ID

41044

Description

This form documents the concomitant medications taken during the study. To be filled in continously. 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 (1)
  1. 6/16/20 6/16/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 16, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

English

Concomitant Medications

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
Date of visit/assessment
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Concomintant Medications
Description

Concomintant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

Concomitant Agent Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Description

Concomitant Agent Unit Dose

Data type

float

Alias
UMLS CUI [1]
C2826646
Units
Description

Concomitant Agent Unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Frequency
Description

Concomitant Agent Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Concomitant Agent Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Description

Concomitant Agent Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start Date and Time
Description

Hr:Min (00:00-23:59)

Data type

datetime

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Taken Prior to Study?
Description

Concomitant Agent Taken Prior to Study?

Data type

text

Alias
UMLS CUI [1]
C2826667
Ongoing?
Description

Concomitant Agent Ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
End Date and Time
Description

Hr:Min (00:00-23:59) To be filled in if the angent is not ongoing.

Data type

datetime

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
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Similar models

Concomitant Medications

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
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Concomintant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent Unit Dose
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Concomitant Agent Unit
Item
Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Agent Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent Indication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Agent Start Date Time
Item
Start Date and Time
datetime
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Concomitant Agent Taken Prior to Study?
Code List
Taken Prior to Study?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant Agent Ongoing
Code List
Ongoing?
CL Item
Yes (Yes)
CL Item
No, specify End Date and Time (No, specify End Date and Time)
Concomitant Agent End Date Time
Item
End Date and Time
datetime
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
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