ID

26516

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-10-18 2017-10-18 -
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18 oktober 2017

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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engelsk

Screening Laboratory Collections

1 Formulär  
Administrative Documentation
Beskrivning

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

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.
Beskrivning

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
Beskrivning

Date and Time of Blood sampling

Datatyp

datetime

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

Estradiol

Datatyp

text

Alias
UMLS CUI [1]
C0014912
FSH
Beskrivning

FSH

Datatyp

text

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

Clinical Chemistry and Haematology

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

Date | Time

Datatyp

datetime

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

Comment

Datatyp

text

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

Abnormal Value

Datatyp

boolean

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

Urinanalysis

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

Date | Time

Datatyp

datetime

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

Comment

Datatyp

text

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

Abnormal values

Datatyp

boolean

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

Drug Screening (Urine)

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

Date | Time

Datatyp

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
Beskrivning

Drug Detection

Datatyp

boolean

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

Type of Drug

Datatyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beskrivning

Comment

Datatyp

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.
Beskrivning

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
Beskrivning

Date | Time

Datatyp

datetime

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

Comment

Datatyp

text

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

URINE PREGNANCY TEST (Females only)

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

Pregnancy Test

Datatyp

boolean

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

Reason No

Datatyp

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:
Beskrivning

Date | Time Pregnancy Test

Datatyp

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.
Beskrivning

Result Pregnancy Test

Datatyp

text

Alias
UMLS CUI [1]
C3259477
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Similar models

Screening Laboratory Collections

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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