ID

32885

Beskrivning

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

Länk

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

Nyckelord

  1. 2018-11-18 2018-11-18 -
  2. 2018-11-25 2018-11-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

text

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

Dosing Date and Time

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

Dosing date/time

Datatyp

datetime

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Timepoint
Beskrivning

Timepoint

Datatyp

text

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

Actual date/time

Datatyp

datetime

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

Blood pressure (systolic)

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Beskrivning

Blood pressure (diastolic)

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

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

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial