ID

37520

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 (1)
  1. 8/4/19 8/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 4, 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 - Randomisation Number; Investigational Product

1 forms  
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Was the subject able to be randomised?

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
If subject was randomised, provide Randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
If subject was randomised, provide Date of randomisation
Description

Date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date/time of dose
Description

Date/time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Investigational Product
Description

Investigational Product

Data type

integer

Alias
UMLS CUI [1]
C0304229
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1272706
If subject did not receive the correct treatment, record reason(s)
Description

If subject did not receive the correct treatment, record reason(s)

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
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Similar models

Dose - Randomisation Number; Investigational Product

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Randomisation Number
Item
If subject was randomised, provide Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
If subject was randomised, provide Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product
CL Item
10 mg Sumaptriptan/ 60 mg Naproxen Sodium (422)
CL Item
30 mg Sumaptriptan/ 180 mg Naproxen Sodium (423)
CL Item
85 mg Sumaptriptan/ soomg Naproxen Sodium (424)
Did the subject receive the correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
If subject did not receive the correct treatment, record reason(s)
Item
If subject did not receive the correct treatment, record reason(s)
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
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