0 Evaluaciones
ID

37112

Descripción

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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 Study Indication: Migraine Disorders

Palabras clave

Versiones (1)
  1. 3/7/19 3/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de julio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

    Inglés

    End of Study Record

    1 formularios  
    1. StudyEvent: ODM
      1. End of Study Record
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    End of Study Record
    Descripción

    End of Study Record

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Date of subject completion or discontinuation from the study
    Descripción

    Clinical Trials, End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0806020
    Did the subject become pregnant during the study?
    Descripción

    Pregnancy, During, Clinical Trials

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Did the subject discontinue the study prematurely?
    Descripción

    Continuation status, Clinical Trials

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    If YES, check the primary reason for discontinuation.
    Descripción

    Continuation Status, Clinical Trials, Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Specify
    Descripción

    Continuation Status, Clinical Trials, Reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
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    Similar models

    End of Study Record

    1 formularios
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    End of Study Record
    C0008976 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Clinical Trials, End Date
    Item
    Date of subject completion or discontinuation from the study
    date
    C0008976 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Pregnancy, During, Clinical Trials
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Not applicable (1)
    CL Item
    Yes (2)
    CL Item
    No (3)
    Continuation status, Clinical Trials
    Item
    Did the subject discontinue the study prematurely?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    If YES, check the primary reason for discontinuation.
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation Status, Clinical Trials, Reason
    Code List
    If YES, check the primary reason for discontinuation.
    CL Item
    Adverse event  (1)
    CL Item
    Consent Withdrawn (2)
    CL Item
    Lost to follow up  (3)
    CL Item
    Protocol violation (4)
    CL Item
    Other, specify (5)
    Item
    Specify
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation Status, Clinical Trials, Reason
    Code List
    Specify
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