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ID

37112

Beschreibung

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

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  1. 03.07.19 03.07.19 -
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GlaxoSmithKline

Hochgeladen am

3. Juli 2019

DOI

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

    Englisch

    End of Study Record

    1 Formulare  
    1. StudyEvent: ODM
      1. End of Study Record
    Administrative Data
    Beschreibung

    Administrative Data

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

    Clinical Trial Subject Unique Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    End of Study Record
    Beschreibung

    End of Study Record

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C0444930 (End)
    SNOMED
    261782000
    Date of subject completion or discontinuation from the study
    Beschreibung

    Clinical Trials, End Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Did the subject become pregnant during the study?
    Beschreibung

    Pregnancy, During, Clinical Trials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Did the subject discontinue the study prematurely?
    Beschreibung

    Continuation status, Clinical Trials

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    If YES, check the primary reason for discontinuation.
    Beschreibung

    Continuation Status, Clinical Trials, Reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Specify
    Beschreibung

    Continuation Status, Clinical Trials, Reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
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    Ähnliche Modelle

    End of Study Record

    1 Formulare
    1. StudyEvent: ODM
      1. End of Study Record
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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