ID

25710

Beschrijving

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

Trefwoorden

Versies (1)
  1. 12-09-17 12-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 september 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

Engels

visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beschrijving

focus panel

Datatype

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Date
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Number of Visit
Beschrijving

visit number

Datatype

text

Alias
UMLS CUI [1]
C1549755
Treatment
Beschrijving

treatment

Datatype

text

Alias
UMLS CUI [1]
C0087111
Meals and Fluids
Beschrijving

Meals and Fluids

Alias
UMLS CUI-1
C0518009
Was meal in take according to the protocol?
Beschrijving

If no, please specify

Datatype

boolean

Alias
UMLS CUI [1,1]
C0458244
UMLS CUI [1,2]
C0525058
Meals and Fluids: Day 1
Beschrijving

Meals and Fluids: Day 1

Alias
UMLS CUI-1
C0518009
Scheduled time
Beschrijving

scheduled time

Datatype

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Scheduled time followed?
Beschrijving

time protocol compliant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0525058
Comments
Beschrijving

comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Meals and Fluids: Day 2
Beschrijving

Meals and Fluids: Day 2

Alias
UMLS CUI-1
C0518009
Scheduled time
Beschrijving

scheduled time

Datatype

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Scheduled time followed?
Beschrijving

time protocol compliant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0525058
Comments
Beschrijving

comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Comments
Beschrijving

Comments

Alias
UMLS CUI-1
C0947611
Comments
Beschrijving

comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Initials
Beschrijving

Initials

Alias
UMLS CUI-1
C2986440
Initials
Beschrijving

initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Terug naar het begin van de pagina

Similar models

visit period 1,2,3 & 4 meals and fluids day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Number of Visit
text
C1549755 (UMLS CUI [1])
visit number
Code List
Number of Visit
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
text
C0087111 (UMLS CUI [1])
Item Group
Meals and Fluids
C0518009 (UMLS CUI-1)
meal intake according to the protocol
Item
Was meal in take according to the protocol?
boolean
C0458244 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item Group
Meals and Fluids: Day 1
C0518009 (UMLS CUI-1)
Item
Scheduled time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
scheduled time
Code List
Scheduled time
CL Item
+4: 15 h / lunch (+4: 15 h / lunch)
CL Item
+9:00 h / dinner (+9:00 h / dinner)
CL Item
+ 12:15 h / snack (+ 12:15 h / snack)
time protocol compliant
Item
Scheduled time followed?
boolean
C0040223 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Meals and Fluids: Day 2
C0518009 (UMLS CUI-1)
Item
Scheduled time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
scheduled time
Code List
Scheduled time
CL Item
breakfast (breakfast)
CL Item
lunch (lunch)
CL Item
dinner (dinner)
time protocol compliant
Item
Scheduled time followed?
boolean
C0040223 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Comments
C0947611 (UMLS CUI-1)
comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Initials
C2986440 (UMLS CUI-1)
initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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