ID
44579
Beschrijving
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
Trefwoorden
Versies (3)
- 18-06-18 18-06-18 -
- 19-06-18 19-06-18 -
- 27-09-21 27-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
27 september 2021
DOI
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Licentie
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
Beschrijving
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Childbearing potential
Datatype
text
Alias
- UMLS CUI [1]
- C3831118
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Demography - Geographic Ancestry
Alias
- UMLS CUI-1
- C3841890
Beschrijving
Geographic Ancestry
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Contraceptive Methods
Alias
- UMLS CUI-1
- C0700589
Beschrijving
Check all that apply
Datatype
integer
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
Specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0205394
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Entry criteria
Datatype
boolean
Alias
- UMLS CUI [1]
- C1516637
Beschrijving
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-3
- C0680251
Beschrijving
Inclusion / Exclusion Criteria
Datatype
text
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
Beschrijving
Inclusion/Exclusion criteria applies
Datatype
boolean
Alias
- UMLS CUI [1]
- C1512693
- UMLS CUI [2]
- C0680251
- UMLS CUI [3]
- C1552663
Beschrijving
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beschrijving
A subject who is assigned a subject number, but is not randomised has failed screening.
Datatype
text
Alias
- UMLS CUI [1]
- C1710476
Beschrijving
Screen Failure Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710476
Beschrijving
If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify Reason for Screen Failure
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0392360
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Is this casebook ready to sign?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1706256
Beschrijving
Previous Clinical Trial Participation
Alias
- UMLS CUI-1
- C2348568
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Height
Datatype
text
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
text
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
BMI
Datatype
text
Maateenheden
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0021430
Beschrijving
informed consent
Datatype
text
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschrijving
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=Yes
Datatype
text
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Please specify if "Has blood sample been collected for PGx-Pharmacogenetic Research?"=Yes
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
Beschrijving
Please specify if "Has informed consent been obtained for PGx-Pharmacogenetic Research?"=No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beschrijving
If other, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
- UMLS CUI [1,3]
- C0392360
Beschrijving
hidden
Datatype
text
Alias
- UMLS CUI [1]
- C2347029
Beschrijving
Medical conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschrijving
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
IHS Headache Classification
Alias
- UMLS CUI-1
- C0018681
- UMLS CUI-3
- C3846158
Beschrijving
Migraine history
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0262926
Beschrijving
Number of migraine attacks
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C1304680
- UMLS CUI [1,3]
- C0332177
Beschrijving
Duration of migraine attack
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0449238
Beschrijving
(... years old)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0206132
Beschrijving
Migraine recurrence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
Beschrijving
Migraine recurrence delay
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C2985752
Beschrijving
Nr of headache episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
Beschrijving
Nr of no headache episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C1298908
Beschrijving
Previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C0087111
Beschrijving
Treatment for migraine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beschrijving
medication for migraine treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0013227
Beschrijving
Other previous treatment for migraine
Alias
- UMLS CUI-1
- C0149931
- UMLS CUI-2
- C1514463
Beschrijving
other migraine treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0205394
Beschrijving
previous use of medication for migraine treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149931
- UMLS CUI [1,2]
- C0087111
Beschrijving
satisfaction with medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0242428
- UMLS CUI [1,2]
- C0013216
Beschrijving
Prior treatment medication satisfaction questions
Alias
- UMLS CUI-1
- C3476649
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
medication effectiveness
Datatype
text
Alias
- UMLS CUI [1]
- C0087113
Beschrijving
medication side effects
Datatype
text
Alias
- UMLS CUI [1]
- C2984047
Beschrijving
medication satisfaction
Datatype
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])