ID

44371

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. 10/20/19 10/20/19 -
  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

T1-Diaries

1 forms  
  1. StudyEvent: ODM
    1. T1-Diaries
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit; Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Migraine Diary and study drug taken
Description

Status of Migraine Diary and study drug taken

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C3890583
UMLS CUI-3
C0304229
Did subject complete any migraine diaries or take study drug during this period?
Description

Migraine Disorder, Subject Diary | Experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C3890583
UMLS CUI [2]
C0304229
Migraine Diary Information
Description

Migraine Diary Information

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C3890583
Migraine Diary Number
Description

Migraine Disorder, Subject Diary, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0237753
Date your migraine pain started
Description

Migraine Disorder, Pain, Start Date

Data type

date

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

Migraine Disorder, Pain, Start time

Data type

time

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1301880
Date your migraine pain stopped
Description

Migraine Disorder, Pain, End Date

Data type

date

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

Migraine Disorder, Pain, End Time

Data type

time

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1522314
Study Drug Dose Information
Description

Study Drug Dose Information

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Start Date of Dose
Description

Experimental drug, Dosage, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0808070
Start time of dose
Description

Experimental drug, Dosage, Start time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301880
Status of Medications
Description

Status of Medications

Alias
UMLS CUI-1
C2347852
Were any medications recorded on the In-Clinic Medications Taken Diary?
Description

Concomitant Agent, Clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
Were any medications recorded on the At Home Medications Taken Diary?
Description

Concomitant Agent, Home environment

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
Meds Recorded In-Clinic
Description

Meds Recorded In-Clinic

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0442592
Sequence Number
Description

Concomitant Agent, Clinic, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2348184
Drug Name (Trade Name preferred)
Description

Concomitant Agent, Clinic, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2360065
Modified reported term
Description

Concomitant Agent, Clinic, Medication name, Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2360065
UMLS CUI [1,4]
C2826302
GSK Drug synonym
Description

Concomitant Agent, Clinic, Pharmaceutical Preparations, Synonym

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0871468
GSK Drug Collection code
Description

Concomitant Agent, Clinic, Code

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0805701
Failed coding
Description

Concomitant Agent, Clinic, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Date Taken
Description

Concomitant Agent, Clinic, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0011008
Time Taken
Description

Concomitant Agent, Clinic, Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0040223
Medication Status
Description

Medication Status

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0449438
Migraine Number
Description

Migraine Disorders, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0237753
Were any medications recorded for this Migraine diary?
Description

Migraine Disorders,Subject Diary, Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0013227
Meds Recorded at Home
Description

Meds Recorded at Home

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0442519
Sequence Number
Description

Concomitant Agent, Home environment, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2348184
Drug Name (Trade Name preferred)
Description

Concomitant Agent, Home environment, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2360065
Modified reported term
Description

Concomitant Agent, Home environment, Medication name, Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2360065
UMLS CUI [1,4]
C2826302
GSK Drug synonym
Description

Concomitant Agent, Home environment, Pharmaceutical Preparations, Synonym

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0871468
GSK Drug Collection code
Description

Concomitant Agent, Home environment, Code

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0805701
Failed coding
Description

Concomitant Agent, Home environment, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Date Taken
Description

Concomitant Agent, Home environment, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0011008
Time Taken
Description

Concomitant Agent, Home environment, Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0040223
Travel Log
Description

Travel Log

Alias
UMLS CUI-1
C0040802
Since your last study visit, did you treat a migraine with study medication while traveling outside your home time zone?
Description

Migraine Disorders, Experimental drug, Travel, Time Zone

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0040802
UMLS CUI [1,4]
C2825194
Travel across time zones - Date From
Description

Travel, Time Zone, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0808070
Travel across time zones - Date To
Description

Travel, Time Zone, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0806020
Travel across time zones - Migraine Number
Description

Travel, Time Zone, Migraine Disorders, Numbers

Data type

date

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0149931
UMLS CUI [1,4]
C0237753
Travel across time zones - Did you take any blood pressure measurements associated with this migraine?
Description

Travel, Time Zone, Migraine Disorders, Blood Pressure Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0149931
UMLS CUI [1,4]
C0005824
Travel across time zones - If Yes, did at least 24 hrs elapse between study medication and blood pressure measurements for the migraine attack?
Description

Travel, Time Zone, Migraine Disorders, Blood Pressure Measurement, Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2825194
UMLS CUI [1,3]
C0149931
UMLS CUI [1,4]
C0005824
UMLS CUI [1,5]
C0040223
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Similar models

T1-Diaries

1 forms
  1. StudyEvent: ODM
    1. T1-Diaries
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Status of Migraine Diary and study drug taken
C0149931 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Migraine Disorder, Subject Diary | Experimental drug
Item
Did subject complete any migraine diaries or take study drug during this period?
boolean
C0149931 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2])
Item Group
Migraine Diary Information
C0149931 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Migraine Disorder, Subject Diary, Numbers
Item
Migraine Diary Number
integer
C0149931 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Migraine Disorder, Pain, Start Date
Item
Date your migraine 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 pain started
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Migraine Disorder, Pain, End Date
Item
Date your migraine 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 pain stopped
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
Study Drug Dose Information
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Experimental drug, Dosage, Start Date
Item
Start Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Experimental drug, Dosage, Start time
Item
Start time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
Status of Medications
C2347852 (UMLS CUI-1)
Concomitant Agent, Clinic
Item
Were any medications recorded on the In-Clinic Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
Concomitant Agent, Home environment
Item
Were any medications recorded on the At Home Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
Item Group
Meds Recorded In-Clinic
C2347852 (UMLS CUI-1)
C0442592 (UMLS CUI-2)
Concomitant Agent, Clinic, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2826302 (UMLS CUI [1,4])
Concomitant Agent, Clinic, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
Concomitant Agent, Clinic, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Concomitant Agent, Clinic, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Medication Status
C0304229 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Migraine Disorders, Numbers
Item
Migraine Number
integer
C0149931 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Migraine Disorders,Subject Diary, Pharmaceutical Preparations
Item
Were any medications recorded for this Migraine diary?
boolean
C0149931 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item Group
Meds Recorded at Home
C2347852 (UMLS CUI-1)
C0442519 (UMLS CUI-2)
Concomitant Agent, Home environment, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2826302 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Travel Log
C0040802 (UMLS CUI-1)
Migraine Disorders, Experimental drug, Travel, Time Zone
Item
Since your last study visit, did you treat a migraine with study medication while traveling outside your home time zone?
boolean
C0149931 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0040802 (UMLS CUI [1,3])
C2825194 (UMLS CUI [1,4])
Travel, Time Zone, Start Date
Item
Travel across time zones - Date From
date
C0040802 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Travel, Time Zone, End Date
Item
Travel across time zones - Date To
date
C0040802 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Travel, Time Zone, Migraine Disorders, Numbers
Item
Travel across time zones - Migraine Number
date
C0040802 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Travel, Time Zone, Migraine Disorders, Blood Pressure Measurement
Item
Travel across time zones - Did you take any blood pressure measurements associated with this migraine?
boolean
C0040802 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0005824 (UMLS CUI [1,4])
Travel, Time Zone, Migraine Disorders, Blood Pressure Measurement, Time
Item
Travel across time zones - If Yes, did at least 24 hrs elapse between study medication and blood pressure measurements for the migraine attack?
boolean
C0040802 (UMLS CUI [1,1])
C2825194 (UMLS CUI [1,2])
C0149931 (UMLS CUI [1,3])
C0005824 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
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