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ID

31897

Description

This ODM file contains the form to collect data about the substance use of the patient. To be assessed at Day -1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 7, 2018

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License

Creative Commons BY-NC 3.0
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    Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396

    English

    Drug and Alcohol Screen, Urine Cotinine Test

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Type
    Description

    Visit Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3641100
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Drug and Alcohol Screen
    Description

    Drug and Alcohol Screen

    Alias
    UMLS CUI-1
    C0373483
    UMLS CUI-2
    C0038586
    UMLS CUI-3
    C0948726
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1302413
    Time sample taken
    Description

    Time sample taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0040223
    Cocaine
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0009170
    Amphetamines
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0002667
    Benzodiazepines
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005064
    Cannabinoids
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0936079
    UMLS CUI [1,2]
    C0870883
    Opiates
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0376196
    Barbiturates
    Description

    If positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004745
    Alcohol
    Description

    If any of the above are positive, exclude subject from the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0202304
    UMLS CUI [2]
    C0001948
    Laboratory Tests - Urine Cotinine
    Description

    Laboratory Tests - Urine Cotinine

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C1697737
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Results
    Description

    Urine Cotinine test results

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1697737
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    Similar models

    Drug and Alcohol Screen, Urine Cotinine Test

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Visit Type
    integer
    C3641100 (UMLS CUI [1])
    Visit Type
    Code List
    Visit Type
    CL Item
    Day-1 of Period 1 (1)
    CL Item
    Day-1 of Period 2 (2)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Drug and Alcohol Screen
    C0373483 (UMLS CUI-1)
    C0038586 (UMLS CUI-2)
    C0948726 (UMLS CUI-3)
    Date sample taken
    Item
    Date sample taken
    date
    C0005834 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Time sample taken
    Item
    Time sample taken
    time
    C0005834 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Cocaine
    integer
    C0009170 (UMLS CUI [1])
    Cocaine
    Code List
    Cocaine
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Amphetamines
    integer
    C0002667 (UMLS CUI [1])
    Cocaine
    Code List
    Amphetamines
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Benzodiazepines
    integer
    C0005064 (UMLS CUI [1])
    Cocaine
    Code List
    Benzodiazepines
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Cannabinoids
    integer
    C0936079 (UMLS CUI [1,1])
    C0870883 (UMLS CUI [1,2])
    Cocaine
    Code List
    Cannabinoids
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Opiates
    integer
    C0376196 (UMLS CUI [1])
    Cocaine
    Code List
    Opiates
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Barbiturates
    integer
    C0004745 (UMLS CUI [1])
    Cocaine
    Code List
    Barbiturates
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Alcohol
    integer
    C0202304 (UMLS CUI [1])
    C0001948 (UMLS CUI [2])
    Cocaine
    Code List
    Alcohol
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item Group
    Laboratory Tests - Urine Cotinine
    C0022885 (UMLS CUI-1)
    C1697737 (UMLS CUI-2)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Results
    integer
    C1254595 (UMLS CUI [1,1])
    C1697737 (UMLS CUI [1,2])
    Urine Cotinine test results
    Code List
    Results
    CL Item
    Positive (1)
    CL Item
    Negative (2)
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