ID

32885

Descripción

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

Palabras clave

Versiones (2)
  1. 18/11/18 18/11/18 -
  2. 25/11/18 25/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

Inglés

Vital Signs

1 formularios  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Descripción

Visit Type

Tipo de datos

text

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

Dosing Date and Time

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

Dosing date/time

Tipo de datos

datetime

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Timepoint
Descripción

Timepoint

Tipo de datos

text

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

Actual date/time

Tipo de datos

datetime

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

Blood pressure (systolic)

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (diastolic)
Descripción

Blood pressure (diastolic)

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

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

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Volver a la parte superior de la página

Similar models

Vital Signs

1 formularios
  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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