ID

40432

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 4/20/20 4/20/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 20, 2020

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License

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

English

Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Body Mass Index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
RLS Diagnostic Criteria
Description

RLS Diagnostic Criteria

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0679228
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
Description

1. a desire to move the limbs usually associated with paresthesias or dysesthesias

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0596840
UMLS CUI [1,3]
C0030554
UMLS CUI [1,4]
C0392699
2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort
Description

2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort

Data type

boolean

Alias
UMLS CUI [1]
C0700075
UMLS CUI [2,1]
C0043012
UMLS CUI [2,2]
C0596840
UMLS CUI [2,3]
C2364135
UMLS CUI [2,4]
C0564405
3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Description

3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1457868
UMLS CUI [1,3]
C0443144
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0443144
UMLS CUI [3,1]
C0564405
UMLS CUI [3,2]
C0728938
UMLS CUI [3,3]
C0026606
UMLS CUI [4,1]
C0564405
UMLS CUI [4,2]
C0205374
UMLS CUI [4,3]
C0026606
4. symptoms worse in the evening or night
Description

4. symptoms worse in the evening or night

Data type

boolean

Alias
UMLS CUI [1]
C3176727
Significant Medical / Surgical History and Physical Examination
Description

Significant Medical / Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
Description

If yes, List below one diagnosis per line. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0750502
Significant Medical / Surgical History and Physical Examination
Description

Significant Medical / Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Description

Year of first diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
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Similar models

Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (C)
CL Item
Black (B)
CL Item
Oriental (E)
CL Item
Other, please specify (O)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
RLS Diagnostic Criteria
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
Item
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort
Item
2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort
boolean
C0700075 (UMLS CUI [1])
C0043012 (UMLS CUI [2,1])
C0596840 (UMLS CUI [2,2])
C2364135 (UMLS CUI [2,3])
C0564405 (UMLS CUI [2,4])
3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Item
3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C1457887 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0564405 (UMLS CUI [3,1])
C0728938 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0564405 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0026606 (UMLS CUI [4,3])
4. symptoms worse in the evening or night
Item
4. symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1])
Item Group
Significant Medical / Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Item Group
Significant Medical / Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Past (1)
CL Item
Ongoing (2)
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