ID

44381

Description

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

Keywords

Versions (3)
  1. 10/24/19 10/24/19 -
  2. 10/24/19 10/24/19 -
  3. 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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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

English

Subject In-Clinic Diary - Screen

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Today’s Clinic Visit Date
Description

Clinic, Date of visit

Data type

date

Alias
UMLS CUI [1,1]
C0442592
UMLS CUI [1,2]
C1320303
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Medications Taken Diary
Description

Medications Taken Diary

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

Pharmaceutical Preparations, Subject Diary, Medication name

Data type

text

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

Pharmaceutical Preparations, Subject Diary, Date in time, Taken

Data type

date

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

Pharmaceutical Preparations, Subject Diary, Time, Taken

Data type

time

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

Pharmaceutical Preparations, Subject Diary, Time, Taken

Data type

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
Description

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
Description

Blood pressure measurement, Date in time

Data type

date

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

Blood pressure measurement, Time

Data type

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?
Description

Blood pressure measurement, Exercise, Before

Data type

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.
Description

Blood pressure measurement, Migraine Disorders, Symptom intensity

Data type

text

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

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?
Description

Alcohol consumption, Before, Blood pressure measurement

Data type

boolean

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

Alcohol consumption, Units, Numbers

Data type

integer

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

Alcohol consumption, Date in time

Data type

date

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

Alcohol consumption, Time

Data type

time

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

Alcohol consumption, Time

Data type

text

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

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?
Description

Caffeine Use, Before, Blood pressure measurement

Data type

text

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

Caffeine Use, Units, Numbers

Data type

integer

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

Caffeine Use, Date in time

Data type

date

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

Caffeine Use, Time

Data type

time

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

Caffeine Use, Time

Data type

text

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

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?
Description

Tobacco Use, Before, Blood pressure measurement

Data type

text

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

Tobacco Use, Units, Numbers

Data type

integer

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

Tobacco Use, Date in time

Data type

date

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

Tobacco Use, Time

Data type

time

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

Tobacco Use, Time

Data type

text

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

Subject In-Clinic Diary - Screen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinic, Date of visit
Item
Today’s Clinic Visit Date
date
C0442592 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
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)
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