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    Clinical Trial Results:
    A 6-MONTH, OPEN-LABEL, MULTI-CENTER, FLEXIBLE-DOSE EXTENSION STUDY TO THE B2061014 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE (DVS SR) TABLETS IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

    Summary
    EudraCT number
    2008-002064-34
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    21 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    07 May 2016
    First version publication date
    07 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B2061031
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    3151A6-3357: 3151A6-3357
    Sponsors
    Sponsor organisation name
    10017
    Sponsor organisation address
    235 E 42nd Street, New York, NY, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center,, Pfizer Inc., 01 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 01 18007181021, 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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD) to evaluate safety, tolerability and efficacy of DVS SR.
    Protection of trial subjects
    The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (ICH 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). Evidence of a personally signed and dated informed consent and assent documents indicating that the subject and a legally acceptable representative were informed of all pertinent aspects of the study was required. The investigator was to inform Pfizer immediately of any urgent safety measures taken by the investigator to protect the study subjects against any immediate hazard, and of any serious breaches of this protocol or of ICH GCP that the investigator became aware of.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Mexico: 28
    Country: Number of subjects enrolled
    United States: 240
    Worldwide total number of subjects
    268
    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)
    108
    Adolescents (12-17 years)
    160
    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
    Subjects who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).

    Pre-assignment
    Screening details
    Subjects met all eligibility requirements at the Baseline visit prior to randomization.

    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
    Placebo / DVS SR
    Arm description
    Placebo in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    placebo plus DVS SR flexible dose 20 mg – 50 mg

    Arm title
    Fluoxetine / DVS SR
    Arm description
    Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
    Arm type
    Experimental

    Investigational medicinal product name
    Fluoxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fluoxetine plus DVS SR flexible dose 20 mg – 50 mg

    Arm title
    Desvenlafaxine Succinate Sustained Release / DVS SR
    Arm description
    DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
    Arm type
    Experimental

    Investigational medicinal product name
    Desvenlafaxine Succinate Sustained Release
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Desvenlafaxine Succinate Sustained Release plus DVS SR flexible dose 20 mg – 50 mg

    Number of subjects in period 1
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Started
    87
    89
    92
    Completed
    59
    65
    62
    Not completed
    28
    24
    30
         Protocol deviation
    6
    4
    5
         Lack of efficacy
    2
    4
    3
         Not specified
    2
    3
    -
         Adverse event, non-fatal
    5
    4
    5
         Consent withdrawn by subject
    5
    7
    11
         Lost to follow-up
    8
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo / DVS SR
    Reporting group description
    Placebo in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Fluoxetine / DVS SR
    Reporting group description
    Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Desvenlafaxine Succinate Sustained Release / DVS SR
    Reporting group description
    DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Total
    Number of subjects
    87 89 92 268
    Age categorical
    Units: Subjects
        Children (2-11 years)
    35 38 35 108
        Adolescents (12-17 years)
    52 51 57 160
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    12.5 ± 2.9 12.4 ± 3.01 12.8 ± 3.14 -
    Gender, Male/Female
    Safety population - included all randomized participants who received at least 1 dose of study drug. Total = sum across Arm/Groups = Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031.
    Units: Participants
        Female
    47 39 49 135
        Male
    40 50 43 133

    End points

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    End points reporting groups
    Reporting group title
    Placebo / DVS SR
    Reporting group description
    Placebo in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Fluoxetine / DVS SR
    Reporting group description
    Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Desvenlafaxine Succinate Sustained Release / DVS SR
    Reporting group description
    DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014 / DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Primary: Percentage of Participants Experiencing a Treatment Emergent Adverse Event

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    End point title
    Percentage of Participants Experiencing a Treatment Emergent Adverse Event [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    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: No statistical analyses was planned for this primary endpoint
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    87
    89
    92
    Units: Percentage of Participants
        number (not applicable)
    70.1
    75.3
    73.9
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases

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    End point title
    Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
    End point description
    End point type
    Secondary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    55
    61
    56
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -5.55 ± 10.8
    -6.41 ± 11.5
    -5.32 ± 7.29
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases

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    End point title
    Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
    End point description
    End point type
    Secondary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    55
    61
    56
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -0.78 ± 1.23
    -0.77 ± 1.16
    -0.82 ± 0.92
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26

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    End point title
    Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    55
    61
    56
    Units: Percentage of Participants
        number (not applicable)
    90.9
    93.4
    92.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Remission as Determined by a 'Remission' CDRS-R Score of ≤28 at Week 26 Based on Observed Cases

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    End point title
    Percentage of Participants With Remission as Determined by a 'Remission' CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
    End point description
    End point type
    Secondary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    55
    61
    56
    Units: Percentage of Participants
        number (not applicable)
    74.5
    78.7
    73.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases

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    End point title
    Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
    End point description
    End point type
    Secondary
    End point timeframe
    Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
    End point values
    Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
    Number of subjects analysed
    55
    61
    56
    Units: Percentage of Participants
    number (not applicable)
        Very Much Improved
    63.6
    63.9
    57.1
        Much Improved
    27.3
    29.5
    35.7
        Minimally Improved
    3.6
    3.3
    5.4
        No Change
    3.6
    1.6
    1.8
        Minimally Worse
    0
    1.6
    0
        Much Worse
    1.8
    0
    0
        Very Much Worse
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo / DVS SR
    Reporting group description
    Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Desvenlafaxine Succinate Sustained Release / DVS SR
    Reporting group description
    DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Combination
    Reporting group description
    Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Reporting group title
    Fluoxetine / DVS SR
    Reporting group description
    Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031

    Serious adverse events
    Placebo / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination Fluoxetine / DVS SR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 87 (5.75%)
    3 / 92 (3.26%)
    10 / 268 (3.73%)
    2 / 89 (2.25%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frustration
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritability
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Self injurious behaviour
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 92 (0.00%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 92 (1.09%)
    5 / 268 (1.87%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 92 (1.09%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 92 (1.09%)
    1 / 268 (0.37%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Placebo / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination Fluoxetine / DVS SR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 87 (54.02%)
    62 / 92 (67.39%)
    170 / 268 (63.43%)
    61 / 89 (68.54%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 92 (3.26%)
    5 / 268 (1.87%)
    2 / 89 (2.25%)
         occurrences all number
    0
    4
    6
    2
    Fall
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 92 (2.17%)
    5 / 268 (1.87%)
    3 / 89 (3.37%)
         occurrences all number
    0
    2
    5
    3
    Ligament sprain
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 92 (3.26%)
    5 / 268 (1.87%)
    2 / 89 (2.25%)
         occurrences all number
    0
    3
    6
    3
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 92 (3.26%)
    6 / 268 (2.24%)
    3 / 89 (3.37%)
         occurrences all number
    0
    3
    6
    3
    Weight increased
         subjects affected / exposed
    7 / 87 (8.05%)
    12 / 92 (13.04%)
    30 / 268 (11.19%)
    11 / 89 (12.36%)
         occurrences all number
    7
    12
    30
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 87 (6.90%)
    4 / 92 (4.35%)
    11 / 268 (4.10%)
    1 / 89 (1.12%)
         occurrences all number
    7
    5
    13
    1
    Epistaxis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 92 (1.09%)
    5 / 268 (1.87%)
    3 / 89 (3.37%)
         occurrences all number
    2
    1
    6
    3
    Oropharyngeal pain
         subjects affected / exposed
    6 / 87 (6.90%)
    1 / 92 (1.09%)
    10 / 268 (3.73%)
    3 / 89 (3.37%)
         occurrences all number
    6
    1
    10
    3
    Sinus congestion
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 92 (3.26%)
    3 / 268 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 87 (5.75%)
    8 / 92 (8.70%)
    18 / 268 (6.72%)
    5 / 89 (5.62%)
         occurrences all number
    6
    8
    19
    5
    Headache
         subjects affected / exposed
    12 / 87 (13.79%)
    19 / 92 (20.65%)
    47 / 268 (17.54%)
    16 / 89 (17.98%)
         occurrences all number
    13
    38
    71
    20
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 92 (3.26%)
    8 / 268 (2.99%)
    3 / 89 (3.37%)
         occurrences all number
    2
    3
    8
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 92 (0.00%)
    7 / 268 (2.61%)
    5 / 89 (5.62%)
         occurrences all number
    2
    0
    7
    5
    Irritability
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 92 (2.17%)
    8 / 268 (2.99%)
    3 / 89 (3.37%)
         occurrences all number
    3
    2
    8
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 87 (3.45%)
    3 / 92 (3.26%)
    9 / 268 (3.36%)
    3 / 89 (3.37%)
         occurrences all number
    3
    3
    9
    3
    Abdominal pain upper
         subjects affected / exposed
    7 / 87 (8.05%)
    7 / 92 (7.61%)
    22 / 268 (8.21%)
    8 / 89 (8.99%)
         occurrences all number
    7
    9
    28
    12
    Constipation
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 92 (1.09%)
    6 / 268 (2.24%)
    3 / 89 (3.37%)
         occurrences all number
    4
    1
    8
    3
    Diarrhoea
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 92 (2.17%)
    10 / 268 (3.73%)
    5 / 89 (5.62%)
         occurrences all number
    5
    2
    13
    6
    Dyspepsia
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 92 (3.26%)
    5 / 268 (1.87%)
    0 / 89 (0.00%)
         occurrences all number
    2
    3
    5
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 87 (0.00%)
    3 / 92 (3.26%)
    4 / 268 (1.49%)
    1 / 89 (1.12%)
         occurrences all number
    0
    3
    4
    1
    Nausea
         subjects affected / exposed
    9 / 87 (10.34%)
    8 / 92 (8.70%)
    31 / 268 (11.57%)
    14 / 89 (15.73%)
         occurrences all number
    11
    8
    34
    15
    Vomiting
         subjects affected / exposed
    5 / 87 (5.75%)
    6 / 92 (6.52%)
    20 / 268 (7.46%)
    9 / 89 (10.11%)
         occurrences all number
    5
    6
    21
    10
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 92 (5.43%)
    6 / 268 (2.24%)
    0 / 89 (0.00%)
         occurrences all number
    1
    6
    7
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 92 (3.26%)
    7 / 268 (2.61%)
    2 / 89 (2.25%)
         occurrences all number
    2
    3
    7
    2
    Myalgia
         subjects affected / exposed
    4 / 87 (4.60%)
    2 / 92 (2.17%)
    6 / 268 (2.24%)
    0 / 89 (0.00%)
         occurrences all number
    5
    2
    7
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 92 (3.26%)
    6 / 268 (2.24%)
    2 / 89 (2.25%)
         occurrences all number
    1
    3
    6
    2
    Decreased appetite
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 92 (1.09%)
    5 / 268 (1.87%)
    1 / 89 (1.12%)
         occurrences all number
    3
    1
    5
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 87 (0.00%)
    4 / 92 (4.35%)
    5 / 268 (1.87%)
    1 / 89 (1.12%)
         occurrences all number
    0
    4
    5
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 87 (2.30%)
    2 / 92 (2.17%)
    7 / 268 (2.61%)
    3 / 89 (3.37%)
         occurrences all number
    2
    2
    9
    5
    Gastroenteritis viral
         subjects affected / exposed
    4 / 87 (4.60%)
    5 / 92 (5.43%)
    12 / 268 (4.48%)
    3 / 89 (3.37%)
         occurrences all number
    4
    5
    12
    3
    Influenza
         subjects affected / exposed
    5 / 87 (5.75%)
    1 / 92 (1.09%)
    7 / 268 (2.61%)
    1 / 89 (1.12%)
         occurrences all number
    6
    1
    8
    1
    Nasopharyngitis
         subjects affected / exposed
    11 / 87 (12.64%)
    6 / 92 (6.52%)
    21 / 268 (7.84%)
    4 / 89 (4.49%)
         occurrences all number
    12
    8
    26
    6
    Pharyngitis
         subjects affected / exposed
    1 / 87 (1.15%)
    4 / 92 (4.35%)
    7 / 268 (2.61%)
    2 / 89 (2.25%)
         occurrences all number
    1
    4
    8
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 92 (3.26%)
    7 / 268 (2.61%)
    2 / 89 (2.25%)
         occurrences all number
    2
    4
    8
    2
    Sinusitis
         subjects affected / exposed
    2 / 87 (2.30%)
    3 / 92 (3.26%)
    8 / 268 (2.99%)
    3 / 89 (3.37%)
         occurrences all number
    2
    3
    8
    3
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 87 (8.05%)
    8 / 92 (8.70%)
    24 / 268 (8.96%)
    9 / 89 (10.11%)
         occurrences all number
    7
    9
    26
    10
    Viral infection
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 92 (1.09%)
    4 / 268 (1.49%)
    3 / 89 (3.37%)
         occurrences all number
    0
    1
    4
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2011
    Provided clarification for: dosing rationale, additional labeling on study drug packaging, informed consent text revised, added methaqualone to UDS testing, change in study drug blister packaging, deleted investigational procedures from Prohibited Concomitant Treatment.
    22 May 2013
    Combined / clarified efficacy endpoints. Deleted Final On-Therapy Visit reference. Clarified omission of taper. Updated Schedule of activities: study visit naming conventions and out of window wording; subjects who do not taper wording, comprehensive psychiatric evaluation information collected, risk assessment wording. Inclusion/Exclusion criteria updated: “legally acceptable representative” changed to “legal guardian”, contraception requirements and definition of childbearing were clarified, length of time for post-study contraception was updated. Subjects requiring a prohibited medication to control a medical condition should not be enrolled, suicidal ideation exclusion and history of suicide behavior exclusion since last visit and risk assessment wording. Medication error section was added and protocol sponsor qualified medical personnel section, rater qualifications, and storage requirement text. Permitted and prohibited concomitant treatments were modified. Subject withdrawal to include those who could not comply with scheduled or required procedures, instruction for lost to follow-up subjects, risk assessment wording. Clarified: study visit schedule for subjects that did not taper, Hy's Law criteria, causality assessment definition (AEs), reporting of exposures in utero. Clarification regarding review of available laboratory/ECG results before randomization. Assessments updated : CRF be completed, weight be measured without shoes; requirement to a recommendation for BP measurement timing, additional details for pregnancy testing, fasting status recommendations, microscopic analysis, types of sympathomimetic drugs, provision of guidance materials text and rater requirements / training, requirements for risk assessment and discontinuation, added risk assessment, added vendor information, deleted End of Trial in a Member State section, added the table of diagnostician and rater requirements.

    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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