ID
44272
Description
This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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
Keywords
Versions (4)
- 11/2/18 11/2/18 -
- 11/9/18 11/9/18 -
- 1/15/19 1/15/19 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999
Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine
Description
Head Impact Test (HIT-6) Score
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-2
- C1518965
- UMLS CUI-3
- C0034394
- UMLS CUI-4
- C0449820
Description
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-2
- C0008902
Description
Diagnostic criteria: A) At least 5 attacks fulfilling criteria B-D B) Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated) C) Headache has at least two of the following characteristics: 1. Unilateral location. 2. Pulsating quality. 3. Moderate or severe pain intensity. 4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs). D) During headache at least one of the following: 1. Nausea and/or vomiting. 2. Photophobia and phonophobia. E) Not attributed to another disorder2. 2 History and physical and neurological examinations do not suggest another disorder3, or history and/or physical and/or neurological examinations do suggest such disorder but it is ruled out by appropriate investigations, or such disorder is present but attacks do not occur for the first time in close temporal relation to the disorder. 3 Disorders include headache attributed to head and/or neck trauma; cranial or cervical vascular disorder; nonvascular intracranial disorder; substance or its withdrawal; infection; disorder of homeostasis; disorder of cranium, neck, eyes, ears, nose, sinuses, teeth, mouth, or other facial or cranial structures; psychiatric disorder; cranial neuralgias and central causes of facial pain.
Data type
text
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0008902
- UMLS CUI [1,3]
- C1389175
Description
Diagnostic criteria: A) At least 2 attacks fulfilling criteria B-D. B) Aura consisting of at least one of the following, but no motor weakness: 1. Fully reversible visual symptoms including positive features (e.g., flickering light, spots or lines) and/ or negative features (i.e., loss of vision). 2. Fully reversible sensory symptoms including positive features (i.e., pins and needles) and/or negative features (i.e., numbness). 3. Fully reversible dysphasic speech disturbance. C) At least two of the following: 1. Homonymous visual symptoms4 and/or unilateral sensory symptoms. 2. At least one aura symptom develops gradually over ≥5 minutes and/or different aura symptoms occur in succession over ≥5 minutes. 3. Each symptom lasts ≥5 and ≤60 minutes. D) Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows aura within 60 minutes. E) Not attributed to another disorder2. 2 History and physical and neurological examinations do not suggest another disorder3, or history and/or physical and/or neurological examinations do suggest such disorder but it is ruled out by appropriate investigations, or such disorder is present but attacks do not occur for the first time in close temporal relation to the disorder. 3 Disorders include headache attributed to head and/or neck trauma; cranial or cervical vascular disorder; nonvascular intracranial disorder; substance or its withdrawal; infection; disorder of homeostasis; disorder of cranium, neck, eyes, ears, nose, sinuses, teeth, mouth, or other facial or cranial structures; psychiatric disorder; cranial neuralgias and central causes of facial pain. 4 Additional loss or blurring of central vision may occur.
Data type
text
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0008902
- UMLS CUI [1,3]
- C0154723
Description
Migraine History
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Description
Average number of migraine attacks experienced per 30 day calendar month during the past year?
Data type
integer
Measurement units
- migraines
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0332177
Description
Age at onset of migraine attacks
Data type
integer
Measurement units
- years old
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Description
Average number of days with any kind of headache experiences per 30 day calendar month during the past year
Data type
integer
Measurement units
- days
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0556971
Description
Average number of days without any kind of headache experiences per 30 day calendar month during the past year
Data type
integer
Measurement units
- days
Alias
- UMLS CUI [1,1]
- C0556971
- UMLS CUI [1,2]
- C0018681
- UMLS CUI [1,3]
- C0332197
Description
Previous Treatment for Migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Description
Previous use of sumatriptan (Imitrex) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0075632
Description
Previous use of naratriptan (Amerge) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0540623
Description
Previous use of zolmitriptan (Zomig) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0528166
Description
Previous use of rizatriptan (Maxalt) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0297635
Description
Previous use of almotriptan (Axert) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0914729
Description
Previous use of eletriptan (Relpax) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0759933
Description
Previous use of frovatriptan (Frova) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0754647
Description
Previous use of COX-2 inhibitors (Celebrex, Vioxx, etc.) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C1257954
Description
Previous use of OTC naproxen (Aleve, etc.) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0013231
Description
1 aspirin, ibuprofen, Advil, Motrin, etc.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0332300
- UMLS CUI [1,6]
- C0027396
Description
Previous use of prescription naproxen (Naprosyn, Anaprox, etc.) for the acute treatment of migraine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0304227
Description
2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0304227
Description
1 aspirin, ibuprofen, Advil, Motrin, etc. 2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Data type
text
Alias
- UMLS CUI [1,1]
- C0150839
- UMLS CUI [1,2]
- C0149931
Description
Satisfaction with sumatriptan during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0075632
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with naratriptan (Amerge) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0540623
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with rizatriptan during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0297635
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with almotriptan (Axert) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0914729
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with eletriptan (Relpax) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0759933
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with frovatriptan (Frova) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0754647
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with COX-2 inhibitors (Celebrex, Vioxx, etc.) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C1257954
- UMLS CUI [1,4]
- C0242428
Description
Satisfaction with OTC naproxen (Aleve, etc.) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0242428
Description
1 aspirin, ibuprofen, Advil, Motrin, etc.
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0013231
- UMLS CUI [1,5]
- C0332300
- UMLS CUI [1,6]
- C0027396
- UMLS CUI [1,7]
- C0242428
Description
Satisfaction with prescription naproxen (Naprosyn, Anaprox, etc.) during prior migraine therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0027396
- UMLS CUI [1,4]
- C0304227
- UMLS CUI [1,5]
- C0242428
Description
2 Relafen, Feldene, Indocin, Orudis, Voltaren, Daypro, Toradol, etc.
Data type
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0003211
- UMLS CUI [1,4]
- C0304227
- UMLS CUI [1,5]
- C0242428
Similar models
Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine
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C0027396 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C0149931 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
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C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0297635 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0914729 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0759933 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0754647 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C1257954 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C0242428 (UMLS CUI [1,5])
C1514463 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0027396 (UMLS CUI [1,6])
C0242428 (UMLS CUI [1,7])
C1514463 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0304227 (UMLS CUI [1,4])
C0242428 (UMLS CUI [1,5])
C1514463 (UMLS CUI [1,2])
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C0242428 (UMLS CUI [1,5])