ID

26663

Description

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Keywords

Versions (1)
  1. 10/23/17 10/23/17 -
Copyright Holder

GSK

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did patient become pregnant during the study? (mark one box below)
Description

Pregnancy

Data type

text

Alias
UMLS CUI [1]
C0032961
Did the female partner of a male patient become pregnant during the study? (mark one box below)
Description

Female Partner Pregnant

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? If 'NO' , mark the one most appropriate category
Description

Completed

Data type

boolean

Alias
UMLS CUI [1]
C0205197
Did the subject complete the study as planned? If 'NO' , mark the one most appropriate category
Description

Reason study not completed

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205257
Comments on reason for withdrawal:
Description

Withdrawal Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
Date of Withdrawal:
Description

Date of Withdrawal

Data type

boolean

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

Time of Withdrawal

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
24hr:min
Date of Final Dose:
Description

Date of Final Dose

Data type

date

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

Time of Final Dose

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1522314
24hr:min
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did patient become pregnant during the study? (mark one box below)
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did patient become pregnant during the study? (mark one box below)
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes If 'Yes' record details on Pregnancy Notification Form. (Y)
Item
Did the female partner of a male patient become pregnant during the study? (mark one box below)
text
C0919624 (UMLS CUI [1])
Female Partner Pregnant
Code List
Did the female partner of a male patient become pregnant during the study? (mark one box below)
CL Item
Not applicable (subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
No (N)
CL Item
Yes If 'Yes' record details on Pregnancy Notification Form. (Y)
Item Group
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Completed
Item
Did the subject complete the study as planned? If 'NO' , mark the one most appropriate category
boolean
C0205197 (UMLS CUI [1])
Item
Did the subject complete the study as planned? If 'NO' , mark the one most appropriate category
text
C0392360 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Reason study not completed
Code List
Did the subject complete the study as planned? If 'NO' , mark the one 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, Please specify (5)
Withdrawal Comment
Item
Comments on reason for withdrawal:
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of Withdrawal
Item
Date of Withdrawal:
boolean
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of Final Dose
Item
Date of Final Dose:
date
C1531784 (UMLS CUI [1])
Time of Final Dose
Item
Time of Final Dose:
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
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