ID

26519

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.10.17 18.10.17 -
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GSK

Hochgeladen am

18. Oktober 2017

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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Englisch

Screening; Significant medical/surgical history and physical examination

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Significant medical/surgical history and physical examination
Beschreibung

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.
Beschreibung

Medical History

Datentyp

boolean

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

Significant medical/surgical history and physical examination

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

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
GSK Use
Beschreibung

GSK Use

Datentyp

text

Year of first diagnosis
Beschreibung

Year of first diagnosis

Datentyp

partialDate

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

Past disease

Datentyp

boolean

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

Ongoing Disease

Datentyp

boolean

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

GSK Use

Datentyp

text

Semi-Supine Vital Signs
Beschreibung

Semi-Supine Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Beschreibung

Study Time

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschreibung

Time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Standing BP (mmHg) Systolic
Beschreibung

Systolic Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Standing BP (mmHg) Diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
12-Lead ECG Monitoring
Beschreibung

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Beschreibung

Study Time

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beschreibung

Time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Heart Rate (bpm)
Beschreibung

Heart Rate

Datentyp

text

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschreibung

PR

Datentyp

text

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS
Beschreibung

QRS

Datentyp

text

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Beschreibung

QT

Datentyp

text

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beschreibung

QTc

Datentyp

text

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal
Beschreibung

ECG normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Beschreibung

Comments

Datentyp

text

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

12-Lead Continous Electrocardiographic Monitoring

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

Start Date

Datentyp

date

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

Start time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C4055630
24hr:min
Monitoring Stop Date
Beschreibung

Stop Date

Datentyp

date

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

Stop Time

Datentyp

time

Maßeinheiten
  • 24hr:min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C4055630
24hr:min
Rhythms of Concern
Beschreibung

Rhythms of Concern

Datentyp

boolean

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

Rhythm of Concern Description

Datentyp

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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Ähnliche Modelle

Screening; Significant medical/surgical history and physical examination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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