ID

37584

Beschrijving

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

Trefwoorden

Versies (2)
  1. 06-08-19 06-08-19 -
  2. 08-08-19 08-08-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 augustus 2019

DOI

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Licentie

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

Engels

Dose - Vital Signs (Pre-Dose - 2 HR); Vital Signs (2.5 - 8 HR)

1 Formulieren  
Date of visit/assessment
Beschrijving

Date of visit/assessment

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

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Vital Signs (Pre-dose - 2 HR) - Dosing Date and Time
Beschrijving

Vital Signs (Pre-dose - 2 HR) - Dosing Date and Time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
UMLS CUI-3
C0439227
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Vital Signs (Pre-dose - 2 HR) - Dosing date/time
Beschrijving

Vital Signs (Pre-dose - 2 HR) - Dosing date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0439227
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Vital Signs (Pre-dose - 2 HR)
Beschrijving

Vital Signs (Pre-dose - 2 HR)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
UMLS CUI-3
C0439227
Vital Signs (Pre-dose - 2 HR) - Timepoint
Beschrijving

Vital Signs (Pre-dose - 2 HR) - Timepoint

Datatype

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
UMLS CUI [3]
C2348792
Vital Signs (Pre-dose - 2 HR) - Actual Time
Beschrijving

Vital Signs (Pre-dose - 2 HR) - Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
Systolic Blood Pressure (Pre-dose - 2 HR)
Beschrijving

Systolic Blood Pressure (Pre-dose - 2 HR)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
mm[Hg]
Diastolic Blood Pressure (Pre-dose - 2 HR)
Beschrijving

Diastolic Blood Pressure (Pre-dose - 2 HR)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
mm[Hg]
Subject position (Pre-dose - 2 HR)
Beschrijving

(Position must be consistent throughout the study)

Datatype

integer

Alias
UMLS CUI [1]
C1262869
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
Vital Signs (2.5 - 8 HR) - Dosing Date and Time
Beschrijving

Vital Signs (2.5 - 8 HR) - Dosing Date and Time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439227
UMLS CUI-3
C0178602
UMLS CUI-4
C0011008
UMLS CUI-5
C0040223
Vital Signs (2.5 - 8 HR) - Dosing date/time
Beschrijving

Vital Signs (2.5 - 8 HR) - Dosing date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439227
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Vital Signs (2.5 - 8 HR)
Beschrijving

Vital Signs (2.5 - 8 HR)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439227
Vital Signs (2.5 - 8 HR) - Timepoint
Beschrijving

Vital Signs (2.5 - 8 HR) - Timepoint

Datatype

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439227
UMLS CUI [3]
C2348792
Vital Signs (2.5 HR - 8 HR) - Actual Time
Beschrijving

Vital Signs (2.5 HR - 8 HR) - Actual Time

Datatype

time

Alias
UMLS CUI [1]
C2826762
UMLS CUI [2]
C0439227
Systolic Blood Pressure (2.5 - 8 HR)
Beschrijving

Systolic Blood Pressure (2.5 - 8 HR)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0439227
mm[Hg]
Diastolic Blood Pressure (2.5 HR - 8 HR)
Beschrijving

Diastolic Blood Pressure (2.5 HR - 8 HR)

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
UMLS CUI [2]
C0439227
mm[Hg]
Subject position (2.5 HR - 8 HR)
Beschrijving

(Position must be consistent throughout the study)

Datatype

integer

Alias
UMLS CUI [1]
C1262869
UMLS CUI [2,1]
C0439565
UMLS CUI [2,2]
C0439227
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Similar models

Dose - Vital Signs (Pre-Dose - 2 HR); Vital Signs (2.5 - 8 HR)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
Vital Signs (Pre-dose - 2 HR) - Dosing Date and Time
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Vital Signs (Pre-dose - 2 HR) - Dosing date/time
Item
Vital Signs (Pre-dose - 2 HR) - Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Vital Signs (Pre-dose - 2 HR)
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439227 (UMLS CUI-3)
Item
Vital Signs (Pre-dose - 2 HR) - Timepoint
integer
C0518766 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
C2348792 (UMLS CUI [3])
Vital Signs - Timepoint
Code List
Vital Signs (Pre-dose - 2 HR) - Timepoint
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
0.25 HR (4)
CL Item
0.5 HR (5)
CL Item
0.75 HR (6)
CL Item
1 HR (7)
CL Item
1.25 HR (8)
CL Item
1.5 HR (9)
CL Item
1.75 HR (10)
CL Item
2 HR (11)
Vital Signs (Pre-dose - 2 HR) - Actual Time
Item
Vital Signs (Pre-dose - 2 HR) - Actual Time
time
C2826762 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
Systolic Blood Pressure (Pre-dose - 2 HR)
Item
Systolic Blood Pressure (Pre-dose - 2 HR)
integer
C0871470 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
Diastolic Blood Pressure (Pre-dose - 2 HR)
Item
Diastolic Blood Pressure (Pre-dose - 2 HR)
integer
C0428883 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
Item
Subject position (Pre-dose - 2 HR)
integer
C1262869 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
Subject position
Code List
Subject position (Pre-dose - 2 HR)
CL Item
Semi-supine (4)
CL Item
Sitting (2)
Item Group
Vital Signs (2.5 - 8 HR) - Dosing Date and Time
C0518766 (UMLS CUI-1)
C0439227 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
Vital Signs (2.5 - 8 HR) - Dosing date/time
Item
Vital Signs (2.5 - 8 HR) - Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Vital Signs (2.5 - 8 HR)
C0518766 (UMLS CUI-1)
C0439227 (UMLS CUI-2)
Item
Vital Signs (2.5 - 8 HR) - Timepoint
integer
C0518766 (UMLS CUI [1])
C0439227 (UMLS CUI [2])
C2348792 (UMLS CUI [3])
Vital Signs (2.5 - 8 HR) - Timepoint
Code List
Vital Signs (2.5 - 8 HR) - Timepoint
CL Item
2.5 HR  (1)
CL Item
3 HR (2)
CL Item
3.5 HR (3)
CL Item
4 HR  (4)
CL Item
4.5 HR  (5)
CL Item
5 HR (6)
CL Item
5.5 HR  (7)
CL Item
6 HR  (8)
CL Item
6.5 HR  (9)
CL Item
7 HR (10)
CL Item
7.5 HR (11)
CL Item
8 HR (12)
Vital Signs (2.5 HR - 8 HR) - Actual Time
Item
Vital Signs (2.5 HR - 8 HR) - Actual Time
time
C2826762 (UMLS CUI [1])
C0439227 (UMLS CUI [2])
Systolic Blood Pressure (2.5 - 8 HR)
Item
Systolic Blood Pressure (2.5 - 8 HR)
integer
C0871470 (UMLS CUI [1])
C0439227 (UMLS CUI [2])
Diastolic Blood Pressure (2.5 HR - 8 HR)
Item
Diastolic Blood Pressure (2.5 HR - 8 HR)
integer
C0428883 (UMLS CUI [1])
C0439227 (UMLS CUI [2])
Item
Subject position (2.5 HR - 8 HR)
integer
C1262869 (UMLS CUI [1])
C0439565 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
Subject position (2.5 HR - 8 HR)
Code List
Subject position (2.5 HR - 8 HR)
CL Item
Semi-supine  (4)
CL Item
Sitting (2)
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