ID

25485

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 (1)
  1. 9/4/17 9/4/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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screening medical history PK and tolerability of ropinirole as 5 new formulations 101468/197

English

screening medical history 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
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Ear, Nose and Throat
Description

Ear, Nose and Throat

Alias
UMLS CUI-1
C0013443
UMLS CUI-2
C0028429
UMLS CUI-3
C0031354
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Eyes
Description

Eyes

Alias
UMLS CUI-1
C0015392
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Respiratory
Description

Respiratory

Alias
UMLS CUI-1
C0035237
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Cardiovascular
Description

Cardiovascular

Alias
UMLS CUI-1
C0007226
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Gastrointestinal
Description

Gastrointestinal

Alias
UMLS CUI-1
C0012240
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Hepatobiliary and pancreas
Description

Hepatobiliary and pancreas

Alias
UMLS CUI-1
C1711359
UMLS CUI-3
C0030274
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Urology
Description

Urology

Alias
UMLS CUI-1
C0042077
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Reproduction
Description

Reproduction

Alias
UMLS CUI-1
C0035150
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Neurology
Description

Neurology

Alias
UMLS CUI-1
C0027855
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Blood and lymphatic
Description

Blood and lymphatic

Alias
UMLS CUI-1
C0851353
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Endocrine and metabolic
Description

Endocrine and metabolic

Alias
UMLS CUI-1
C0014136
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Musculoskeletal
Description

Musculoskeletal

Alias
UMLS CUI-1
C0026860
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Skin
Description

Skin

Alias
UMLS CUI-1
C1123023
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Psychiatry
Description

Psychiatry

Alias
UMLS CUI-1
C0004936
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Allergies
Description

Allergies

Alias
UMLS CUI-1
C0020517
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Others
Description

Others

Alias
UMLS CUI-1
C0205394
Description of abnormality
Description

abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Year of diagnosis
Description

year of diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Clinically relevant?
Description

abnormality clinically relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
Duration
Description

abnormality duration

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0449238
Investigator
Description

Investigator

Alias
UMLS CUI-1
C2826892
Investigator's signature
Description

investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
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screening medical history 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])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Ear, Nose and Throat
C0013443 (UMLS CUI-1)
C0028429 (UMLS CUI-2)
C0031354 (UMLS CUI-3)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Eyes
C0015392 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Respiratory
C0035237 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Cardiovascular
C0007226 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Gastrointestinal
C0012240 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Hepatobiliary and pancreas
C1711359 (UMLS CUI-1)
C0030274 (UMLS CUI-3)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Urology
C0042077 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Reproduction
C0035150 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Neurology
C0027855 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Blood and lymphatic
C0851353 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Endocrine and metabolic
C0014136 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Musculoskeletal
C0026860 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Skin
C1123023 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Psychiatry
C0004936 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Allergies
C0020517 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Others
C0205394 (UMLS CUI-1)
abnormality
Item
Description of abnormality
text
C1704258 (UMLS CUI [1])
year of diagnosis
Item
Year of diagnosis
integer
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
abnormality clinically relevant
Item
Clinically relevant?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Duration
text
C1704258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
abnormality duration
Code List
Duration
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Investigator
C2826892 (UMLS CUI-1)
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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