ID

26521

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; Responsiveness to 7% CO2

1 Formulieren  
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Responsiveness to 7% CO2
Beschrijving

Responsiveness to 7% CO2

Alias
UMLS CUI-1
C1378652
UMLS CUI-2
C0552602
Was the subject responder to the CO2 challenge and not responder to the air-placebo challenge in a previous occasion within 12 months?
Beschrijving

Co2 Challenge Response

Datatype

boolean

Alias
UMLS CUI [1,1]
C1378652
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C0871261
UMLS CUI [1,4]
C1446409
UMLS CUI [2,1]
C0001861
UMLS CUI [2,2]
C1696465
UMLS CUI [2,3]
C0805586
UMLS CUI [2,4]
C0871261
UMLS CUI [2,5]
C0205160
CO2/Placebo
Beschrijving

CO2/Placebo

Alias
UMLS CUI-1
C0007012
UMLS CUI-3
C0032042
Exact start date and start time of Challenge 1
Beschrijving

Date | Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0805586
UMLS CUI [1,4]
C0205447
Challenge Type
Beschrijving

Challenge Type

Datatype

text

Alias
UMLS CUI [1,1]
C3166406
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C0205447
Exact start time of Challenge 2
Beschrijving

Time

Datatype

time

Maateenheden
  • 24hr:min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C0205448
24hr:min
Challenge Type
Beschrijving

Challenge Type

Datatype

text

Alias
UMLS CUI [1,1]
C3166406
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C0205448
PSL Ill-R/VAS-A
Beschrijving

PSL Ill-R/VAS-A

Alias
UMLS CUI-1
C2945698
UMLS CUI-2
C0745732
UMLS CUI-4
C3536884
UMLS CUI-5
C0003467
Challenge Type
Beschrijving

Challenge Type

Datatype

text

Alias
UMLS CUI [1]
C3166406
Questionnaire Type
Beschrijving

Questionnaire Type

Datatype

text

Alias
UMLS CUI [1,1]
C2826974
UMLS CUI [1,2]
C0332307
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

text

Alias
UMLS CUI [1]
C0439564
Date
Beschrijving

Date

Datatype

datetime

Alias
UMLS CUI [1]
C0011008
Questionnaire administered
Beschrijving

Questionnaire Administered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1521801
Comments
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Screening; Responsiveness to 7% CO2

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
Responsiveness to 7% CO2
C1378652 (UMLS CUI-1)
C0552602 (UMLS CUI-2)
Co2 Challenge Response
Item
Was the subject responder to the CO2 challenge and not responder to the air-placebo challenge in a previous occasion within 12 months?
boolean
C1378652 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C0871261 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
C0001861 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
C0805586 (UMLS CUI [2,3])
C0871261 (UMLS CUI [2,4])
C0205160 (UMLS CUI [2,5])
Item Group
C0007012 (UMLS CUI-1)
C0032042 (UMLS CUI-3)
Date | Time
Item
Exact start date and start time of Challenge 1
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0805586 (UMLS CUI [1,3])
C0205447 (UMLS CUI [1,4])
Item
text
C3166406 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C0205447 (UMLS CUI [1,3])
Challenge Type
Code List
Challenge Type
CL Item
CO2 Inhalation (CO2 Inhalation)
CL Item
AIr-placebo Inhalation (AIr-placebo Inhalation)
Time
Item
Exact start time of Challenge 2
time
C0040223 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C0205448 (UMLS CUI [1,3])
Item
text
C3166406 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C0205448 (UMLS CUI [1,3])
Challenge Type
Code List
Challenge Type
CL Item
CO2 inhalation (CO2 inhalation)
CL Item
Air-placebo inhalation (Air-placebo inhalation)
Item Group
PSL Ill-R/VAS-A
C2945698 (UMLS CUI-1)
C0745732 (UMLS CUI-2)
C3536884 (UMLS CUI-4)
C0003467 (UMLS CUI-5)
Item
Challenge Type
text
C3166406 (UMLS CUI [1])
Challenge Type
Code List
Challenge Type
CL Item
CO2 (CO2)
CL Item
Air-placebo (Air-placebo)
Item
Questionnaire Type
text
C2826974 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Questionnaire Type
Code List
Questionnaire Type
CL Item
PSL III R (PSL III R)
CL Item
VAS-A (VAS-A)
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-challenge (Pre-challenge)
CL Item
+10 min (+10 min)
CL Item
Post-challenge (Post-challenge)
Date
Item
Date
datetime
C0011008 (UMLS CUI [1])
Questionnaire Administered
Item
Questionnaire administered
boolean
C0034394 (UMLS CUI [1,1])
C1521801 (UMLS CUI [1,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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