ID

26660

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

Versions (1)
  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

English

Treatment Phase

1 forms  
  1. StudyEvent: ODM
    1. Treatment Phase
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Pharmacogenetic Research
Description

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for Pharmacogenetic Research?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0031325
If Yes, record the date informed consent obtained for pharmacogenetic
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0031325
If No, check one reason:
Description

Denial Reason

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C1705116
UMLS CUI [1,4]
C3274861
Has a blood sample been collected for Pharmacogenetic Research?
Description

Blood Sample Collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
If YES, record the date the sample was taken:
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0031325
Has this subject withdrawn consent for Pharmacogenetic Research?
Description

Withdrawal of Consent

Data type

boolean

Alias
UMLS CUI [1]
C1707492
Has a request been made for sample destruction?
Description

Blood sample destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason
Description

Blood sample destruction reason

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
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Similar models

Treatment Phase

1 forms
  1. StudyEvent: ODM
    1. Treatment Phase
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
Informed Consent
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Date
Item
If Yes, record the date informed consent obtained for pharmacogenetic
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Item
If No, check one reason:
text
C0021430 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
C3274861 (UMLS CUI [1,4])
Denial Reason
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (3)
Blood Sample Collection
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Date
Item
If YES, record the date the sample was taken:
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Withdrawal of Consent
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C1707492 (UMLS CUI [1])
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Blood sample destruction reason
Code List
If Yes, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
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