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26527

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Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

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  1. 2017-10-18 2017-10-18 -
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18 oktober 2017

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    7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

    Engelsk Italienska

    Pre-Challenge 1 Surveys and Questionnaires

    1 Formulär  
    Default Itemgroup
    Beskrivning

    Default Itemgroup

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Beskrivning

    Subject number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date & Time
    Beskrivning

    Visit Date Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [1,2]
    C1320304 (Time of visit)
    SNOMED
    406544004
    Surveys and Questionnaires
    Beskrivning

    Surveys and Questionnaires

    Alias
    UMLS CUI-1
    C4042892 (Surveys and Questionnaires)
    Panic Symptom List (PSL III R)
    Beskrivning

    Panic Symptom List (PSL III R)

    Alias
    UMLS CUI-1
    C2945698 (panic symptoms)
    UMLS CUI-2
    C0745732 (List)
    LOINC
    LP204165-7
    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
    Beskrivning

    Copyright

    Datatyp

    text

    VAS-A Visual Analog Scale for Anxiety
    Beskrivning

    VAS-A Visual Analog Scale for Anxiety

    Alias
    UMLS CUI-1
    C3536884 (Visual Analog Scale)
    SNOMED
    273903006
    UMLS CUI-2
    C0003467 (Anxiety)
    SNOMED
    48694002
    LOINC
    MTHU013060
    What is your degree of anxiety?
    Beskrivning

    Anxiety score

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C3483978 (Anxiety score)
    LOINC
    LP150148-7
    Visual Analog Scale for Anxiety
    Beskrivning

    Visual Analog Scale for Anxiety

    Alias
    UMLS CUI-1
    C3536884 (Visual Analog Scale)
    SNOMED
    273903006
    UMLS CUI-2
    C0003467 (Anxiety)
    SNOMED
    48694002
    LOINC
    MTHU013060
    Anxiety score
    Beskrivning

    Anxiety score

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C3483978 (Anxiety score)
    LOINC
    LP150148-7
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    Pre-Challenge 1 Surveys and Questionnaires

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Default Itemgroup
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Visit Date Time
    Item
    Visit Date & Time
    datetime
    C1320303 (UMLS CUI [1,1])
    C1320304 (UMLS CUI [1,2])
    Item Group
    Surveys and Questionnaires
    C4042892 (UMLS CUI-1)
    Item Group
    Panic Symptom List (PSL III R)
    C2945698 (UMLS CUI-1)
    C0745732 (UMLS CUI-2)
    Copyright
    Item
    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
    text
    Item Group
    VAS-A Visual Analog Scale for Anxiety
    C3536884 (UMLS CUI-1)
    C0003467 (UMLS CUI-2)
    Anxiety score
    Item
    What is your degree of anxiety?
    float
    C3483978 (UMLS CUI [1])
    Item Group
    C3536884 (UMLS CUI-1)
    C0003467 (UMLS CUI-2)
    Anxiety score
    Item
    float
    C3483978 (UMLS CUI [1])
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