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ID

34427

Description

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 record any previous treatment for migraine, the subject has taken. It should be filled out at the screening visit.

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Versions (2)
  1. 1/13/19 1/13/19 -
  2. 1/17/19 1/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

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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

    English

    Previous Migraine Treatment

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Previous Migraine Treatment
    Description

    Previous Migraine Treatment

    Alias
    UMLS CUI-1
    C0149931
    UMLS CUI-2
    C1514463
    Medication and Medication Category
    Description

    NSAIDs are not containing naproxen (aspirin, ibuprofen, Advil, Motrin, etc.) Other Prescription NSAIDs are not containing naproxen or COX-2 inhibitors (Relafen, Feldene, Indocinx, Orudis, Voltaren, Daypro, Toradol, etc.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C2826808
    Previous use of Medication(s) for the Acute Treatment of Migraine
    Description

    Tick one for each medication/medication category Currently using: during the past 3 months Used at any time in the past: but not within the past 3 months

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [1,3]
    C0013227
    Was the subject satisfied with the way the medication worked?
    Description

    For any medication used

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0242428
    Best Medication Response
    Description

    Best Medication Response

    Alias
    UMLS CUI-1
    C2986560
    UMLS CUI-2
    C0013227
    Medication/Medication category that worked best for treating the subject’s migraine(s) during the past 3 months
    Description

    tick ONLY ONE medication/medication category

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986560
    UMLS CUI [1,2]
    C0013227
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    Similar models

    Previous Migraine Treatment

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Previous Migraine Treatment
    C0149931 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Item
    Medication and Medication Category
    integer
    C2347852 (UMLS CUI [1])
    C2826808 (UMLS CUI [2])
    Medication and Medication Category
    Code List
    Medication and Medication Category
    CL Item
    Sumatriptan (Imitrex) (1)
    CL Item
    Naratriptan (Amerge) (2)
    CL Item
    Zolmitriptan (Zomig) (3)
    CL Item
    Rizatriptan (Maxalt) (4)
    CL Item
    Almotriptan (Axert) (5)
    CL Item
    Eletriptan (Relpax) (6)
    CL Item
    Frovatriptan (Frova) (7)
    CL Item
    COX-2 inhibitors (Celebrex,Vioxx, etc.) (8)
    CL Item
    OTC naproxen (Aleve, etc.) (9)
    CL Item
    OTC NSAIDS (10)
    CL Item
    Prescription naproxen (Naprosyn, Anaprox, etc.) (11)
    CL Item
    Other Prescription NSAIDS (12)
    Item
    Previous use of Medication(s) for the Acute Treatment of Migraine
    integer
    C0149931 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Previous use of Medication(s) for the Acute Treatment of Migraine
    Code List
    Previous use of Medication(s) for the Acute Treatment of Migraine
    CL Item
    Currently using (1)
    CL Item
    Used at any time in the past (2)
    CL Item
    Never Used (3)
    Item
    Was the subject satisfied with the way the medication worked?
    text
    C1274040 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0242428 (UMLS CUI [1,3])
    Result of Medication Satisfying
    Code List
    Was the subject satisfied with the way the medication worked?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Best Medication Response
    C2986560 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    Item
    Medication/Medication category that worked best for treating the subject’s migraine(s) during the past 3 months
    text
    C2986560 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Best Medication Response
    Code List
    Medication/Medication category that worked best for treating the subject’s migraine(s) during the past 3 months
    CL Item
    Sumatriptan (Imitrex) (1)
    CL Item
    Naratriptan (Amerge) (2)
    CL Item
    Zolmitriptan (Zomig) (3)
    CL Item
    Rizatriptan (Maxalt) (4)
    CL Item
    Almotriptan (Axert) (5)
    CL Item
    Eletriptan (Relpax) (6)
    CL Item
    Frovatriptan (Frova) (7)
    CL Item
    COX-2 inhibitors (Celebrex,Vioxx, etc.) (8)
    CL Item
    OTC naproxen (Aleve, etc.) (9)
    CL Item
    OTC NSAIDS (10)
    CL Item
    Prescription naproxen (Naprosyn, Anaprox, etc.) (11)
    CL Item
    Other Prescription NSAIDS (12)
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