0 Ratings
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

Keywords

Versions (1)
  1. 7/3/19 7/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 2019

DOI

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License

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

    English

    Concomitant Medication

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medications
    Description

    Concomitant Medications

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

    Concomitant Agent, During, Clinical Trials

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Drug (Trade name preferred)
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Dose
    Description

    Concomitant Agent, Medication dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    Units
    Description

    Concomitant Agent, Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439148 (Unit)
    SNOMED
    767525000
    Frequency
    Description

    Concomitant Agent, Frequencies

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    Route
    Description

    Concomitant Agent, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Date started
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Check if started Pre- study
    Description

    Concomitant Medication Start Date

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Date stopped
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    Check if continued Post- study
    Description

    Concomitant Agent, Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    Conditions treated/ indication
    Description

    Concomitant Agent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3146298 (Indication)
    Was drug administered for an adverse event?
    Description

    Concomitant Agent, Indication, Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3146298 (Indication)
    UMLS CUI [1,3]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
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    Similar models

    Concomitant Medication

    1 forms
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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