ID

25303

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

  1. 8/31/17 8/31/17 -
  2. 8/31/17 8/31/17 -
  3. 9/4/17 9/4/17 -
  4. 9/4/17 9/4/17 -
  5. 9/11/17 9/11/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 31, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

drug screening and alcohol test - compare the PK and tolerability of ropinirole administered as 5 new formulations with the standard, marketed formulation 101468/197

drug screening and alcohol test - compare the PK and tolerability of ropinirole administered as 5 new formulations with the standard, marketed formulation 101468/197

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Description

focus panel

Data type

integer

Patient No
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Description

visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Treatment
Description

treatment

Data type

integer

Alias
UMLS CUI [1]
C0087111
Initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
DRUG SCREENING (URINE)
Description

DRUG SCREENING (URINE)

Alias
UMLS CUI-1
C0202274
The urine drug screen test result was?
Description

urine drug screening test result

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0456984
Time
Description

time of urine drug screen

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0456984
ALCOHOL BREATH TEST
Description

ALCOHOL BREATH TEST

Alias
UMLS CUI-1
C0202306
Was there any alcohol detected?
Description

alcohol detected

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Time
Description

time of alcohol breath test

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202306

Similar models

drug screening and alcohol test - compare the PK and tolerability of ropinirole administered as 5 new formulations with the standard, marketed formulation 101468/197

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
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Number of Visit
text
C1549755 (UMLS CUI [1])
Code List
Number of Visit
CL Item
Screening (Screening)
CL Item
Period 1/ Day -1 (Period 1/ Day -1)
CL Item
Period 2/ Day -1 (Period 2/ Day -1)
CL Item
Period 3/ Day -1 (Period 3/ Day -1)
CL Item
Period 4/ Day -1 (Period 4/ Day -1)
treatment
Item
Treatment
integer
C0087111 (UMLS CUI [1])
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
DRUG SCREENING (URINE)
C0202274 (UMLS CUI-1)
Item
The urine drug screen test result was?
text
C0202274 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
The urine drug screen test result was?
CL Item
Positive (Postive)
CL Item
Negative (Negative)
time of urine drug screen
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
ALCOHOL BREATH TEST
C0202306 (UMLS CUI-1)
alcohol detected
Item
Was there any alcohol detected?
boolean
C0001948 (UMLS CUI [1])
time of alcohol breath test
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202306 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial