0 Ratings
ID

41050

Description

This form documents the telemetry procedure. To be filled in after telemetry is evaluated. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (1)
  1. 6/16/20 6/16/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 16, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

    English

    Telemetry

    1 forms  
    1. StudyEvent: ODM
      1. Telemetry
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit/assessment
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    DOSING DATE AND TIME
    Description

    DOSING DATE AND TIME

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C1264639
    1. Dosing date/time
    Description

    Dosing Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1264639
    TELEMETRY
    Description

    TELEMETRY

    Alias
    UMLS CUI-1
    C0039451
    2. Start Date and Time of Telemetry
    Description

    Hr:Min (00:00-23:59)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C3897500
    3. Stop Date and Time of Telemetry
    Description

    Hr.Min (00:00-23:59)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C3899266
    4. Result of Telemetry
    Description

    Telemetry Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039451
    UMLS CUI [1,2]
    C1274040
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    Similar models

    Telemetry

    1 forms
    1. StudyEvent: ODM
      1. Telemetry
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    DOSING DATE AND TIME
    C0304229 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C1264639 (UMLS CUI-3)
    Dosing Date/Time
    Item
    1. Dosing date/time
    datetime
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Item Group
    TELEMETRY
    C0039451 (UMLS CUI-1)
    Telemetry Start Date/Time
    Item
    2. Start Date and Time of Telemetry
    datetime
    C0039451 (UMLS CUI [1,1])
    C3897500 (UMLS CUI [1,2])
    Telemetry Stop Date/Time
    Item
    3. Stop Date and Time of Telemetry
    datetime
    C0039451 (UMLS CUI [1,1])
    C3899266 (UMLS CUI [1,2])
    Item
    4. Result of Telemetry
    text
    C0039451 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Telemetry Result
    Code List
    4. Result of Telemetry
    CL Item
    Normal (Normal)
    CL Item
    Abnormal - Not clinically significant (Abnormal - Not clinically significant)
    CL Item
    Abnormal - Clinically significant (Abnormal - Clinically significant)
    CL Item
    No result (No result)
    CL Item
    Unable to evaluate (Unable to evaluate)
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