ID

26519

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

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

Screening; Significant medical/surgical history and physical examination

1 forms  
Administrative Documentation
Description

Administrative Documentation

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
Significant medical/surgical history and physical examination
Description

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition? List below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Description

Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0750502
Significant medical/surgical history and physical examination
Description

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
GSK Use
Description

GSK Use

Data type

text

Year of first diagnosis
Description

Year of first diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Past
Description

Past disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
Ongoing
Description

Ongoing Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
For GSK
Description

GSK Use

Data type

text

Semi-Supine Vital Signs
Description

Semi-Supine Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Description

Study Time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Standing BP (mmHg) Systolic
Description

Systolic Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Standing BP (mmHg) Diastolic
Description

Diastolic Blood Pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
12-Lead ECG Monitoring
Description

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Description

Study Time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Heart Rate (bpm)
Description

Heart Rate

Data type

text

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

PR

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Description

QRS

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

QT

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
12-Lead Continous Electrocardiographic Monitoring
Description

12-Lead Continous Electrocardiographic Monitoring

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C4055630
Monitoring Start date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4055630
Monitoring Start Time
Description

Start time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C4055630
24hr:min
Monitoring Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C4055630
Monitoring Stop Time
Description

Stop Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C4055630
24hr:min
Rhythms of Concern
Description

Rhythms of Concern

Data type

boolean

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

Rhythm of Concern Description

Data type

text

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
UMLS CUI [1,3]
C2699424
UMLS CUI [1,4]
C0678257
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Similar models

Screening; Significant medical/surgical history and physical examination

1 forms
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Medical History
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition? List below one diagnosis per line. (Please print clearly) Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
boolean
C0262926 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
GSK Use
Item
GSK Use
text
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Past disease
Item
Past
boolean
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Ongoing Disease
Item
Ongoing
boolean
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
GSK Use
Item
For GSK
text
Item Group
Semi-Supine Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Standing BP (mmHg) Systolic
text
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Standing BP (mmHg) Diastolic
text
C0428883 (UMLS CUI [1])
Item Group
12-Lead ECG Monitoring
C0430456 (UMLS CUI-1)
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study Time
Code List
Study Time
CL Item
Screening (Screening)
CL Item
Unsched (Unsched)
CL Item
Unsched (Unsched)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Heart Rate
Item
Heart Rate (bpm)
text
C0018810 (UMLS CUI [1])
PR
Item
PR
text
C0429087 (UMLS CUI [1])
QRS
Item
QRS
text
C1880451 (UMLS CUI [1])
QT
Item
QT
text
C1287082 (UMLS CUI [1])
QTc
Item
QTc
text
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal
boolean
C0522054 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
12-Lead Continous Electrocardiographic Monitoring
C0430456 (UMLS CUI-1)
C4055630 (UMLS CUI-2)
Start Date
Item
Monitoring Start date
date
C0808070 (UMLS CUI [1,1])
C4055630 (UMLS CUI [1,2])
Start time
Item
Monitoring Start Time
time
C1301880 (UMLS CUI [1,1])
C4055630 (UMLS CUI [1,2])
Stop Date
Item
Monitoring Stop Date
date
C0806020 (UMLS CUI [1,1])
C4055630 (UMLS CUI [1,2])
Stop Time
Item
Monitoring Stop Time
time
C1522314 (UMLS CUI [1,1])
C4055630 (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 of Concern 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])
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