient Week 4: mildly ill
    30
    35
        Outpatient Week 4: moderately ill
    10
    25
        Outpatient Week 6: not ill at all
    10
    10
        Outpatient Week 6: borderline ill
    40
    20
        Outpatient Week 6: mildly ill
    45
    50
        Outpatient Week 6: moderately ill
    5
    20
        Outpatient Week 10: not ill at all
    15
    10
        Outpatient Week 10: borderline ill
    45
    35
        Outpatient Week 10: mildly ill
    35
    45
        Outpatient Week 10: moderately ill
    5
    10
        Outpatient Week 14: not ill at all
    5
    5
        Outpatient Week 14: borderline ill
    55
    55
        Outpatient Week 14: mildly ill
    35
    30
        Outpatient Week 14: moderately ill
    5
    10
        Outpatient Week 18: not ill at all
    5
    5
        Outpatient Week 18: borderline ill
    70
    55
        Outpatient Week 18: mildly ill
    20
    35
        Outpatient Week 18: moderately ill
    5
    5
        Outpatient Week 22: not ill at all
    5
    5
        Outpatient Week 22: borderline ill
    60
    55
        Outpatient Week 22: mildly ill
    30
    35
        Outpatient Week 22: moderately ill
    5
    5
        Outpatient Week 26: not ill at all
    5
    5
        Outpatient Week 26: borderline ill
    75
    50
        Outpatient Week 26: mildly ill
    15
    40
        Outpatient Week 26: moderately ill
    5
    5
        Outpatient Week >26: not ill at all
    5
    5
        Outpatient Week >26: borderline ill
    75
    50
        Outpatient Week >26: mildly ill
    15
    40
        Outpatient Week >26: moderately ill
    5
    5
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score

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    End point title
    		 Percentage of Subjects With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score
    End point description
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3(minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. ITT population and LOCF was used. No subjects had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Outpatient Week 1: very much improved
    25
    10
        Outpatient Week 1: much improved
    55
    45
        Outpatient Week 1: minimally improved
    20
    40
        Outpatient Week 1: minimally worse
    0
    5
        Outpatient Week 2: very much improved
    25
    15
        Outpatient Week 2: much improved
    55
    55
        Outpatient Week 2: minimally improved
    15
    30
        Outpatient Week 4: very much improved
    35
    20
        Outpatient Week 4: much improved
    45
    55
        Outpatient Week 4: minimally improved
    15
    25
        Outpatient Week 4: minimally worse
    5
    0
        Outpatient Week 6: very much improved
    35
    20
        Outpatient Week 6: much improved
    35
    65
        Outpatient Week 6: minimally improved
    30
    15
        Outpatient Week 10: very much improved
    30
    30
        Outpatient Week 10: much improved
    40
    50
        Outpatient Week 10: minimally improved
    30
    15
        Outpatient Week 10: no change
    0
    5
        Outpatient Week 14: very much improved
    25
    40
        Outpatient Week 14: much improved
    50
    40
        Outpatient Week 14: minimally improved
    20
    15
        Outpatient Week 14: no change
    5
    5
        Outpatient Week 18: very much improved
    30
    40
        Outpatient Week 18: much improved
    55
    45
        Outpatient Week 18: minimally improved
    15
    15
        Outpatient Week 22: very much improved
    30
    45
        Outpatient Week 22: much improved
    50
    40
        Outpatient Week 22: minimally improved
    20
    15
        Outpatient Week 26: very much improved
    40
    40
        Outpatient Week 26: much improved
    45
    45
        Outpatient Week 26: minimally improved
    15
    15
        Outpatient Week >26: very much improved
    40
    40
        Outpatient Week >26: much improved
    45
    45
        Outpatient Week >26: minimally improved
    15
    15
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score

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    End point title
    		 Percentage of Subjects With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score
    End point description
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Subject with response is defined as having a score of 1 (very much improved) or 2 (much improved). ITT population and LOCF was used. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: percentage of subjects
    number (not applicable)
        Outpatient Week 1
    80
    55
        Outpatient Week 2
    80
    70
        Outpatient Week 4
    80
    75
        Outpatient Week 6
    70
    85
        Outpatient Week 10
    70
    80
        Outpatient Week 14
    75
    80
        Outpatient Week 18
    85
    85
        Outpatient Week 22
    80
    85
        Outpatient Week 26
    85
    85
        Outpatient Week >26
    85
    85
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Number of Subjects for Tanner Assessment at Week 26: Females

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    End point title
    		 Change From Baseline in Number of Subjects for Tanner Assessment at Week 26: Females
    End point description
    Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Subjects may be represented in more than 1 test category. Safety population (Baseline=Extension study); No subjects had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study), Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    7 [3]
    3 [4]
    Units: subjects
        Breasts: 0=no stage change
    5
    1
        Breasts: 1=change of 1 stage
    1
    1
        Breasts: 2=change of 2 stages
    1
    1
        Pubic hair: 0=no stage change
    6
    2
        Pubic hair: 1=change of 1 stage
    1
    0
        Pubic hair: 2=change of 2 stages
    0
    1
    Notes
    [3] - N=number of subjects with evaluable data at observation.
    [4] - N=number of subjects with evaluable data at observation.
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Number of Subjects for Tanner Assessment at Week 26: Males

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    End point title
    		 Change From Baseline in Number of Subjects for Tanner Assessment at Week 26: Males
    End point description
    Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Subjects may be represented in more than 1 test category. Safety population (Baseline=Extension study; No subjects had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study), Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    5 [5]
    4 [6]
    Units: subjects
        Penis: 0=no stage change
    4
    3
        Penis: 1=change of 1 stage
    1
    0
        Penis: 2=change of 2 stages
    0
    1
        Pubic hair: 0=no stage change
    2
    2
        Pubic hair: 1=change of 1 stage
    3
    1
        Pubic hair: 2=change of 2 stages
    0
    1
        Testes: 0=no stage change
    3
    3
        Testes: 1=change of 1 stage
    2
    0
        Testes: 2=change of 2 stages
    0
    1
    Notes
    [5] - N=number of subjects with evaluable data at observation.
    [6] - N=number of subjects with evaluable data at observation.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)

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    End point title
    		 Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)
    End point description
    PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]). Safety population (Baseline=Extension study).
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Elevated supine SBP, 3 consecutive visits
    4
    0
        Decrease SBP ≥20 mmHg supine to standing
    2
    0
        Decrease DBP ≥15 mmHg supine to standing
    0
    3
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Weight

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    End point title
    		 Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Weight
    End point description
    Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight. Safety population (Baseline=Extension study).
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Increase ≥7 percent in body weight
    11
    4
        Decrease of ≥3.5 percent in body weight
    1
    3
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate

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    End point title
    		 Number of Subjects With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate
    End point description
    PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]). Safety population (Baseline=Extension study).
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Low supine pulse rate
    1
    2
        Increase in pulse rate ≥20 supine to standing
    14
    12
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)

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    End point title
    		 Number of Subjects With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)
    End point description
    ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec; >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula. Safety population (Baseline=Extension study). Subjects may be represented in >1 category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    17 [7]
    14 [8]
    Units: subjects
        PR interval ≥200 msec
    0
    1
        QRS interval ≥120 msec
    0
    1
        QTcF interval ≥30 msec change from baseline
    5
    1
        QTcB interval ≥30 msec change from baseline
    6
    1
        QTcB interval ≥60 msec change from baseline
    1
    0
        QTcB interval >470 or increase ≥60 msec (females)
    1
    0
    Notes
    [7] - N=number of subjects with evaluable data at observation.
    [8] - N=number of subjects with evaluable data at observation.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)

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    End point title
    		 Number of Subjects With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)
    End point description
    PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age). Safety population (Baseline=Extension study).
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    17 [9]
    14 [10]
    Units: subjects
    0
    2
    Notes
    [9] - N=number of subjects with analyzable ECG data.
    [10] - N=number of subjects with analyzable ECG data.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Laboratory Test Results of Potential Clinical Importance (PCI)

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    End point title
    		 Number of Subjects With Laboratory Test Results of Potential Clinical Importance (PCI)
    End point description
    Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter(mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones. Safety population (Baseline=Extension study). Subjects may be represented in >1 category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study) up to Week 26 (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    17 [11]
    14 [12]
    Units: subjects
        Bicarbonate: increase
    2
    0
        Bicarbonate: decrease
    0
    1
        Hematocrit: low
    4
    2
        HDL cholesterol: decrease
    2
    1
        Triglycerides: high
    4
    1
        Urine specific gravity: high
    3
    3
        Urine protein albumin: positive result
    9
    9
        Urine ketones: positive result
    0
    1
        Urine hemoglobin: positive result
    0
    1
    Notes
    [11] - N= number of subjects with analyzable laboratory data.
    [12] - N= number of subjects with analyzable laboratory data.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects for Tanner Assessment: Females

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    End point title
    		 Number of Subjects for Tanner Assessment: Females
    End point description
    Female pubertal development of secondary sexual characteristics documented by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). N=9 Children, 9 Adolescent subjects at observation. Subjects may be represented in more than 1 test category. Safety population (Baseline=Extension study)
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Breasts Stage 1
    4
    0
        Breasts Stage 2
    4
    1
        Breasts Stage 3
    1
    0
        Breasts Stage 4
    0
    1
        Breasts Stage 5
    0
    7
        Pubic hair Stage 1
    6
    6
        Pubic hair Stage 2
    3
    5
        Pubic hair Stage 3
    0
    0
        Pubic hair Stage 4
    0
    2
        Pubic hair Stage 5
    0
    5
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects for Tanner Assessment: Males

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    End point title
    		 Number of Subjects for Tanner Assessment: Males
    End point description
    Male pubertal development of secondary sexual characteristics documented by size of genitalia and pubic hair development (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity, size). N=9 Children, 10 Adolescent subjects at observation. Subjects may be represented in more than 1 test category.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Extension study)
    End point values
    		 DVS SR - Children DVS SR - Adolescents
    Number of subjects analysed
    20
    20
    Units: subjects
        Penis Stage 1
    5
    0
        Penis Stage 2
    3
    2
        Penis Stage 3
    1
    2
        Penis Stage 4
    0
    3
        Penis Stage 5
    0
    3
        Pubic hair Stage 1
    6
    0
        Pubic hair Stage 2
    2
    1
        Pubic hair Stage 3
    1
    3
        Pubic hair Stage 4
    0
    4
        Pubic hair Stage 5
    0
    2
        Testes Stage 1
    5
    0
        Testes Stage 2
    2
    1
        Testes Stage 3
    2
    3
        Testes Stage 4
    0
    3
        Testes Stage 5
    0
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Events collected from the time of the signing of the informed consent form up to Week 29 (Follow up visit)
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non-serious in another, or 1 subject may have experienced both serious, non-serious event during study. EU BR specific AE tables were generated separately as per EU format using latest coding.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    DVS SR Children
    Reporting group description
    		 DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.

    Reporting group title
    DVS SR Adolescents
    Reporting group description
    		 Reporting group description: DVS SR formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

    Serious adverse events
    		 DVS SR Children DVS SR Adolescents
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Negativism
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    		 DVS SR Children DVS SR Adolescents
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    14 / 20 (70.00%)
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Feeling jittery
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    4
    Cough
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    6
    1
    Sinus congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    3
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Depressive symptom
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    4
    Investigations
    Chlamydia test positive
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Heart rate increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    2
    Ligament sprain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Muscle strain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Procedural pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 20 (15.00%)
         occurrences all number
    9
    6
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
    6 / 20 (30.00%)
         occurrences all number
    3
    14
    Syncope
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
         occurrences all number
    3
    5
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    4 / 20 (20.00%)
         occurrences all number
    3
    11
    Vomiting
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    5
    8
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Adenoiditis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Lymph gland infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    4
    Sinusitis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    Tonsillitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2008
    1. The section describing total volume of blood collected was updated from 20 mL to 21 mL based upon information received from the central laboratory. 2. The test article administration section, study flowchart, and procedures section was revised to reflect that the first dose of test article for study 3151A6-2001-US was to be administered on study day 1, the day after the baseline visit.
    14 Apr 2009
    The protocol was updated to allow for an expansion of the flexible dose ranges for each age stratum (children and adolescents).

    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
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