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ID

37107

Description

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

Mots-clés

Versions (1)
  1. 03/07/2019 03/07/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

3 juillet 2019

DOI

Pour une demande vous connecter.

Licence

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

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    Concomitant Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Description

    Concomitant Agent, During, Clinical Trials

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Drug (Trade name preferred)
    Description

    Concomitant Agent, Medication name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Dose
    Description

    Concomitant Agent, Medication dose

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3174092
    Units
    Description

    Concomitant Agent, Unit

    Type de données

    text

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

    Concomitant Agent, Frequencies

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0439603
    Route
    Description

    Concomitant Agent, Drug Administration Routes

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Date started
    Description

    Concomitant Medication Start Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826734
    Check if started Pre- study
    Description

    Concomitant Medication Start Date

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826734
    Date stopped
    Description

    Concomitant Medication End Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2826744
    Check if continued Post- study
    Description

    Concomitant Agent, Continuous

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0549178
    Conditions treated/ indication
    Description

    Concomitant Agent, Indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    Was drug administered for an adverse event?
    Description

    Concomitant Agent, Indication, Adverse Event

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C0877248
    Retour au début de la page

    Similar models

    Concomitant Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Agent, During, Clinical Trials
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Concomitant Agent, Medication name
    Item
    Drug (Trade name preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Medication dose
    Item
    Dose
    text
    C2347852 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Concomitant Agent, Unit
    Item
    Units
    text
    C2347852 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Concomitant Agent, Frequencies
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Date started
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication Start Date
    Item
    Check if started Pre- study
    boolean
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    Date stopped
    date
    C2826744 (UMLS CUI [1])
    Concomitant Agent, Continuous
    Item
    Check if continued Post- study
    boolean
    C2347852 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Concomitant Agent, Indication
    Item
    Conditions treated/ indication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Agent, Indication, Adverse Event
    Item
    Was drug administered for an adverse event?
    boolean
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    Retour au début de la page 

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