ID
38536
Beschrijving
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
Trefwoorden
Versies (2)
- 22-09-19 22-09-19 -
- 24-10-19 24-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636
Screening
- StudyEvent: ODM
Beschrijving
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschrijving
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Patient 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
Ethnic group
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Your ancestry or national origin
Datatype
text
Alias
- UMLS CUI [1]
- C3841890
Beschrijving
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C0005834
Beschrijving
Pharmacogenetic Test, Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
Beschrijving
Pharmacogenetic Test, Informed Consent, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Beschrijving
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Beschrijving
Pharmacogenetic Test, Informed Consent, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beschrijving
Pharmacogenetic Test, Informed Consent, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Beschrijving
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beschrijving
Pharmacogenetic Test, Informed Consent, Withdraw
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beschrijving
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0011008
Beschrijving
Pharmacogenetic Test, Blood specimen, Destruction, Request
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
Beschrijving
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Beschrijving
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Beschrijving
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Beschrijving
Trial Screen Failure
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710476
Beschrijving
Trial Screen Failure, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschrijving
Trial Screen Failure, Reason and justification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschrijving
Trial Screen Failure, Clinical Study Case, Investigator Signature
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1706256
- UMLS CUI [1,4]
- C2346576
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Eligibility Determination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Inclusion
Datatype
text
Alias
- UMLS CUI [1]
- C1512693
Beschrijving
Exclusion Criteria
Datatype
text
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Status of Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Agent
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant Agent, Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschrijving
Concomitant Agent, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Agent, Medication name, Reported Term
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Beschrijving
Concomitant Agent, Pharmaceutical Preparations, Synonym
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Beschrijving
Concomitant Agent, Code
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Beschrijving
Concomitant Agent, Code, Failed
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschrijving
Concomitant Agent, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Beschrijving
Concomitant Agent, Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body mass index
Datatype
float
Maateenheden
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Systolic Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Systolic Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Systolic Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Systolic Pressure, Low, Average
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beschrijving
Diastolic blood pressure, Low, Average
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
12 lead ECG, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
12 lead ECG, Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beschrijving
12 lead ECG, P-R Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschrijving
12 lead ECG, QRS complex duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschrijving
12 lead ECG, QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschrijving
12 lead ECG, Electrocardiogram QT corrected interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschrijving
12 lead ECG, Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschrijving
12 lead ECG, QRS Axis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Beschrijving
12 lead ECG, RR interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Beschrijving
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Clinical Study Case, Investigator Signature
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Beschrijving
Clinical Study Case, Investigator Signature
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Similar models
Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])