ID

26516

Beschrijving

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

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  1. 18-10-17 18-10-17 -
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engels

Screening Laboratory Collections

1 Formulieren  
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.
Beschrijving

Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.

Alias
UMLS CUI-1
C0014912
UMLS CUI-3
C0202022
Exact date and time of blood sampling
Beschrijving

Date and Time of Blood sampling

Datatype

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Estradiol
Beschrijving

Estradiol

Datatype

text

Alias
UMLS CUI [1]
C0014912
FSH
Beschrijving

FSH

Datatype

text

Alias
UMLS CUI [1]
C0202022
Clinical Chemistry and Haematology
Beschrijving

Clinical Chemistry and Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0474523
Exact date and time of blood sampling
Beschrijving

Date | Time

Datatype

datetime

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

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
Beschrijving

Abnormal Value

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2826633
Urinanalysis
Beschrijving

Urinanalysis

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

Date | Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
Beschrijving

Abnormal values

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C2826633
Drug Screening (Urine)
Beschrijving

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Exact date and time of sampling
Beschrijving

Date | Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below
Beschrijving

Drug Detection

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444657
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1511790
Type of Drug
Beschrijving

Type of Drug

Datatype

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.
Beschrijving

Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0019163
UMLS CUI-3
C0019196
Exact date and time of blood sampling
Beschrijving

Date | Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
URINE PREGNANCY TEST (Females only)
Beschrijving

URINE PREGNANCY TEST (Females only)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Beschrijving

Pregnancy Test

Datatype

boolean

Alias
UMLS CUI [1]
C0032976
If 'No', please specify reason
Beschrijving

Reason No

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0032976
If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
Beschrijving

Date | Time Pregnancy Test

Datatype

datetime

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
Beschrijving

Result Pregnancy Test

Datatype

text

Alias
UMLS CUI [1]
C3259477
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Similar models

Screening Laboratory Collections

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.
C0014912 (UMLS CUI-1)
C0202022 (UMLS CUI-3)
Date and Time of Blood sampling
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Estradiol
Item
Estradiol
text
C0014912 (UMLS CUI [1])
FSH
Item
FSH
text
C0202022 (UMLS CUI [1])
Item Group
C0008000 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal Value
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
boolean
C0205161 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Item Group
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])
C0040223 (UMLS CUI [1,3])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal values
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
boolean
C0205161 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
Item Group
C0202274 (UMLS CUI-1)
Date | Time
Item
Exact date and time of sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Drug Detection
Item
Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below
boolean
C1444657 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
Type of Drug
Item
Type of Drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.
C0019682 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
URINE PREGNANCY TEST (Females only)
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
Reason No
Item
If 'No', please specify reason
text
C0392360 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Date | Time Pregnancy Test
Item
If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
datetime
C0430060 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
text
C3259477 (UMLS CUI [1])
Result Pregnancy Test
Code List
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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