ID

24534

Description

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

Keywords

Versions (1)
  1. 8/5/17 8/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

English

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

1 forms  
Clinical Chemistry And Haematology
Description

Clinical Chemistry And Haematology

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

blood sampling date and time

Data type

datetime

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

comments

Data type

text

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

clinical chemistry and hematology normal

Data type

boolean

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

Pregnancy Information

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

If YES, record details on Pregnancy Notification Form.

Data type

text

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

If YES, record details on Pregnancy Notification Form.

Data type

text

Alias
UMLS CUI [1]
C0919624
Study Conclusion
Description

Study Conclusion

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

study completed

Data type

boolean

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

withdrawal reason

Data type

integer

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

withdrawal reason

Data type

text

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

withdrawal reason comment

Data type

text

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

withdrawal date

Data type

date

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

withdrawal time

Data type

time

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

final dose date

Data type

date

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

final dose time

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1522314
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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