ID

37517

Beskrivning

Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Nyckelord

Versioner (1)
  1. 2019-08-04 2019-08-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 augusti 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625

Engelsk

Screen - Demography; Vital Signs

1 Formulär  
Inform Screening
Beskrivning

Inform Screening

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C1710032
Subject initials
Beskrivning

Subject initials

Datatyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Subject number
Beskrivning

Subject number

Alias
UMLS CUI-1
C2348585
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beskrivning

Date of visit/assessment

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

Date of visit/assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Demography
Beskrivning

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Female : Record child-bearing potential

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beskrivning

Ethnicity

Datatyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Beskrivning

Check all that apply.

Datatyp

integer

Alias
UMLS CUI [1]
C3841890
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Alias
UMLS CUI [1]
C1264639
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beskrivning

Body mass index

Datatyp

integer

Alias
UMLS CUI [1]
C1305855
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beskrivning

Subject position

Datatyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Tillbaka till toppen

Similar models

Screen - Demography; Vital Signs

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inform Screening
C1552002 (UMLS CUI-1)
C1710032 (UMLS CUI-2)
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Subject number
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry
integer
C3841890 (UMLS CUI [1])
Geographic ancestry
Code List
Geographic ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Island er (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Semi-supine (1)
CL Item
Sitting (2)
Tillbaka till toppen 

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