ID

36879

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Meals form. It has to be filled in for all study days except for follow-up.

Keywords

Versions (1)
  1. 6/18/19 6/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 18, 2019

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

Meals

1 forms  
  1. StudyEvent: ODM
    1. Meals
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study week
Description

Study week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study day
Description

Study day

Data type

integer

Alias
UMLS CUI [1]
C2826182
Meals
Description

Meals

Alias
UMLS CUI-1
C1998602
Meal Time
Description

For Day 1 only Lunch, Snack and Dinner.

Data type

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1998602
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Time served meal
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1998602
Subject finished meal in allotted time?
Description

If you tick no, please comment in the Item "Comment".

Data type

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C1522314
Subject consumed entire meal?
Description

If you tick no, please comment in the Item "Comment".

Data type

text

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Meals

1 forms
  1. StudyEvent: ODM
    1. Meals
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Study week
Code List
Study week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Day 7 (7)
CL Item
Day 8 (8)
CL Item
Day 9 (9)
CL Item
Day 10 (10)
CL Item
Day 11 (11)
CL Item
Day 12 (12)
CL Item
Day 13 (13)
CL Item
Day 14 (14)
CL Item
Day 15 (15)
CL Item
Day 16 (16)
CL Item
Day 17 (17)
CL Item
Day 18 (18)
CL Item
Day 19 (19)
Item Group
Meals
C1998602 (UMLS CUI-1)
Item
Meal Time
integer
C0040223 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Meal Time
Code List
Meal Time
CL Item
Breakfast (1)
CL Item
Lunch (2)
CL Item
Snack (3)
CL Item
Dinner (4)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time served
Item
Time served meal
time
C0040223 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
Item
Subject finished meal in allotted time?
text
C1998602 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Meal time finished
Code List
Subject finished meal in allotted time?
CL Item
Yes (Y)
CL Item
No (N)
Item
Subject consumed entire meal?
text
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Consumption entire meal
Code List
Subject consumed entire meal?
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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