0 Evaluaciones
ID

41044

Descripción

This form documents the concomitant medications taken during the study. To be filled in continously. 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

Palabras clave

Versiones (1)
  1. 16/6/20 16/6/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de junio de 2020

DOI

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Licencia

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

    Inglés

    Concomitant Medications

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    integer

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

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Concomintant Medications
    Descripción

    Concomintant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Descripción

    Concomitant Agent Drug Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Unit Dose
    Descripción

    Concomitant Agent Unit Dose

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C2826646
    Units
    Descripción

    Concomitant Agent Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0439148
    Frequency
    Descripción

    Concomitant Agent Frequency

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826654
    Route
    Descripción

    Concomitant Agent Drug Administration Routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Reason for Medication
    Descripción

    Concomitant Agent Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    Start Date and Time
    Descripción

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

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C1301880
    Taken Prior to Study?
    Descripción

    Concomitant Agent Taken Prior to Study?

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826667
    Ongoing?
    Descripción

    Concomitant Agent Ongoing

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826666
    End Date and Time
    Descripción

    Hr:Min (00:00-23:59) To be filled in if the angent is not ongoing.

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C1522314
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    Similar models

    Concomitant Medications

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
    Concomintant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Agent Drug Name
    Item
    Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent Unit Dose
    Item
    Unit Dose
    float
    C2826646 (UMLS CUI [1])
    Concomitant Agent Unit
    Item
    Units
    text
    C2347852 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Concomitant Agent Frequency
    Item
    Frequency
    text
    C2826654 (UMLS CUI [1])
    Concomitant Agent Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent Indication
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Agent Start Date Time
    Item
    Start Date and Time
    datetime
    C2347852 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Item
    Taken Prior to Study?
    text
    C2826667 (UMLS CUI [1])
    Concomitant Agent Taken Prior to Study?
    Code List
    Taken Prior to Study?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Ongoing?
    text
    C2826666 (UMLS CUI [1])
    Concomitant Agent Ongoing
    Code List
    Ongoing?
    CL Item
    Yes (Yes)
    CL Item
    No, specify End Date and Time (No, specify End Date and Time)
    Concomitant Agent End Date Time
    Item
    End Date and Time
    datetime
    C2347852 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Volver a la parte superior de la página 

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