ID

26525

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. 10/18/17 10/18/17 -
Copyright Holder

GSK

Uploaded on

October 18, 2017

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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

Investigator Use Part

1 forms  
  1. StudyEvent: ODM
    1. Investigator Use Part
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of Comment
Description

Date

Data type

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947611
CRF page number if applicable
Description

Page Number

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C1515022
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator's Statement
Description

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Investigator´s Checklist (tick when done)
Description

Checklist

Data type

text

Alias
UMLS CUI [1]
C1707357
I certify that the observations and findings are recorded correctly and completely in this CRF.
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Investigator Use Part

1 forms
  1. StudyEvent: ODM
    1. Investigator Use Part
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date
Item
Date of Comment
text
C0011008 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Page Number
Item
CRF page number if applicable
integer
C0237753 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1515022 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Item
Investigator´s Checklist (tick when done)
text
C1707357 (UMLS CUI [1])
Checklist
Code List
Investigator´s Checklist (tick when done)
CL Item
Check all Adverse Event forms are up to date and complete (Check all Adverse Event forms are up to date and complete)
CL Item
Check that the Concomitant Medication form is up to date (Check that the Concomitant Medication form is up to date)
CL Item
Check that all appropriate pages are signed (thus indicating completion) and dated (Check that all appropriate pages are signed (thus indicating completion) and dated)
CL Item
Check that laboratory results are included (Check that laboratory results are included)
Investigator Signature
Item
I certify that the observations and findings are recorded correctly and completely in this CRF.
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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