ID

34060

Description

https://www.gsk-clinicalstudyregister.com/study/101998#rs 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

Link

https://www.gsk-clinicalstudyregister.com/study/101998#rs

Keywords

Versions (5)
  1. 6/20/18 6/20/18 - Halim Ugurlu
  2. 1/13/19 1/13/19 -
  3. 1/17/19 1/17/19 -
  4. 1/18/19 1/18/19 - Sarah Riepenhausen
  5. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

January 13, 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

Headache Classification

1 forms  
Administrative Information
Description

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
IHS Headache Classification-1.1 Migraine without aura (At least 5 attacks fulfilling criteria 1-3)
Description

IHS Headache Classification-1.1 Migraine without aura (At least 5 attacks fulfilling criteria 1-3)

Alias
UMLS CUI-1
C0018681
UMLS CUI-2
C0008902
UMLS CUI-3
C1389175
A-At least 5 attacks fulfilling criteria B-D
Description

At least 5 attacks fulfilling criteria 2-4

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0018681
B-Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated)
Description

B-Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated)

Data type

text

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C1843783
C-Headache has at least two of the following characteristics:
Description

C-Headache has at least two of the following characteristics:

Data type

text

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0205448
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0332282
D-During headache at least one of the following
Description

D-During headache at least one of the following

Data type

text

Alias
UMLS CUI [1,1]
C0205447
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0018681
UMLS CUI [1,5]
C1335499
Not attributed to another disorder²
Description

(2)History and physical and neurological examinations do not suggest another disorder(3), 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

Data type

boolean

Alias
UMLS CUI [1,1]
C1546988
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0012634
IHS Headache Classification-1.2.1 Typical aura with migraine headache
Description

IHS Headache Classification-1.2.1 Typical aura with migraine headache

Alias
UMLS CUI-1
C0018681
UMLS CUI-2
C0008902
UMLS CUI-3
C0154723
A-At least 2 attacks fulfilling criteria B-D
Description

A-At least 2 attacks fulfilling criteria B-D

Data type

boolean

Alias
UMLS CUI [1,1]
C0154723
UMLS CUI [1,2]
C0243161
B-Aura consisting of at least one of the following, but no motor weakness
Description

B-Aura consisting of at least one of the following, but no motor weakness

Data type

text

Alias
UMLS CUI [1,1]
C0154723
UMLS CUI [1,2]
C0205447
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0332282
UMLS CUI [1,5]
C3842094
C-At least two of the following:
Description

C-At least two of the following:

Data type

text

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332282
Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows aura within 60 minutes.
Description

Headache without aura begins during the aura or follows aura within 60 minutes

Data type

boolean

Alias
UMLS CUI [1,1]
C1827190
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0236018
UMLS CUI [2,1]
C1827190
UMLS CUI [2,2]
C0332283
UMLS CUI [2,3]
C3844316
Not attributed to another disorder²
Description

(2)History and physical and neurological examinations do not suggest another disorder(3), 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

Data type

boolean

Alias
UMLS CUI [1,1]
C1546988
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0012634
Migraine History
Description

Migraine History

Alias
UMLS CUI-1
C0149931
What is the average number of migraine attacks the subject typically experienced per 30 day calendar month during the past year?
Description

Number of Migraine Attacks per Month

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1304680
UMLS CUI [1,3]
C0439507
Subject’s age at onset of migraine attacks
Description

Age at Onset of Migraine Attacks

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0206132
What is the average number of days with any kind of headache the subject typically experiences per 30 day calendar month during the past year?
Description

Average Number of Days with Headache per Month

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0556971
What is the average number of days without any kind of headache thesubject typically experiences per 30 day calendar month during the past year?
Description

Days Without Headache per Month

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0556971
Subject Recruitment
Description

Subject Recruitment

Alias
UMLS CUI-1
C0242800
How was the subject recruited for this study?
Description

Subject Recruitment

Data type

integer

Alias
UMLS CUI [1]
C0242800
Specify
Description

if the subject contacted the site in response to some other means

Data type

text

Alias
UMLS CUI [1]
C2348235
Specify
Description

if the site contacted the subject through some other means

Data type

text

Alias
UMLS CUI [1]
C2348235
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Similar models

Headache Classification

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Information
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
IHS Headache Classification-1.1 Migraine without aura (At least 5 attacks fulfilling criteria 1-3)
C0018681 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
C1389175 (UMLS CUI-3)
At least 5 attacks fulfilling criteria 2-4
Item
A-At least 5 attacks fulfilling criteria B-D
boolean
C0243161 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
B-Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated)
Item
B-Headache attacks, lasting 4-72 hours (untreated or unsuccessfully treated)
text
C0018681 (UMLS CUI [1,1])
C1843783 (UMLS CUI [1,2])
Item
C-Headache has at least two of the following characteristics:
text
C0018681 (UMLS CUI [1,1])
C0205448 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C-Headache has at least two of the following characteristics:
Code List
C-Headache has at least two of the following characteristics:
CL Item
Unilateral location. (1)
CL Item
Pulsating quality. (2)
CL Item
Moderate or severe pain intensity. (3)
CL Item
Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs). (4)
Item
D-During headache at least one of the following
text
C0205447 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0018681 (UMLS CUI [1,4])
C1335499 (UMLS CUI [1,5])
D-During headache at least one of the following
Code List
D-During headache at least one of the following
CL Item
Nausea and/or vomiting. (1)
CL Item
Photophobia and phonophobia. (2)
Not attributed to another disorder²
Item
Not attributed to another disorder²
boolean
C1546988 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Item Group
IHS Headache Classification-1.2.1 Typical aura with migraine headache
C0018681 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
C0154723 (UMLS CUI-3)
A-At least 2 attacks fulfilling criteria B-D
Item
A-At least 2 attacks fulfilling criteria B-D
boolean
C0154723 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Item
B-Aura consisting of at least one of the following, but no motor weakness
text
C0154723 (UMLS CUI [1,1])
C0205447 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C3842094 (UMLS CUI [1,5])
B-Aura consisting of at least one of the following, but no motor weakness
Code List
B-Aura consisting of at least one of the following, but no motor weakness
CL Item
Fully reversible visual symptoms including positive features (e.g., flickering light, spots or lines) and/or negative features (i.e., loss of vision). (1)
CL Item
Fully reversible sensory symptoms including positive features (i.e., pins and needles) and/or negative features i.e., numbness). (2)
CL Item
Fully reversible dysphasic speech disturbance. (3)
Item
C-At least two of the following:
text
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C-At least two of the following:
Code List
C-At least two of the following:
CL Item
Homonymous visual symptoms(4) and/or unilateral sensory symptoms. (1)
CL Item
At least one aura symptom develops gradually over ≥5 minutes and/or different aura symptoms occur in succession over ≥5 minutes (2)
CL Item
Each symptom lasts ≥5 and ≤60 minutes (3)
Headache without aura begins during the aura or follows aura within 60 minutes
Item
Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows aura within 60 minutes.
boolean
C1827190 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0236018 (UMLS CUI [1,4])
C1827190 (UMLS CUI [2,1])
C0332283 (UMLS CUI [2,2])
C3844316 (UMLS CUI [2,3])
Not attributed to another disorder²
Item
Not attributed to another disorder²
boolean
C1546988 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Item Group
Migraine History
C0149931 (UMLS CUI-1)
Number of Migraine Attacks per Month
Item
What is the average number of migraine attacks the subject typically experienced per 30 day calendar month during the past year?
integer
C0149931 (UMLS CUI [1,1])
C1304680 (UMLS CUI [1,2])
C0439507 (UMLS CUI [1,3])
Age at Onset of Migraine Attacks
Item
Subject’s age at onset of migraine attacks
integer
C0149931 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
Average Number of Days with Headache per Month
Item
What is the average number of days with any kind of headache the subject typically experiences per 30 day calendar month during the past year?
integer
C0018681 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
Days Without Headache per Month
Item
What is the average number of days without any kind of headache thesubject typically experiences per 30 day calendar month during the past year?
integer
C0018681 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,3])
Item Group
Subject Recruitment
C0242800 (UMLS CUI-1)
Item
How was the subject recruited for this study?
integer
C0242800 (UMLS CUI [1])
Subject Recruitment
Code List
How was the subject recruited for this study?
CL Item
The subject contacted the site in response to a printed, radio, or TV advertisement (1)
CL Item
The subject contacted the site in response to a flyer (2)
CL Item
The subject contacted the site in response to word-of-mouth referral (3)
CL Item
The subject contacted the site in response to referral by another doctor outside this clinic (4)
CL Item
The subject contacted the site in response to some other means (5)
CL Item
Specify (6)
CL Item
The site contacted the subject through retrospective chart review of previous or current patients (7)
CL Item
The site contacted the subject during a visit scheduled for headache (8)
CL Item
The site contacted the subject during a visit scheduled for some other medical reason (9)
CL Item
The site contacted the subject through some other means (10)
Specification
Item
Specify
text
C2348235 (UMLS CUI [1])
Specification
Item
Specify
text
C2348235 (UMLS CUI [1])
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