ID

44091

Description

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Keywords

Versions (3)
  1. 6/21/18 6/21/18 -
  2. 6/21/18 6/21/18 -
  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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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

English

Attack 1 Diary

1 forms  
  1. StudyEvent: ODM
    1. Attack 1 Diary
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit/Assessment
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Migraine attack 1 symptoms
Description

Migraine attack 1 symptoms

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C1457887
Enter the date and time your migraine headache pain started
Description

start date migraine attack

Data type

datetime

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0808070
Did you wake up with your migraine headache pain?
Description

woke up with migraine headache pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0442696
UMLS CUI [1,2]
C0149931
UMLS CUI [1,3]
C0018681
Did you have aura?
Description

migraine with aura

Data type

boolean

Alias
UMLS CUI [1]
C0154723
Pain worsened by physical activity?
Description

pain worsened by physical activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C4054844
What best describes the quality of your migraine headache pain?
Description

migraine headache pain quality

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0018681
UMLS CUI [1,3]
C1148406
What best describes the location of your migraine headache pain?
Description

migraine headache pain location

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0018681
UMLS CUI [1,3]
C0030193
UMLS CUI [1,4]
C0450429
Investigational Product
Description

Investigational Product

Start date
Description

Start date

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0808070
DDMONYYYY
Start time
Description

Start time

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
Stop Date
Description

Stop Date

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0806020
DDMONYYYY
Migraine attack 1 headache pain and symptoms
Description

Migraine attack 1 headache pain and symptoms

Alias
UMLS CUI-1
C0149931
UMLS CUI-2
C0018681
UMLS CUI-3
C0030193
UMLS CUI-4
C1457887
Time since drug intake
Description

time since drug intake

Data type

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1512806
How severe is your migraine headache pain?
Description

migraine headache pain with scale

Data type

text

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0018681
UMLS CUI [1,3]
C1504479
Nausea symptoms
Description

Nausea

Data type

boolean

Alias
UMLS CUI [1]
C0027497
Vomiting symptom
Description

Vomiting

Data type

integer

Alias
UMLS CUI [1]
C0042963
Light sensitivity symptom
Description

Light sensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0085636
Sound sensitivity symptom
Description

Sound sensitivity

Data type

boolean

Alias
UMLS CUI [1]
C2938899
Medications taken
Description

Medications taken

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug name (Trade name preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Description

Modified reported term

Data type

text

Alias
UMLS CUI [1]
C2826819
Date and time medication taken
Description

Date and time medication taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Primary Reason Medication Taken
Description

Primary Reason Medication Taken

Data type

text

Specify other reason
Description

Specify other reason

Data type

text

Alias
UMLS CUI [1]
C2826696
Ability to function
Description

Ability to function

Alias
UMLS CUI-1
C0441655
UMLS CUI-2
C0085732
Time since drug intake
Description

time since drug intake

Data type

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1512806
How do you rate your ability to do school work or perform you usual activities?
Description

ability to perform usual activities

Data type

text

Alias
UMLS CUI [1,1]
C0441655
UMLS CUI [1,2]
C0085732
Investigational product accountability
Description

Investigational product accountability

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0078889
Investigational product container numbers assigned
Description

investigational product container number

Data type

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
Total Number of Tablets Dispensed
Description

total number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total Number of Tablets taken
Description

total number of tablets taken

Data type

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1883727
Returned Date
Description

Returned Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0332156
UMLS CUI [1,4]
C0011008
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Total Number of Tablets Returned
Description

total number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date and time of second tablet
Description

Date and time of second tablet

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1264639
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Language used in diary assessment
Description

Language used in diary assessment

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C0023008
ISO language
Description

ISO language

Data type

text

Alias
UMLS CUI [1]
C1708640
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Similar models

Attack 1 Diary

1 forms
  1. StudyEvent: ODM
    1. Attack 1 Diary
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Migraine attack 1 symptoms
C0149931 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
start date migraine attack
Item
Enter the date and time your migraine headache pain started
datetime
C0149931 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
woke up with migraine headache pain
Item
Did you wake up with your migraine headache pain?
boolean
C0442696 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
migraine with aura
Item
Did you have aura?
boolean
C0154723 (UMLS CUI [1])
pain worsened by physical activity
Item
Pain worsened by physical activity?
boolean
C0018681 (UMLS CUI [1,1])
C4054844 (UMLS CUI [1,2])
Item
What best describes the quality of your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C1148406 (UMLS CUI [1,3])
migraine headache pain quality
Code List
What best describes the quality of your migraine headache pain?
CL Item
Pulsing, throbbing, or pounding pain (1)
CL Item
Pressure/tightening (2)
Item
What best describes the location of your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,4])
migraine headache pain quality
Code List
What best describes the location of your migraine headache pain?
CL Item
Only one side of head (1)
CL Item
On both sides of head (2)
Item Group
Investigational Product
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Migraine attack 1 headache pain and symptoms
C0149931 (UMLS CUI-1)
C0018681 (UMLS CUI-2)
C0030193 (UMLS CUI-3)
C1457887 (UMLS CUI-4)
Item
Time since drug intake
text
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
time since drug intake
Code List
Time since drug intake
CL Item
0 hour (at time of dosing) (1)
(Comment:en)
CL Item
1 hour after dose (2)
(Comment:en)
CL Item
2 hous after dose (3)
(Comment:en)
CL Item
4 hours after dose (4)
(Comment:en)
Item
How severe is your migraine headache pain?
text
C0149931 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C1504479 (UMLS CUI [1,3])
migraine headache pain with scale
Code List
How severe is your migraine headache pain?
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Nausea
Item
Nausea symptoms
boolean
C0027497 (UMLS CUI [1])
Vomiting
Item
Vomiting symptom
integer
C0042963 (UMLS CUI [1])
Light sensitivity
Item
Light sensitivity symptom
boolean
C0085636 (UMLS CUI [1])
Sound sensitivity
Item
Sound sensitivity symptom
boolean
C2938899 (UMLS CUI [1])
Item Group
Medications taken
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Date and time medication taken
Item
Date and time medication taken
datetime
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Primary Reason Medication Taken
text
Primary Reason Medication Taken
Code List
Primary Reason Medication Taken
CL Item
Mild Migraine Headache Pain (1)
CL Item
Moderate Migraine Headache Pain (2)
CL Item
Severe Migraine Headache Pain (3)
CL Item
Other Reason, Specify (4)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Ability to function
C0441655 (UMLS CUI-1)
C0085732 (UMLS CUI-2)
Item
Time since drug intake
text
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
time since drug intake
Code List
Time since drug intake
CL Item
0 hour (at time of dosing) (1)
(Comment:en)
CL Item
1 hour after dose (2)
(Comment:en)
CL Item
2 hous after dose (3)
(Comment:en)
CL Item
4 hours after dose (4)
(Comment:en)
Item
How do you rate your ability to do school work or perform you usual activities?
text
C0441655 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
ability to perform usual activities
Code List
How do you rate your ability to do school work or perform you usual activities?
CL Item
Normal (1)
CL Item
Mildly impaired (2)
CL Item
Moderately impaired (3)
CL Item
Severely impaired (4)
CL Item
Required bedrest (5)
Item Group
Investigational product accountability
C0304229 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
investigational product container number
Item
Investigational product container numbers assigned
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
total number of tablets dispensed
Item
Total Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
total number of tablets taken
Item
Total Number of Tablets taken
integer
C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Returned Date
Item
Returned Date
date
C0013227 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Sequence Number
Item
Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
total number of tablets returned
Item
Total Number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date and time of second tablet
Item
Date and time of second tablet
datetime
C0013227 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Language used in diary assessment
C3890583 (UMLS CUI-1)
C0023008 (UMLS CUI-2)
ISO language
Item
ISO language
text
C1708640 (UMLS CUI [1])
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