ID

34061

Beschrijving

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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Versies (2)
  1. 13-01-19 13-01-19 -
  2. 17-01-19 17-01-19 -
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GlaxoSmithKline

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13 januari 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

Engels

Previous Migraine Treatment

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Previous Migraine Treatment
Beschrijving

Previous Migraine Treatment

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

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.

Datatype

integer

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C2826808
Currently using (during the past 3 months)
Beschrijving

Currently Using Medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521116
Used at any time in the past (but not within the past 3 months)
Beschrijving

Used in the Past but not Past 3 Months

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C4086725
UMLS CUI [2,2]
C1272460
Never Used
Beschrijving

Medication Never Used

Datatype

text

Alias
UMLS CUI [1,1]
C2003901
UMLS CUI [1,2]
C0013227
Was the subject satisfied with the way the medication worked?
Beschrijving

For any medication used

Datatype

boolean

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

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
Beschrijving

tick ONLY ONE medication/medication category

Datatype

text

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

Previous Migraine Treatment

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (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)
Currently Using Medication
Item
Currently using (during the past 3 months)
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Used in the Past but not Past 3 Months
Item
Used at any time in the past (but not within the past 3 months)
boolean
C0013227 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C4086725 (UMLS CUI [2,1])
C1272460 (UMLS CUI [2,2])
Medication Never Used
Item
Never Used
text
C2003901 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Result of Medication Satisfying
Item
Was the subject satisfied with the way the medication worked?
boolean
C1274040 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0242428 (UMLS CUI [1,3])
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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