ID

24531

Beschreibung

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

Stichworte

Versionen (1)
  1. 05.08.17 05.08.17 -
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GlaxoSmithKline

Hochgeladen am

5. August 2017

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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

Englisch

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 Formulare  
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Date
Beschreibung

physical examination date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Time
Beschreibung

physical examination time

Datentyp

time

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

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

Datentyp

boolean

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

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

Datentyp

text

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

Serum b-HCG Pregnancy Test (Females Only)

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

pregnancy test

Datentyp

boolean

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

pregnancy test reason

Datentyp

text

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

pregnancy test date and time

Datentyp

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:
Beschreibung

If POSITIVE, withdraw the subject from the study.

Datentyp

text

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

Ensure result is included on laboratory report

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Vital Signs
Beschreibung

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

vital signs date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Actual Time
Beschreibung

vital signs time

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Systolic BP
Beschreibung

systolic blood pressure

Datentyp

integer

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

diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Beschreibung

respiratory rate

Datentyp

text

Alias
UMLS CUI [1]
C0231832
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

ecg date

Datentyp

date

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

ecg time

Datentyp

time

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

heart rate

Datentyp

integer

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

pr duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Beschreibung

qrs duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Beschreibung

qt duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Beschreibung

qtc interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG Normal?
Beschreibung

ecg normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Beschreibung

ecg comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

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