ID

44377

Beskrivning

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Nyckelord

Versioner (3)
  1. 2019-10-24 2019-10-24 -
  2. 2019-10-24 2019-10-24 -
  3. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

Engelsk

Subject Migraine Diary - Treatment Period T1

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Study Contact’s Name
Beskrivning

Contact person

Datatyp

text

Alias
UMLS CUI [1]
C0337611
Clinic Telephone Number
Beskrivning

Clinic, Telephone Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0442592
UMLS CUI [1,2]
C1515258
Today’s Clinic Visit Date
Beskrivning

Clinic, Date of visit

Datatyp

date

Alias
UMLS CUI [1,1]
C0442592
UMLS CUI [1,2]
C1320303
Next Scheduled Clinic Visit Date
Beskrivning

Date next clinic visit

Datatyp

date

Alias
UMLS CUI [1]
C2735342
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Study Drug and Migraine Diary
Beskrivning

Study Drug and Migraine Diary

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0149931
UMLS CUI-3
C3890583
Date your migraine headache pain started
Beskrivning

Migraine Disorder, Pain, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0808070
Time your migraine headache pain started
Beskrivning

Migraine Disorder, Pain, Start time

Datatyp

time

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1301880
Time your migraine headache pain started
Beskrivning

Migraine Disorder, Pain, Start time

Datatyp

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1301880
Date you took the study drug
Beskrivning

Experimental drug, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time you took the study drug
Beskrivning

Experimental drug, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Time you took the study drug
Beskrivning

Experimental drug, Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Date your migraine headache pain stopped
Beskrivning

Migraine Disorder, Pain, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0806020
Time your migraine headache pain stopped
Beskrivning

Migraine Disorder, Pain, End time

Datatyp

time

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1522314
Time your migraine headache pain stopped
Beskrivning

Migraine Disorder, Pain, End time

Datatyp

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1522314
Medications Taken Diary
Beskrivning

Medications Taken Diary

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C3890583
Drug Name
Beskrivning

Pharmaceutical Preparations, Subject Diary, Medication name

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C2360065
Date Taken
Beskrivning

Pharmaceutical Preparations, Subject Diary, Date in time, Taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1883727
Time Taken
Beskrivning

Pharmaceutical Preparations, Subject Diary, Time, Taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1883727
Time Taken
Beskrivning

Pharmaceutical Preparations, Subject Diary, Time, Taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1883727
Blood Pressure / Exercise / Migraine Headache Pain Information
Beskrivning

Blood Pressure / Exercise / Migraine Headache Pain Information

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0015259
UMLS CUI-3
C014993
UMLS CUI-4
C1533716
Date Blood Pressure Measurements Taken
Beskrivning

Blood pressure measurement, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0011008
Time Blood Pressure Measurements Taken
Beskrivning

Blood pressure measurement, Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0040223
Did you exercise in the 30 minutes before your blood pressure measurements were taken?
Beskrivning

Blood pressure measurement, Exercise, Before

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0332152
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
Beskrivning

Blood pressure measurement, Migraine Disorders, Symptom intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0149931
UMLS CUI [1,3]
C0518690
Alcohol Use Diary
Beskrivning

Alcohol Use Diary

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C3890583
Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beskrivning

Alcohol consumption, Before, Blood pressure measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005824
Number of Units
Beskrivning

Alcohol consumption, Units, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0237753
Date Consumed
Beskrivning

Alcohol consumption, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0011008
Time Consumed
Beskrivning

Alcohol consumption, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0040223
Time Consumed
Beskrivning

Alcohol consumption, Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0040223
Caffeine Use Diary
Beskrivning

Caffeine Use Diary

Alias
UMLS CUI-1
C2006086
UMLS CUI-2
C3890583
Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beskrivning

Caffeine Use, Before, Blood pressure measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C2006086
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005824
Number of Units
Beskrivning

Caffeine Use, Units, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C2006086
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0237753
Date Consumed
Beskrivning

Caffeine Use, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2006086
UMLS CUI [1,2]
C0011008
Time Consumed
Beskrivning

Caffeine Use, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C2006086
UMLS CUI [1,2]
C0040223
Time Consumed
Beskrivning

Caffeine Use, Time

Datatyp

text

Alias
UMLS CUI [1,1]
C2006086
UMLS CUI [1,2]
C0040223
Smoking/Tobacco Use Diary
Beskrivning

Smoking/Tobacco Use Diary

Alias
UMLS CUI-1
C0543414
UMLS CUI-2
C3890583
Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beskrivning

Tobacco Use, Before, Blood pressure measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005824
Number of Units
Beskrivning

Tobacco Use, Units, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0237753
Date Consumed
Beskrivning

Tobacco Use, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0011008
Time Consumed
Beskrivning

Tobacco Use, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
Time Consumed
Beskrivning

Tobacco Use, Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
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Similar models

Subject Migraine Diary - Treatment Period T1

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Contact person
Item
Study Contact’s Name
text
C0337611 (UMLS CUI [1])
Clinic, Telephone Number
Item
Clinic Telephone Number
integer
C0442592 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Clinic, Date of visit
Item
Today’s Clinic Visit Date
date
C0442592 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Date next clinic visit
Item
Next Scheduled Clinic Visit Date
date
C2735342 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Study Drug and Migraine Diary
C0304229 (UMLS CUI-1)
C0149931 (UMLS CUI-2)
C3890583 (UMLS CUI-3)
Migraine Disorder, Pain, Start Date
Item
Date your migraine headache pain started
date
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Migraine Disorder, Pain, Start time
Item
Time your migraine headache pain started
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Time your migraine headache pain started
text
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Migraine Disorder, Pain, Start time
Code List
Time your migraine headache pain started
CL Item
AM (1)
CL Item
PM (2)
Experimental drug, Date in time
Item
Date you took the study drug
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Experimental drug, Time
Item
Time you took the study drug
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time you took the study drug
text
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Experimental drug, Time
Code List
Time you took the study drug
CL Item
AM (1)
CL Item
PM (2)
Migraine Disorder, Pain, End Date
Item
Date your migraine headache pain stopped
date
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Migraine Disorder, Pain, End time
Item
Time your migraine headache pain stopped
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Time your migraine headache pain stopped
text
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Migraine Disorder, Pain, End time
Code List
Time your migraine headache pain stopped
CL Item
AM (1)
CL Item
PM (2)
Item Group
Medications Taken Diary
C0013227 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Pharmaceutical Preparations, Subject Diary, Medication name
Item
Drug Name
text
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Pharmaceutical Preparations, Subject Diary, Date in time, Taken
Item
Date Taken
date
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Pharmaceutical Preparations, Subject Diary, Time, Taken
Item
Time Taken
time
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Item
Time Taken
text
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Pharmaceutical Preparations, Subject Diary, Time, Taken
Code List
Time Taken
CL Item
AM (1)
CL Item
PM (2)
Item Group
Blood Pressure / Exercise / Migraine Headache Pain Information
C0005823 (UMLS CUI-1)
C0015259 (UMLS CUI-2)
C014993 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Blood pressure measurement, Date in time
Item
Date Blood Pressure Measurements Taken
date
C0005824 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Time Blood Pressure Measurements Taken
text
C0005824 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure measurement, Time
Code List
Time Blood Pressure Measurements Taken
CL Item
AM (1)
CL Item
PM (2)
Blood pressure measurement, Exercise, Before
Item
Did you exercise in the 30 minutes before your blood pressure measurements were taken?
boolean
C0005824 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
text
C0005824 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Blood pressure measurement, Migraine Disorders, Symptom intensity
Code List
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
CL Item
None  (1)
CL Item
Mild  (2)
CL Item
Moderate  (3)
CL Item
Severe (4)
Item Group
Alcohol Use Diary
C0001948 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Alcohol consumption, Before, Blood pressure measurement
Item
Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
boolean
C0001948 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005824 (UMLS CUI [1,3])
Alcohol consumption, Units, Numbers
Item
Number of Units
integer
C0001948 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Alcohol consumption, Date in time
Item
Date Consumed
date
C0001948 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Alcohol consumption, Time
Item
Time Consumed
time
C0001948 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C0001948 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
Item Group
Caffeine Use Diary
C2006086 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Caffeine Use, Before, Blood pressure measurement
Item
Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
text
C2006086 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005824 (UMLS CUI [1,3])
Caffeine Use, Units, Numbers
Item
Number of Units
integer
C2006086 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Caffeine Use, Date in time
Item
Date Consumed
date
C2006086 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Caffeine Use, Time
Item
Time Consumed
time
C2006086 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C2006086 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
Item Group
Smoking/Tobacco Use Diary
C0543414 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Tobacco Use, Before, Blood pressure measurement
Item
Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
text
C0543414 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005824 (UMLS CUI [1,3])
Tobacco Use, Units, Numbers
Item
Number of Units
integer
C0543414 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Tobacco Use, Date in time
Item
Date Consumed
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tobacco Use, Time
Item
Time Consumed
time
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
Tillbaka till toppen 

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