ID
44579
Beskrivning
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
Nyckelord
Versioner (3)
- 2018-06-18 2018-06-18 -
- 2018-06-19 2018-06-19 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024
Screening
- StudyEvent: ODM
Beskrivning
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Childbearing potential
Datatyp
text
Alias
- UMLS CUI [1]
- C3831118
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Demography - Geographic Ancestry
Alias
- UMLS CUI-1
- C3841890
Beskrivning
Geographic Ancestry
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Contraceptive Methods
Alias
- UMLS CUI-1
- C0700589
Beskrivning
Check all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
Specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beskrivning
Entry criteria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1516637
Beskrivning
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-3
- C0680251
Beskrivning
Inclusion / Exclusion Criteria
Datatyp
text
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
Beskrivning
Inclusion/Exclusion criteria applies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
- UMLS CUI [3]
- C1552663
Beskrivning
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beskrivning
A subject who is assigned a subject number, but is not randomised has failed screening.
Datatyp
text
Alias
- UMLS CUI [1]
- C1710476
Beskrivning
Screen Failure Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710476
Beskrivning
If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beskrivning
Specify Reason for Screen Failure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Is this casebook ready to sign?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1706256
Beskrivning
Previous Clinical Trial Participation
Alias
- UMLS CUI-1
- C2348568
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Assessment Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Height
Datatyp
text
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
text
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
BMI
Datatyp
text
Måttenheter
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0021430
Beskrivning
informed consent
Datatyp
text
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beskrivning
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datatyp
text
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Beskrivning
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beskrivning
If other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beskrivning
hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C2347029
Beskrivning
Medical conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beskrivning
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-3
- C3846158
Beskrivning
Migraine history
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Beskrivning
Number of migraine attacks
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0332177
Beskrivning
Duration of migraine attack
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0449238
Beskrivning
(... years old)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Beskrivning
Migraine recurrence
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
Beskrivning
Migraine recurrence delay
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C2985752
Beskrivning
Nr of headache episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
Beskrivning
Nr of no headache episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C1298908
Beskrivning
Previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0087111
Beskrivning
Treatment for migraine
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beskrivning
medication for migraine treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0013227
Beskrivning
Other previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Beskrivning
other migraine treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205394
Beskrivning
previous use of medication for migraine treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beskrivning
satisfaction with medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0242428
- UMLS CUI [1,2]
- C0013216
Beskrivning
Prior treatment medication satisfaction questions
Alias
- UMLS CUI-1
- C3476649
Beskrivning
Date of completion
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
medication effectiveness
Datatyp
text
Alias
- UMLS CUI [1]
- C0087113
Beskrivning
medication side effects
Datatyp
text
Alias
- UMLS CUI [1]
- C2984047
Beskrivning
medication satisfaction
Datatyp
text
Alias
- UMLS CUI [1]
- C3476649
Similar models
Screening
- StudyEvent: ODM
(Comment:en)
(Comment:en)
C2585377 (UMLS CUI-2)
(Comment:en)
C3873750 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
C0004764 (UMLS CUI-2)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C0680251 (UMLS CUI-3)
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
C1552663 (UMLS CUI [3])
C1710476 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C0021430 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3846158 (UMLS CUI-3)
C1304680 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C2985752 (UMLS CUI [1,3])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1514463 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])