ID

34506

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 18, 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
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
IHS Headache Classification
Description

IHS Headache Classification

Alias
UMLS CUI-1
C0018681
UMLS CUI-2
C0008902
UMLS CUI-3
C1389175
Migraine without Aura
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 disorder History and physical and neurological examinations do not suggest another disorder, or history and/or physical and/or neurological examinations do suggest such disorder but it is ruled out by appropriate investigations, such disorder is present but attacks do not occur for the first time in close temporal relation to the disorder. 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]
C1389175
Typical Aura with Migraine Headache
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 symptoms 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 disorder History and physical and neurological examinations do not suggest another disorder, 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. 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. Visual Symptoms: 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
HIT-6: Headache Classification
Description

HIT-6: Headache Classification

Data type

integer

Alias
UMLS CUI [1]
C2964552
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

Measurement units
  • migraines/month
Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1304680
UMLS CUI [1,3]
C0439507
migraines/month
Subject’s age at onset of migraine attacks
Description

Age at Onset of Migraine Attacks

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0206132
years
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

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0556971
days
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

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0556971
days
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
If the subject contacted the site in response to some other means, specify
Description

Reason Subject Contacted the Site Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C2825164
If the site contacted the subject through some other means, specify
Description

Reason the site contacted the Subject Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C0681850
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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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
IHS Headache Classification
C0018681 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
C1389175 (UMLS CUI-3)
Item
Migraine without Aura
text
C1389175 (UMLS CUI [1])
Migraine without Aura
Code List
Migraine without Aura
CL Item
Yes (Y)
CL Item
No (N)
Item
Typical Aura with Migraine Headache
text
C0018681 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0154723 (UMLS CUI [1,3])
Typical Aura with Migraine Headache
Code List
Typical Aura with Migraine Headache
CL Item
Yes (Y)
CL Item
No (N)
HIT-6: Headache Classification
Item
HIT-6: Headache Classification
integer
C2964552 (UMLS CUI [1])
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)
Reason Subject Contacted the Site Specification
Item
If the subject contacted the site in response to some other means, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
Reason the site contacted the Subject Specification
Item
If the site contacted the subject through some other means, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
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