ID

26654

Description

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

Keywords

  1. 10/23/17 10/23/17 -
Copyright Holder

GSK

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0

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

Session 3 Day -1

  1. StudyEvent: ODM
    1. Session 3 Day -1
Default Itemgroup
Description

Default Itemgroup

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Drug Screening (Urine)
Description

Drug Screening (Urine)

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

Date | Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Were there any contra-indicated drugs detected?
Description

Contraindicated Drug detected

Data type

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C3845816
Type of drug
Description

drug type

Data type

text

Alias
UMLS CUI [1]
C0457591
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Alcohol Breath Test
Description

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Exact date and time of test
Description

Date | Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Result
Description

Result

Data type

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040

Similar models

Session 3 Day -1

  1. StudyEvent: ODM
    1. Session 3 Day -1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Default Itemgroup
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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])
Contraindicated Drug detected
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
drug type
Item
Type of drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Date | Time
Item
Exact date and time of test
datetime
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)

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