ID

37585

Beschreibung

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

Stichworte

Versionen (1)
  1. 08.08.19 08.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. August 2019

DOI

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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

Englisch

Screen - Eligibility Question

1 Formulare  
Date of visit/assessment
Beschreibung

Date of visit/assessment

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

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Did the subject meet all the entry criteria?

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Select all boxes corresponding to violations of any inclusion criteria.
Beschreibung

Select all boxes corresponding to violations of any inclusion criteria

Datentyp

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1709750
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Select all boxes corresponding to violations of any exclusion criteria.
Beschreibung

Select all boxes corresponding to violations of any exclusion criteria.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1709750
Inclusion Criteria ADOLESCENTS ONLY
Beschreibung

Inclusion Criteria ADOLESCENTS ONLY

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0205653
Select all boxes corresponding to violations of any inclusion criteria.
Beschreibung

Select all boxes corresponding to violations of any inclusion criteria.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1709750
Exclusion Criteria ADOLESCENTS ONLY
Beschreibung

Exclusion Criteria ADOLESCENTS ONLY

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0205653
Select all boxes corresponding to violations of any exclusion criteria.
Beschreibung

Select all boxes corresponding to violations of any exclusion criteria.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1709750
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Ähnliche Modelle

Screen - Eligibility Question

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Item
Select all boxes corresponding to violations of any inclusion criteria.
integer
C1512693 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Select all boxes corresponding to violations of any inclusion criteria
Code List
Select all boxes corresponding to violations of any inclusion criteria.
CL Item
Inclusion Criteria 1  (1)
CL Item
Inclusion Criteria 2  (2)
CL Item
Inclusion Criteria 3  (3)
CL Item
Inclusion Criteria 4  (4)
CL Item
Inclusion Criteria 5  (5)
CL Item
Inclusion Criteria 6 (6)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Item
Select all boxes corresponding to violations of any exclusion criteria.
integer
C0680251 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Select all boxes corresponding to violations of any exclusion criteria.
Code List
Select all boxes corresponding to violations of any exclusion criteria.
CL Item
Exclusion Criteria 1 (1)
CL Item
Exclusion Criteria 2 (2)
CL Item
Exclusion Criteria 3 (3)
CL Item
Exclusion Criteria 4 (4)
CL Item
Exclusion Criteria 5 (5)
CL Item
Exclusion Criteria 6 (6)
CL Item
Exclusion Criteria 7 (7)
CL Item
Exclusion Criteria 8 (8)
CL Item
Exclusion Criteria 9 (9)
CL Item
Exclusion Criteria 10 (10)
CL Item
Exclusion Criteria 11 (11)
CL Item
Exclusion Criteria 12 (12)
CL Item
Exclusion Criteria 13 (13)
CL Item
Exclusion Criteria 14 (14)
CL Item
Exclusion Criteria 15 (15)
CL Item
Exclusion Criteria 16 (16)
CL Item
Exclusion Criteria 17 (17)
CL Item
Exclusion Criteria 18 (18)
CL Item
Exclusion Criteria 19 (19)
CL Item
Exclusion Criteria 20 (20)
CL Item
Exclusion Criteria 21 (21)
CL Item
Exclusion Criteria 22 (22)
CL Item
Exclusion Criteria 23 (23)
CL Item
Exclusion Criteria 24 (24)
CL Item
Exclusion Criteria 25 (25)
CL Item
Exclusion Criteria 26 (26)
CL Item
Exclusion Criteria 27 (27)
Item Group
Inclusion Criteria ADOLESCENTS ONLY
C1512693 (UMLS CUI-1)
C0205653 (UMLS CUI-2)
Item
Select all boxes corresponding to violations of any inclusion criteria.
integer
C1512693 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Select all boxes corresponding to violations of any inclusion criteria.
Code List
Select all boxes corresponding to violations of any inclusion criteria.
CL Item
Inclusion Criteria 1 Adolescent (1)
CL Item
lnclusion Criteria 2 Adolescent (2)
CL Item
Inclusion Criteria 3 Adolescent (3)
CL Item
lnclusion Criteria 4 Adolescent (4)
CL Item
Inclusion Criteria 5 Adolescent (5)
Item Group
Exclusion Criteria ADOLESCENTS ONLY
C0680251 (UMLS CUI-1)
C0205653 (UMLS CUI-2)
Item
Select all boxes corresponding to violations of any exclusion criteria.
integer
C0680251 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Select all boxes corresponding to violations of any exclusion criteria.
Code List
Select all boxes corresponding to violations of any exclusion criteria.
CL Item
Exclusion Criteria 1 Adolescent (1)
CL Item
Exclusion Criteria 2 Adolescent (2)
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