ID

24534

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 Laboratory Collections, Pregnancy Information, Study Conclusion

Stichworte

Versionen (1)
  1. 05.08.17 05.08.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. August 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

1 Formulare  
Clinical Chemistry And Haematology
Beschreibung

Clinical Chemistry And Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Beschreibung

blood sampling date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Beschreibung

comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFCANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Beschreibung

clinical chemistry and hematology normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did patient become pregnant during the study?
Beschreibung

If YES, record details on Pregnancy Notification Form.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Did the female partner of a male patient become pregnant during the study?
Beschreibung

If YES, record details on Pregnancy Notification Form.

Datentyp

text

Alias
UMLS CUI [1]
C0919624
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject complete the study as planned?
Beschreibung

study completed

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
If NO, mark the most appropriate category
Beschreibung

withdrawal reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
If OTHER, please specify
Beschreibung

withdrawal reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
Comments on reason for withdrawal:
Beschreibung

withdrawal reason comment

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
Date of Withdrawal
Beschreibung

withdrawal date

Datentyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Time of Withdrawal
Beschreibung

withdrawal time

Datentyp

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Date of Final Dose
Beschreibung

final dose date

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Time of Final Dose
Beschreibung

final dose time

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1522314
Zum Seitenanfang zurückkehren

Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Clinical Chemistry And Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
blood sampling date and time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
clinical chemistry and hematology normal
Item
Are there CLINICALLY SIGNIFCANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0008000 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did patient become pregnant during the study?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Did patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the female partner of a male patient become pregnant during the study?
text
C0919624 (UMLS CUI [1])
pregnancy of partner
Code List
Did the female partner of a male patient become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
study completed
Item
Did the subject complete the study as planned?
boolean
C2348577 (UMLS CUI [1])
Item
If NO, mark the most appropriate category
integer
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
withdrawal reason
Code List
If NO, mark the most appropriate category
CL Item
Adverse Event (complete Adverse Event Form) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Deviation from Protocol (including non-compliance) (3)
CL Item
Lost to Follow-Up (4)
CL Item
Other (5)
withdrawal reason
Item
If OTHER, please specify
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
withdrawal reason comment
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
withdrawal date
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
withdrawal time
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
final dose date
Item
Date of Final Dose
date
C1531784 (UMLS CUI [1])
final dose time
Item
Time of Final Dose
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video