ID

30797

Beschreibung

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

Link

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

Stichworte

Versionen (5)
  1. 20.06.18 20.06.18 - Halim Ugurlu
  2. 13.01.19 13.01.19 -
  3. 17.01.19 17.01.19 -
  4. 18.01.19 18.01.19 - Sarah Riepenhausen
  5. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

20. Juni 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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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

Englisch

Case Report Form-Module Number 1b (IHS Headache Classification)

1 Formulare  
Administrative Information
Beschreibung

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

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

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
Beschreibung

At least 5 attacks fulfilling criteria 2-4

Datentyp

boolean

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

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

Datentyp

text

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

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

Datentyp

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
Beschreibung

D-During headache at least one of the following

Datentyp

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
Beschreibung

(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

Datentyp

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
Beschreibung

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
Beschreibung

A-At least 2 attacks fulfilling criteria B-D

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

C-At least two of the following:

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

(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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1546988
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0012634
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Ähnliche Modelle

Case Report Form-Module Number 1b (IHS Headache Classification)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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