ID

24050

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: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Stichworte

Versionen (2)
  1. 24.07.17 24.07.17 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

24. Juli 2017

DOI

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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

1 Formulare  
Pharmacogenetic Research
Beschreibung

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for Pharmacogenetic Research?
Beschreibung

consent for pharmacogenetic research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
If Yes, record the date informed consent obtained for Pharmacogenetic Research
Beschreibung

consent for pharmacogenetic research date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If No, check one reason:
Beschreibung

consent for pharmacogenetic research reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Specify other:
Beschreibung

consent for pharmacogenetic research reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Has a blood sample been collected for Pharmacogenetic Research?
Beschreibung

blood sample collection

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, record the date the sample was taken:
Beschreibung

blood sample collection date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Has this subject withdrwan consent for Pharmacogenetic Research?
Beschreibung

withdrawal of consent

Datentyp

boolean

Alias
UMLS CUI [1]
C1707492
Has a request been made for sample destruction?
Beschreibung

blood sample destruction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason:
Beschreibung

blood sample destruction reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Specify other:
Beschreibung

blood sample destruction reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Prior Medication
Beschreibung

Prior Medication

Alias
UMLS CUI-1
C0013227
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Beschreibung

If Yes, please record the medications below.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
Drug Name (Trade Name Preferred)
Beschreibung

drug name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Single Dose/Unit (e.g. 500mg)
Beschreibung

dosage

Datentyp

text

Alias
UMLS CUI [1]
C0178602
Frequency of this Dose (e.g. BID, PRN)
Beschreibung

frequency of this dose

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

administration route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Indication
Beschreibung

medication indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Duration of Therapy (e.g. 6 years)
Beschreibung

duration of therapy

Datentyp

text

Alias
UMLS CUI [1]
C0444917
End Date
Beschreibung

medication end date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Continuing at end of study?
Beschreibung

continuing medication at end of study

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
Baseline Signs Ans Symptoms
Beschreibung

Baseline Signs Ans Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline Sign/Symptom
Beschreibung

diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Onset Date and Time
Beschreibung

onset date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C2981441
UMLS CUI [1,2]
C1442488
End Date and Time
Beschreibung

end date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C2981425
UMLS CUI [1,2]
C1442488
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
Beschreibung

outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Event Course
Beschreibung

event course

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity
Beschreibung

intensity

Datentyp

text

Alias
UMLS CUI [1]
C0518690
Relationship to study procedures performed prior to randomisation
Beschreibung

relationship to study procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510821
Corrective Therapy
Beschreibung

If Yes, please record on Prior Medication form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Beschreibung

subject withdrawn due to event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
consent for pharmacogenetic research
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
consent for pharmacogenetic research date
Item
If Yes, record the date informed consent obtained for Pharmacogenetic Research
date
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, check one reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
consent for pharmacogenetic research reason
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (0)
consent for pharmacogenetic research reason
Item
Specify other:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
blood sample collection
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C0005834 (UMLS CUI [1])
blood sample collection date
Item
If Yes, record the date the sample was taken:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
withdrawal of consent
Item
Has this subject withdrwan consent for Pharmacogenetic Research?
boolean
C1707492 (UMLS CUI [1])
blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason:
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
blood sample destruction reason
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other (0)
blood sample destruction reason
Item
Specify other:
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Prior Medication
C0013227 (UMLS CUI-1)
prior medication
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C0013227 (UMLS CUI [1])
drug name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
dosage
Item
Single Dose/Unit (e.g. 500mg)
text
C0178602 (UMLS CUI [1])
frequency of this dose
Item
Frequency of this Dose (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
administration route
Item
Route
text
C0013153 (UMLS CUI [1])
medication indication
Item
Indication
text
C3146298 (UMLS CUI [1])
duration of therapy
Item
Duration of Therapy (e.g. 6 years)
text
C0444917 (UMLS CUI [1])
medication end date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
continuing medication at end of study
Item
Continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Baseline Signs Ans Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
diagnosis
Item
Baseline Sign/Symptom
text
C0011900 (UMLS CUI [1])
onset date and time
Item
Onset Date and Time
datetime
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
end date and time
Item
End Date and Time
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
text
C1705586 (UMLS CUI [1])
outcome
Code List
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
event course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Item
Intensity
text
C0518690 (UMLS CUI [1])
intensity
Code List
Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Relationship to study procedures performed prior to randomisation
text
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
relationship to study procedures
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Suspected)
CL Item
Probable (Probable)
corrective therapy
Item
Corrective Therapy
boolean
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn due to event
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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