ID

26664

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

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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

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study? If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.
Description

Concomitant Medication Changes

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
CONCOMITANT MEDICATION
Description

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Drug Name (Trade Name Preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/Unit
Description

Drug Dosage

Data type

text

Alias
UMLS CUI [1]
C0870450
Frequency of this Dose (e.g. BID, PRN)
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Start Date / Time
Description

Start Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C2347852
End Date /Time
Description

End Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C2347852
Continuing at end of Study?
Description

Continuing at end of Study

Data type

boolean

Alias
UMLS CUI [1]
C1553904
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
C2347852 (UMLS CUI-1)
Concomitant Medication Changes
Item
Are there any concomitant medication CHANGES since the start of the study? If 'YES', please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Drug Dosage
Item
SINGLE Dose/Unit
text
C0870450 (UMLS CUI [1])
Frequency
Item
Frequency of this Dose (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date and Time
Item
Start Date / Time
datetime
C3897500 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
End Date and Time
Item
End Date /Time
datetime
C3899266 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Continuing at end of Study
Item
Continuing at end of Study?
boolean
C1553904 (UMLS CUI [1])
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