ID

32957

Description

This form contains a form to document the results of the electronically transferred lab data. To be assessed at screening, follow-up and where required early withdrawal visit. 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. 11/18/18 11/18/18 -
  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

Electronically Transferred Lab Data

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
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1]
C3641100
Lab
Description

Lab

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Description

If sample taken, specify date in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1264639
Haematology Date and time sample taken Hr:Min (00:00-23:59)
Description

Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1264639
Clinical Chemistry Date and time sample taken
Description

If sample taken on a different day than the Haematology sample, specify date in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry Date and time sample taken Hr:Min (00:00-23:59)
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Date and time sample taken
Description

If sample taken, specify date in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Date and time sample taken Hr:Min (00:00-23:59)
Description

Urinalysis Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
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Similar models

Electronically Transferred Lab Data

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])
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
screening (screening)
CL Item
follow-up (follow-up)
CL Item
early withdrawal (early withdrawal)
CL Item
logs/repeat (logs/repeat)
Item Group
Lab
C0022885 (UMLS CUI-1)
Item
Haematology Date and time sample taken
text
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Haematology sample taken
Code List
Haematology Date and time sample taken
CL Item
Not Done (Not Done)
CL Item
Date (Date)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken Hr:Min (00:00-23:59)
datetime
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Clinical Chemistry Date and time sample taken
Code List
Clinical Chemistry Date and time sample taken
CL Item
Same as the Haematology sample (Same as the Haematology sample)
CL Item
Not Done (Not Done)
CL Item
Date  (Date)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken Hr:Min (00:00-23:59)
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis Date and time sample taken
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Urinalysis Date and time sample taken
Code List
Urinalysis Date and time sample taken
CL Item
Not Done (Not Done)
CL Item
Date  (Date)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken Hr:Min (00:00-23:59)
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
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