ID

25715

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation 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: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome

Keywords

Versions (1)
  1. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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concomitant medication PK and tolerability of ropinirole as 5 new formulations 101468/197

English

concomitant medication PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
Description

changes in concomitant medication

Data type

text

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C2347852
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
DRUG NAME
Description

Trade Name Preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Single Dose/Unit
Description

e.g. 500 mg

Data type

integer

Alias
UMLS CUI [1]
C1960417
Frequency of this Dose
Description

e.g. BID, PR

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

indication

Data type

text

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

24hr - clock

Data type

datetime

Alias
UMLS CUI [1]
C3897500
End Date and Time
Description

24hr - clock

Data type

datetime

Alias
UMLS CUI [1]
C3899266
Continuing at end of study?
Description

continuing therapy

Data type

text

Alias
UMLS CUI [1]
C1553904
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Similar models

concomitant medication PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
text
C0392747 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
changes in concomitant medication
Code List
Has the subj ect taken any medication after the first dose of study medication or are there any concomitant medication changes since the start of the study?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
medication name
Item
DRUG NAME
text
C2360065 (UMLS CUI [1])
single dose characteristics
Item
Single Dose/Unit
integer
C1960417 (UMLS CUI [1])
medication frequency
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
route of administration
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Indication
text
C3146298 (UMLS CUI [1])
start date and time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
end date and time
Item
End Date and Time
datetime
C3899266 (UMLS CUI [1])
Item
Continuing at end of study?
text
C1553904 (UMLS CUI [1])
continuing therapy
Code List
Continuing at end of study?
CL Item
Yes (Yes)
CL Item
No (No)
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