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.

Keywords

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

GlaxoSmithKline

Uploaded on

January 17, 2019

DOI

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License

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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