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Information:
Fel:
ID
24050
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-07-24 2017-07-24 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 juli 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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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
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms
Similar models
GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
consent for pharmacogenetic research
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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])
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])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
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])
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])
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])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
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)
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])
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])
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])
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
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])
C1510821 (UMLS CUI [1,2])
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])
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])
C0877248 (UMLS CUI [1,2])