ID

26661

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

Follow-Up

1 formularios  
  1. StudyEvent: ODM
    1. Follow-Up
Administrative Documentation
Descripción

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
URINE PREGNANCY TEST (Females only)
Descripción

URINE PREGNANCY TEST (Females only)

Alias
UMLS CUI-1
C0430056
Was a pregnancy test carried out?
Descripción

Urine Pregnancy Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430056
If 'No', please specify reason
Descripción

Reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0430056
Date and Time of pregnancy test:
Descripción

Date Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0430057
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
Descripción

Result

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430057
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
Descripción

Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Descripción

Date | Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005834
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
Comments
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Descripción

Abnormal Findings

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2826633
UMLS CUI [2,1]
C0474523
UMLS CUI [2,2]
C2826633
Ensure a urine sample has been taken for urinalysis
Descripción

Ensure a urine sample has been taken for urinalysis

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Descripción

Date | Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0040223
Comments
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Descripción

Abnormal findings

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2826633
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Similar models

Follow-Up

1 formularios
  1. StudyEvent: ODM
    1. Follow-Up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
URINE PREGNANCY TEST (Females only)
C0430056 (UMLS CUI-1)
Urine Pregnancy Test
Item
Was a pregnancy test carried out?
boolean
C0430056 (UMLS CUI [1])
Reason
Item
If 'No', please specify reason
text
C0430056 (UMLS CUI [1])
Date Time
Item
Date and Time of pregnancy test:
datetime
C0011008 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Result
Item
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
boolean
C1274040 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Item Group
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal Findings
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0008000 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C2826633 (UMLS CUI [2,2])
Item Group
Ensure a urine sample has been taken for urinalysis
C0042014 (UMLS CUI-1)
Date | Time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal findings
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0042014 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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