ID

37582

Description

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

Keywords

Versions (2)
  1. 8/6/19 8/6/19 -
  2. 8/8/19 8/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 8, 2019

DOI

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License

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

English

Dose - Pharmacokinetics Blood (Naproxen); Pharmacokinetics Blood (Sumatriptan)

1 forms  
Date of visit/assessment
Description

Date of visit/assessment

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

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Pharmacokinetics Blood (Naproxen) - Dosing Date and Time
Description

Pharmacokinetics Blood (Naproxen) - Dosing Date and Time

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0027396
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood (Naproxen) - Dosing Date / Time
Description

Pharmacokinetics Blood (Naproxen) - Dosing Date / Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0027396
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0040223
Pharmacokinetics Blood (Naproxen)
Description

Pharmacokinetics Blood (Naproxen)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0027396
Pharmacokinetics Blood (Naproxen) - Timepoint
Description

Pharmacokinetics Blood (Naproxen) - Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0027396
UMLS CUI [2]
C2348792
Pharmacokinetics Blood (Naproxen) - Actual time
Description

Pre-Dose - 8 HR

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0027396
UMLS CUI [2]
C0040223
Pharmacokinetics Blood (Naproxen) - Actual date/ time
Description

10 HR - 48 HR

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0027396
UMLS CUI [2]
C1264639
Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time
Description

Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0075632
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time
Description

Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0075632
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0040223
Pharmacokinetics Blood (Sumatriptan)
Description

Pharmacokinetics Blood (Sumatriptan)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0075632
Pharmacokinetics Blood (Sumatriptan) - Timepoint
Description

Pharmacokinetics Blood (Sumatriptan) - Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0075632
UMLS CUI [2]
C2348792
Pharmacokinetics Blood (Sumatriptan) - Actual time
Description

Pre-Dose - 8 HR

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0075632
UMLS CUI [2]
C0040223
Pharmacokinetics Blood (Sumatriptan) - Actual date/ time
Description

10 HR - 48 HR

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0075632
UMLS CUI [2]
C1264639
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Similar models

Dose - Pharmacokinetics Blood (Naproxen); Pharmacokinetics Blood (Sumatriptan)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood (Naproxen) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0027396 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood (Naproxen) - Dosing Date / Time
Item
Pharmacokinetics Blood (Naproxen) - Dosing Date / Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0040223 (UMLS CUI [1,6])
Item Group
Pharmacokinetics Blood (Naproxen)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0027396 (UMLS CUI-3)
Item
Pharmacokinetics Blood (Naproxen) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Pharmacokinetics Blood (Naproxen) - Timepoint
Code List
Pharmacokinetics Blood (Naproxen) - Timepoint
CL Item
Pre-Dose (1)
CL Item
0.25 HR (2)
CL Item
0.5 HR (3)
CL Item
1 HR (4)
CL Item
1.5 HR (5)
CL Item
2 HR (6)
CL Item
3 HR (7)
CL Item
4 HR (8)
CL Item
6 HR (9)
CL Item
8 HR (10)
CL Item
10 HR (11)
CL Item
12 HR (12)
CL Item
24 HR (13)
CL Item
48 HR (14)
Pharmacokinetics Blood (Naproxen) - Actual time
Item
Pharmacokinetics Blood (Naproxen) - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
Pharmacokinetics Blood (Naproxen) - Actual date/ time
Item
Pharmacokinetics Blood (Naproxen) - Actual date/ time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0027396 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
Item Group
Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0075632 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time
Item
Pharmacokinetics Blood (Sumatriptan) - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0040223 (UMLS CUI [1,6])
Item Group
Pharmacokinetics Blood (Sumatriptan)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0075632 (UMLS CUI-3)
Item
Pharmacokinetics Blood (Sumatriptan) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Pharmacokinetics Blood (Sumatriptan) - Timepoint
Code List
Pharmacokinetics Blood (Sumatriptan) - Timepoint
CL Item
Pre-Dose  (1)
CL Item
0.25 HR  (2)
CL Item
0.5 HR  (3)
CL Item
1 HR  (4)
CL Item
1.5 HR  (5)
CL Item
2 HR  (6)
CL Item
3 HR  (7)
CL Item
4 HR  (8)
CL Item
6 HR  (9)
CL Item
8 HR (10)
CL Item
10 HR (11)
CL Item
12 HR (12)
CL Item
24 HR (13)
CL Item
48 HR (14)
Pharmacokinetics Blood (Sumatriptan) - Actual time
Item
Pharmacokinetics Blood (Sumatriptan) - Actual time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
Pharmacokinetics Blood (Sumatriptan) - Actual date/ time
Item
Pharmacokinetics Blood (Sumatriptan) - Actual date/ time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0075632 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
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