ID

36117

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Comments and Missing Data form. It can be filled in for the end of study.

Keywords

Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Comments, Missing Data

1 forms  
  1. StudyEvent: ODM
    1. Comments, Missing Data
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Visit type
Description

Tick for the itemgroup "Comments"

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Department
Description

Department

Data type

text

Alias
UMLS CUI [1]
C1704729
Number
Description

Number

Data type

integer

Alias
UMLS CUI [1]
C0237753
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Missing Data
Description

Missing Data

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Form
Description

Form

Data type

text

Alias
UMLS CUI [1]
C0348078
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C1511726
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0566251
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Similar models

Comments, Missing Data

1 forms
  1. StudyEvent: ODM
    1. Comments, Missing Data
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Date
Item
GSK Receipt Date
date
C0011008 (UMLS CUI [1])
Item Group
Comments
C0947611 (UMLS CUI-1)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Session 1 day 1 (2)
CL Item
Session 1 day 2 (3)
CL Item
Session 2 day 1  (4)
CL Item
Session 2 day 2 (5)
CL Item
Session 3 day 1 (6)
CL Item
Session 3 day 2 (7)
CL Item
Session 4 day 1 (8)
CL Item
Session 4 day 2 (9)
CL Item
Session 5 day 1 (10)
CL Item
Session 5 day 2 (11)
CL Item
Follow-up (12)
Department
Item
Department
text
C1704729 (UMLS CUI [1])
Number
Item
Number
integer
C0237753 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Item Group
Missing Data
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Form
Item
Form
text
C0348078 (UMLS CUI [1])
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit
Code List
Visit
CL Item
Screening (1)
CL Item
Session 1 day 1 (2)
CL Item
Session 1 day 2 (3)
CL Item
Session 2 day 1  (4)
CL Item
Session 2 day 2 (5)
CL Item
Session 3 day 1 (6)
CL Item
Session 3 day 2 (7)
CL Item
Session 4 day 1 (8)
CL Item
Session 4 day 2 (9)
CL Item
Session 5 day 1 (10)
CL Item
Session 5 day 2 (11)
CL Item
Follow-up (12)
Missing Data Point
Item
Missing Data Point
text
C1705492 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Reason
Item
Reason
text
C0566251 (UMLS CUI [1])
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