ID

26545

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

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  1. 2017-10-18 2017-10-18 -
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engelsk

Session 2 Day 1

1 Formulär  
  1. StudyEvent: ODM
    1. Session 2 Day 1
Dosing Details
Beskrivning

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of GW597599/Placebo dosing
Beskrivning

Date | Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C2987637
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Beskrivning

Drug Administered Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beskrivning

Dose Witness

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Date and time of Alprazolam/Placebo dosing
Beskrivning

Date | Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C0002333
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Beskrivning

Drug Administer Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beskrivning

Dose Witness

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Start Date and time of Paroxetine/Placebo dosing
Beskrivning

Date | Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C0070122
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Beskrivning

Drug Administer Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beskrivning

Dose Witness

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.
Beskrivning

PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.

Alias
UMLS CUI-1
C0201734
Time relative to start of dose
Beskrivning

Time to dose start

Datatyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C3174092
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beskrivning

Time

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Sample Taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C1277698
Comments
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Neurosteroid Sampling
Beskrivning

Neurosteroid Sampling

Alias
UMLS CUI-1
C0815278
UMLS CUI-2
C0870078
Time relative to start of dose
Beskrivning

Time to dose start

Datatyp

text

Alias
UMLS CUI [1]
C0946444
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Sample Taken
Beskrivning

Sample Taken

Datatyp

boolean

Alias
UMLS CUI [1]
C1277698
Comments
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
5-Lead continous electrocardiographic monitoring
Beskrivning

5-Lead continous electrocardiographic monitoring

Alias
UMLS CUI-1
C3840770
UMLS CUI-2
C0420200
Monitoring Start Date
Beskrivning

Monitoring Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0808070
Monitoring Start Time
Beskrivning

Monitoring Start Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1301880
Monitoring Stop Date
Beskrivning

Monitoring Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0806020
Monitoring Stop Time
Beskrivning

Monitoring End Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1522314
Rhythms of Concern
Beskrivning

Rhythms of Concern

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
UMLS CUI [1,3]
C2699424
Describe Rhythm
Beskrivning

Rhythm Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
UMLS CUI [1,3]
C2699424
UMLS CUI [1,4]
C0678257
CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING
Beskrivning

CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING

Alias
UMLS CUI-1
C0199438
UMLS CUI-3
C3845192
UMLS CUI-5
C0150350
Time relative to start of dose
Beskrivning

Time to last dose

Datatyp

time

Måttenheter
  • hrs
Alias
UMLS CUI [1]
C0946444
hrs
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Start time
Beskrivning

Start time

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
Stop Time
Beskrivning

Stop Time

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Respiratory Parameters Monitored
Beskrivning

Respiratory Parameters Monitored

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199438
UMLS CUI [1,2]
C0521346
UMLS CUI [1,3]
C0042295
Cardiac Parameters Monitored
Beskrivning

Cardiac Parameters Monitored

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0204899
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0042295
Skin Conductance Monitored
Beskrivning

Skin Conductance Monitored

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0814024
UMLS CUI [1,2]
C1283169
7% CO2 Challenge
Beskrivning

7% CO2 Challenge

Alias
UMLS CUI-1
C1378652
UMLS CUI-2
C0805586
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Start time
Beskrivning

Start time

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
Stop Time
Beskrivning

Stop Time

Datatyp

time

Måttenheter
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Treatment Assessment for Cohort 1
Beskrivning

Treatment Assessment for Cohort 1

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0220825
UMLS CUI-3
C0599755
UMLS CUI-4
C0205447
In your opinion, which drug did you receive before the CO2 challenge?
Beskrivning

Drug received

Datatyp

text

Alias
UMLS CUI [1,1]
C0871010
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1514756
Treatment Assessment for Cohort 2
Beskrivning

Treatment Assessment for Cohort 2

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0220825
UMLS CUI-3
C0599755
UMLS CUI-4
C0205447
In your opinion, which drug did you receive before the CO2 challenge?
Beskrivning

Drug received

Datatyp

text

Alias
UMLS CUI [1,1]
C0871010
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1514756
PSL III-R/VAS-A
Beskrivning

PSL III-R/VAS-A

Alias
UMLS CUI-1
C2945698
UMLS CUI-2
C0745732
UMLS CUI-4
C3536884
UMLS CUI-5
C0003467
Questionnaire Type
Beskrivning

Questionnaire Type

Datatyp

text

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

Planned Relative Time

Datatyp

text

Alias
UMLS CUI [1]
C0439564
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Time
Beskrivning

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Questionnaire administered
Beskrivning

Questionnaire administered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0449851
UMLS CUI [1,4]
C1521801
UMLS CUI [1,5]
C0332307
Comments
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Session 2 Day 1

1 Formulär
  1. StudyEvent: ODM
    1. Session 2 Day 1
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Date | Time
Item
Date and time of GW597599/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C2987637 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administered Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Date | Time
Item
Date and time of Alprazolam/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C0002333 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administer Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Date | Time
Item
Start Date and time of Paroxetine/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C0070122 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administer Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.
C0201734 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0005834 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Time to dose start
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+45 min (+45 min)
CL Item
+1 hr (+1 hr)
CL Item
+1.35 hrs (+1.35 hrs)
CL Item
+2.30 hrs (+2.30 hrs)
CL Item
+3.30 hrs (+3.30 hrs)
CL Item
+6.30 hrs (+6.30 hrs)
CL Item
+9.30 hrs (+9.30 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24.30 hrs (+24.30 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Neurosteroid Sampling
C0815278 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
Time to dose start
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1.35 hrs (+1.35 hrs)
CL Item
+2.20 hrs (+2.20 hrs)
CL Item
+2.30 hrs (+2.30 hrs)
CL Item
+2.50 hrs (+2.50 hrs)
CL Item
+3.30 hrs (+3.30 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
5-Lead continous electrocardiographic monitoring
C3840770 (UMLS CUI-1)
C0420200 (UMLS CUI-2)
Monitoring Start Date
Item
Monitoring Start Date
date
C0420200 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Monitoring Start Time
Item
Monitoring Start Time
time
C0420200 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Monitoring Stop Date
Item
Monitoring Stop Date
date
C0420200 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Monitoring End Time
Item
Monitoring Stop Time
time
C0420200 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Rhythms of Concern
Item
Rhythms of Concern
boolean
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
C2699424 (UMLS CUI [1,3])
Rhythm Description
Item
Describe Rhythm
text
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
C2699424 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Item Group
CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING
C0199438 (UMLS CUI-1)
C3845192 (UMLS CUI-3)
C0150350 (UMLS CUI-5)
Time to last dose
Item
Time relative to start of dose
time
C0946444 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Respiratory Parameters Monitored
Item
Respiratory Parameters Monitored
boolean
C0199438 (UMLS CUI [1,1])
C0521346 (UMLS CUI [1,2])
C0042295 (UMLS CUI [1,3])
Cardiac Parameters Monitored
Item
Cardiac Parameters Monitored
boolean
C0204899 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0042295 (UMLS CUI [1,3])
Skin Conductance Monitored
Item
Skin Conductance Monitored
boolean
C0814024 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
Item Group
C1378652 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Item Group
Treatment Assessment for Cohort 1
C0087111 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0599755 (UMLS CUI-3)
C0205447 (UMLS CUI-4)
Item
In your opinion, which drug did you receive before the CO2 challenge?
text
C0871010 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
undefined item
Code List
In your opinion, which drug did you receive before the CO2 challenge?
CL Item
Alprazolam (Alprazolam)
CL Item
GW597599 + Paroxetine (GW597599 + Paroxetine)
CL Item
Paroxetine (Paroxetine)
CL Item
Placebo (Placebo)
CL Item
I do not know (I do not know)
Item Group
Treatment Assessment for Cohort 2
C0087111 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0599755 (UMLS CUI-3)
C0205447 (UMLS CUI-4)
Item
In your opinion, which drug did you receive before the CO2 challenge?
text
C0871010 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Drug received
Code List
In your opinion, which drug did you receive before the CO2 challenge?
CL Item
Alprazolam (Alprazolam)
CL Item
GW597599 + Paroxetine (GW597599 + Paroxetine)
CL Item
GW597599 (GW597599)
CL Item
Placebo (Placebo)
CL Item
I do not know (I do not know)
Item Group
PSL III-R/VAS-A
C2945698 (UMLS CUI-1)
C0745732 (UMLS CUI-2)
C3536884 (UMLS CUI-4)
C0003467 (UMLS CUI-5)
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
+1.58 hrs (+1.58 hrs)
CL Item
+2.10 hrs (+2.10 hrs)
CL Item
+2.20 hrs (+2.20 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Questionnaire administered
Item
Questionnaire administered
boolean
C0030705 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449851 (UMLS CUI [1,3])
C1521801 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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