ID

32953

Description

This form contains a form to document the subject identification, the date of visit and the demography of the subject. To be assessed at screening. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (2)
  1. 11/17/18 11/17/18 -
  2. 11/21/18 11/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

English

Subject Identification, Date of Visit (Screening), Demography

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
If female: Record child-bearing potential
Description

Child-bearing potential

Data type

text

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3831118
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
African American/African Heritage
Description

Geographic ancestry: African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

Geographic ancestry: American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Geographic ancestry: Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Geographic ancestry: Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian -Japanese Heritage
Description

Geographic ancestry: Asian -Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Geographic ancestry : Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Geographic ancestry: Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

Geographic ancestry: White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C1552588
White - White/Caucasian/European Heritage
Description

Geographic ancestry: White - White/Caucasian/European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Subject Identification, Date of Visit (Screening), Demography

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
If female: Record child-bearing potential
text
C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
If female: Child-bearing potential
Code List
If female: Record child-bearing potential
CL Item
Pre-menarcheal (Pre-menarcheal)
CL Item
Post-menopausal (Post-menopausal)
CL Item
Sterile (of child-bearing age) (Sterile (of child-bearing age))
CL Item
Potentially able to bear children (Potentially able to bear children)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
Not Hispanic or Latino (Not Hispanic or Latino)
Geographic ancestry: African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Geographic ancestry: American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Geographic ancestry: Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Geographic ancestry: Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Geographic ancestry: Asian -Japanese Heritage
Item
Asian -Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Geographic ancestry : Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Geographic ancestry: Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Geographic ancestry: White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C1552588 (UMLS CUI [2])
Geographic ancestry: White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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