ID

44013

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 (2)
  1. 9/5/17 9/5/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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baseline signs and symptoms PK and tolerability of ropinirole as 5 new formulations 101468/197

English

baseline signs and symptoms 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
Baseline Signs and Symptoms
Description

Baseline Signs and Symptoms

Alias
UMLS CUI-1
C0037088
Did the subject experience any symptoms prior to the first study drug administration?
Description

If YES, indicate below.

Data type

text

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C3469597
Events
Description

Events

Alias
UMLS CUI-1
C0441471
Diagnosis or signs/symptoms
Description

diagnosis or signs/symptoms

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0037088
Date and time of onset
Description

24-hour clock

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Maximum Intensity
Description

maximum intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Event course
Description

If INTERMITTENT, record the number of episodes.

Data type

text

Alias
UMLS CUI [1]
C0750729
Outcome
Description

outcome

Data type

text

Alias
UMLS CUI [1]
C1547647
Date and Time of Resolution
Description

date and time of resolution

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C2699488
Withdrawal
Description

Did the subject withdraw from study as a result of this symptom?

Data type

text

Alias
UMLS CUI [1]
C0422727
Relationship to study procedere(s)
Description

relationship to study

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439849
Corrective therapy
Description

if YES please record on the "prior medication" page

Data type

text

Alias
UMLS CUI [1]
C0087111
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Similar models

baseline signs and symptoms 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
Baseline Signs and Symptoms
C0037088 (UMLS CUI-1)
Item
Did the subject experience any symptoms prior to the first study drug administration?
text
C1457887 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
symptoms before first dose of study drug
Code List
Did the subject experience any symptoms prior to the first study drug administration?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Events
C0441471 (UMLS CUI-1)
diagnosis or signs/symptoms
Item
Diagnosis or signs/symptoms
text
C0011900 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
date and time
Item
Date and time of onset
datetime
C1264639 (UMLS CUI [1])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1])
maximum intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Event course
text
C0750729 (UMLS CUI [1])
event course
Code List
Event course
CL Item
Intermittent (I)
CL Item
Constant (C)
Item
Outcome
text
C1547647 (UMLS CUI [1])
outcome
Code List
Outcome
CL Item
Resolved (R)
CL Item
Ongoing (O)
date and time of resolution
Item
Date and Time of Resolution
datetime
C1264639 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Item
Withdrawal
text
C0422727 (UMLS CUI [1])
withdrawal
Code List
Withdrawal
CL Item
Yes (Yes)
CL Item
No (No)
Item
Relationship to study procedere(s)
integer
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
relationship to study
Code List
Relationship to study procedere(s)
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Item
Corrective therapy
text
C0087111 (UMLS CUI [1])
therapy
Code List
Corrective therapy
CL Item
Yes (Yes)
CL Item
No (No)
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