ID

26664

Descripción

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Palabras clave

Versiones (1)
  1. 23/10/17 23/10/17 -
Titular de derechos de autor

GSK

Subido en

23 de octubre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Inglés

Concomitant Medication

1 formularios  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Documentation
Descripción

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Descripción

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study? If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.
Descripción

Concomitant Medication Changes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
CONCOMITANT MEDICATION
Descripción

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Drug Name (Trade Name Preferred)
Descripción

Drug Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/Unit
Descripción

Drug Dosage

Tipo de datos

text

Alias
UMLS CUI [1]
C0870450
Frequency of this Dose (e.g. BID, PRN)
Descripción

Frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C3476109
Route
Descripción

Administration Route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Indication
Descripción

Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C3146298
Start Date / Time
Descripción

Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C2347852
End Date /Time
Descripción

End Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C2347852
Continuing at end of Study?
Descripción

Continuing at end of Study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1553904
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Similar models

Concomitant Medication

1 formularios
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
C2347852 (UMLS CUI-1)
Concomitant Medication Changes
Item
Are there any concomitant medication CHANGES since the start of the study? If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Drug Dosage
Item
SINGLE Dose/Unit
text
C0870450 (UMLS CUI [1])
Frequency
Item
Frequency of this Dose (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date and Time
Item
Start Date / Time
datetime
C3897500 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
End Date and Time
Item
End Date /Time
datetime
C3899266 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Continuing at end of Study
Item
Continuing at end of Study?
boolean
C1553904 (UMLS CUI [1])
Volver a la parte superior de la página 

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