ID

33049

Description

This form contains a form to document the vital signs. To be assessed at the visits V1-V3. 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. 11/25/18 11/25/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 25, 2018

DOI

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License

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

English

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
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
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1]
C3641100
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Timepoint
Description

Timepoint

Data type

text

Alias
UMLS CUI [1]
C2348792
Actual date/time Hr:Min (00:00-23:59)
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Blood pressure (systolic)
Description

Blood pressure (systolic)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Description

Blood pressure (diastolic)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

To be assessed at the following timepoints: Pre-dose 1, 1.5 hours, 2.5 hours, 4 hours

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
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])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C3641100 (UMLS CUI [1])
Visit Type
Code List
Visit Type
CL Item
V1 (V1)
CL Item
V2 (V2)
CL Item
V3 (V3)
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Timepoint
text
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre-dose 1 (Pre-dose 1)
CL Item
Pre-dose 2 (Pre-dose 2)
CL Item
Pre-dose 3 (Pre-dose 3)
CL Item
0.25 hours (0.25 hours)
CL Item
0.5 hours (0.5 hours)
CL Item
0.75 hours (0.75 hours)
CL Item
1 hour (1 hour)
CL Item
1.25 hours (1.25 hours)
CL Item
1.5 hours (1.5 hours)
CL Item
1.75 hours (1.75 hours)
CL Item
2 hours (2 hours)
CL Item
2.25 hours (2.25 hours)
CL Item
2.5 hours (2.5 hours)
CL Item
2.75 hours (2.75 hours)
CL Item
3 hours (3 hours)
CL Item
3.25 hours (3.25 hours)
CL Item
3.5 hours (3.5 hours)
CL Item
3.75 hours (3.75 hours)
CL Item
4 hours (4 hours)
CL Item
4.25 hours (4.25 hours)
CL Item
4.5 hours (4.5 hours)
CL Item
4.75 hours (4.75 hours)
CL Item
5 hours (5 hours)
CL Item
5.25 hours (5.25 hours)
CL Item
5.5 hours (5.5 hours)
CL Item
5.75 hours (5.75 hours)
CL Item
6 hours (6 hours)
CL Item
6.25 hours (6.25 hours)
CL Item
6.5 hours (6.5 hours)
CL Item
6.75 hours (6.75 hours)
CL Item
7 hours (7 hours)
CL Item
7.25 hours (7.25 hours)
CL Item
7.5 hours (7.5 hours)
CL Item
7.75 hours (7.75 hours)
CL Item
8 hours (8 hours)
CL Item
8.5 hours (8.5 hours)
CL Item
9 hours (9 hours)
CL Item
9.5 hours (9.5 hours)
CL Item
10 hours (10 hours)
Actual date/time
Item
Actual date/time Hr:Min (00:00-23:59)
datetime
C1264639 (UMLS CUI [1])
Blood pressure (systolic)
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Blood pressure (diastolic)
Item
Blood pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
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