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34747

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Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects study participation status. It should be filled out at the screening visit.

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versioni (3)
  1. 18/01/19 18/01/19 -
  2. 23/01/19 23/01/19 -
  3. 26/01/19 26/01/19 -
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GlaxoSmithKline

Caricato su

26 gennaio 2019

DOI

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Creative Commons BY-NC 3.0
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    Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998

    Inglese

    Study Participation Status

    1 moduli  
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Descrizione

    Visit Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Randomisation Number
    Descrizione

    Randomisation Number

    Alias
    UMLS CUI-1
    C0034656 (Randomization)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Randomisation Number
    Descrizione

    Record randomisation number.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Investigational Product Container Number
    Descrizione

    Investigational Product Container Number

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI-3
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Investigational Product Container Number
    Descrizione

    Record the identifying number from the investigational product container dispensed at this visit.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI [1,3]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Previous Clinical Trial Participation (Migraine Treatment)
    Descrizione

    Previous Clinical Trial Participation (Migraine Treatment)

    Alias
    UMLS CUI-1
    C2348568 (Study Subject Participation Status)
    UMLS CUI-2
    C0149931 (Migraine Disorders)
    UMLS CUI-3
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Did the subject participate in any other research studies of migraine treatments in the past 3 years?
    Descrizione

    Previous Clinical Trial Participation (Migraine Treatment)

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,3]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    If Yes, record how many research studies.
    Descrizione

    Number of Research Studies

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES
    Descrizione

    PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES

    Alias
    UMLS CUI-1
    C2348568 (Study Subject Participation Status)
    UMLS CUI-2
    C0075632 (sumatriptan)
    SNOMED
    322822007
    UMLS CUI-3
    C0027396 (naproxen)
    SNOMED
    11847009
    Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
    Descrizione

    Previous Study Participation of Sumatriptan/Naproxen

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0075632 (sumatriptan)
    SNOMED
    322822007
    UMLS CUI [1,3]
    C0027396 (naproxen)
    SNOMED
    11847009
    Previous Administrative Data
    Descrizione

    Previous Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    UMLS CUI-2
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    Study Number
    Descrizione

    Study Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Previous Protocol Number
    Descrizione

    Previous Protocol Number

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3274381 (Clinical Trial Registry Identifier)
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    Previous Centre Number
    Descrizione

    Previous Centre Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    UMLS CUI [1,3]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    Previous Subject Number
    Descrizione

    Previous Subject Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
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    Similar models

    Study Participation Status

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Randomisation Number
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Randomisation Number
    Item
    Randomisation Number
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    Investigational Product Container Number
    C0304229 (UMLS CUI-1)
    C0180098 (UMLS CUI-2)
    C0600091 (UMLS CUI-3)
    Investigational Product Container Number
    Item
    Investigational Product Container Number
    integer
    C0304229 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Item Group
    Previous Clinical Trial Participation (Migraine Treatment)
    C2348568 (UMLS CUI-1)
    C0149931 (UMLS CUI-2)
    C0087111 (UMLS CUI-3)
    Item
    Did the subject participate in any other research studies of migraine treatments in the past 3 years?
    text
    C2348568 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Previous Clinical Trial Participation (Migraine Treatment)
    Code List
    Did the subject participate in any other research studies of migraine treatments in the past 3 years?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Number of Research Studies
    Item
    If Yes, record how many research studies.
    integer
    C2348568 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Item Group
    PRIOR PARTICIPATION IN SUMATRIPTAN 85MG / NAPROXEN SODIUM 500MG TABLET STUDIES
    C2348568 (UMLS CUI-1)
    C0075632 (UMLS CUI-2)
    C0027396 (UMLS CUI-3)
    Item
    Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
    text
    C2348568 (UMLS CUI [1,1])
    C0075632 (UMLS CUI [1,2])
    C0027396 (UMLS CUI [1,3])
    Previous Study Participation of Sumatriptan/Naproxen
    Code List
    Did the subject participate in a previous study of sumatriptan 85mg/naproxen sodium 500mg tablets?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Previous Administrative Data
    C1320722 (UMLS CUI-1)
    C0205156 (UMLS CUI-2)
    Item
    Study Number
    integer
    C0008976 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Study Number
    Code List
    Study Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    Item
    Previous Protocol Number
    text
    C3274381 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Previous Protocol Number
    Code List
    Previous Protocol Number
    CL Item
    MT400-104 (MT400-104)
    CL Item
    MT400-204 (MT400-204)
    CL Item
    MT400-301 (MT400-301)
    CL Item
    MT400-302 (MT400-302)
    CL Item
    MT400-303 (MT400-303)
    Previous Centre Number
    Item
    Previous Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    C0205156 (UMLS CUI [1,3])
    Previous Subject Number
    Item
    Previous Subject Number
    integer
    C2348585 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
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