ID

24531

Descripción

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Physical Examination, b-HCG Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

Palabras clave

Versiones (1)
  1. 5/8/17 5/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

Inglés

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

1 formularios  
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Date
Descripción

physical examination date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Time
Descripción

physical examination time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826761
Has there been any change from the last examination (Screening)?
Descripción

Record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Has there been any change from the last examination (Screening)?
Descripción

Record below. Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
Serum b-HCG Pregnancy Test (Females Only)
Descripción

Serum b-HCG Pregnancy Test (Females Only)

Alias
UMLS CUI-1
C0430060
Was a pregnancy test carried out?
Descripción

pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430060
If NO, please specify reason
Descripción

pregnancy test reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0430060
If YES, please indicate date and time of test and result: Date and time of pregnancy test
Descripción

pregnancy test date and time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
If YES, please indicate date and time of test and result:
Descripción

If POSITIVE, withdraw the subject from the study.

Tipo de datos

text

Alias
UMLS CUI [1]
C0032976
Laboratory name, if applicable
Descripción

Ensure result is included on laboratory report

Tipo de datos

text

Alias
UMLS CUI [1]
C1882331
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Descripción

study time

Tipo de datos

text

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

vital signs date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826644
Actual Time
Descripción

vital signs time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic BP
Descripción

systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Descripción

diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Descripción

respiratory rate

Tipo de datos

text

Alias
UMLS CUI [1]
C0231832
12-Lead ECG Monitoring
Descripción

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Descripción

study time

Tipo de datos

text

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

ecg date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Actual Time
Descripción

ecg time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart Rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Descripción

pr duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Descripción

qrs duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Descripción

qt duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Descripción

qtc interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG Normal?
Descripción

ecg normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Descripción

ecg comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
physical examination date
Item
Date
date
C2826643 (UMLS CUI [1])
physical examination time
Item
Time
time
C2826761 (UMLS CUI [1])
physical examination change
Item
Has there been any change from the last examination (Screening)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
physical examination change
Item
Has there been any change from the last examination (Screening)?
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Serum b-HCG Pregnancy Test (Females Only)
C0430060 (UMLS CUI-1)
pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0430060 (UMLS CUI [1])
pregnancy test reason
Item
If NO, please specify reason
text
C0430060 (UMLS CUI [1])
pregnancy test date and time
Item
If YES, please indicate date and time of test and result: Date and time of pregnancy test
datetime
C0430060 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
If YES, please indicate date and time of test and result:
text
C0032976 (UMLS CUI [1])
pregnancy test result
Code List
If YES, please indicate date and time of test and result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
laboratory name
Item
Laboratory name, if applicable
text
C1882331 (UMLS CUI [1])
Item Group
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
Follow-up (Follow-up)
CL Item
Unscheduled (Unscheduled)
vital signs date
Item
Date
date
C2826644 (UMLS CUI [1])
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
systolic blood pressure
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
heart rate
Item
HR
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
Respiratory Rate
text
C0231832 (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
Follow-up (Follow-up)
CL Item
Unscheduled (Unscheduled)
ecg date
Item
Date
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ecg time
Item
Actual Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
pr duration
Item
PR
float
C1880446 (UMLS CUI [1])
qrs duration
Item
QRS
float
C0429025 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc interval
Item
QTC
float
C0855331 (UMLS CUI [1])
ecg normal
Item
ECG Normal?
boolean
C0522054 (UMLS CUI [1])
ecg comment
Item
Comments
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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