ID
26100
Description
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Baseline form.
Keywords
Versions (2)
- 10/9/17 10/9/17 -
- 10/18/17 10/18/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 9, 2017
DOI
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License
Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Baseline 101468/190
GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Screening Baseline 101468/190
Description
INCLUSION/EXCLUSION CRITERIA
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Description
RLS Rating Scale
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Description
secondary RLS
Data type
boolean
Alias
- UMLS CUI [1]
- C1536279
Description
Augmentation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0473305
- UMLS CUI [1,2]
- C0454417
Description
abnormal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C0522055
- UMLS CUI [1,4]
- C0031809
Description
medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0037313
- UMLS CUI [1,3]
- C0013144
Description
blood pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
trial
Data type
boolean
Alias
- UMLS CUI [1]
- C2347449
Description
hormone replacement therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0207509
- UMLS CUI [1,2]
- C0282402
Description
RLS RATING SCALES
Alias
- UMLS CUI-1
- C0450973
- UMLS CUI-2
- C0035258
Description
RLS Rating Scale
Data type
integer
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Description
RLS Rating Scale
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0035258
Description
PATIENT RATED SCALES
Alias
- UMLS CUI-1
- C0030705
- UMLS CUI-2
- C0450973
Description
Patient related scales
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0450973
Description
VITAL SIGNS
Alias
- UMLS CUI-1
- C0518766
Description
(after 5 minutes sitting)
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
(after 5 minutes sitting)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0871470
Description
(after 5 minutes sitting)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0580946
- UMLS CUI [1,2]
- C0428883
Description
CONCOMITANT MEDICATION
Alias
- UMLS CUI-1
- C2347852
Description
MEDICAL PROCEDURES
Alias
- UMLS CUI-1
- C0199171
Description
BASELINE SIGNS AND SYMPTOMS
Alias
- UMLS CUI-1
- C0037088
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0011900
Description
no baseline event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1442488
Description
Baseline Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1442488
Description
Onset Date and Time
Data type
date
Alias
- UMLS CUI [1,1]
- C2981441
- UMLS CUI [1,2]
- C1442488
Description
End Date and Time
Data type
date
Alias
- UMLS CUI [1,1]
- C2981425
- UMLS CUI [1,2]
- C1442488
Description
If patient died, STOP: go to SAE section and follow instructions given there
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1442488
Description
Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
Description
Event Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C1442488
- UMLS CUI [1,4]
- C0332189
Description
Maximum
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442488
Description
Relationship to study procedures performed prior to randomisation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1510821
Description
If ‘Yes’, record details in Prior and ConcomitantMedication section and/or Health Care Resource Utilisation section if appropriate.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Patient withdrawn due to event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Description
BASELINE EMPLOYMENT STATUS
Alias
- UMLS CUI-1
- C0242271
- UMLS CUI-2
- C1442488
Description
Full time employment
Data type
boolean
Alias
- UMLS CUI [1]
- C0682295
Description
Part-time employment
Data type
boolean
Alias
- UMLS CUI [1]
- C0682294
Description
Part-time employment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0682294
- UMLS CUI [1,2]
- C2584953
Description
Volunteer/Unpaid work
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
Description
Volunteer/Unpaid work
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2367294
- UMLS CUI [1,2]
- C0557361
- UMLS CUI [1,3]
- C2584953
Description
Unemployed due to RLS
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0035258
Description
Unemployed due to other (NON-RLS) disability
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C0231170
Description
Unemployed for other reason
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0041674
- UMLS CUI [1,2]
- C0678226
- UMLS CUI [1,3]
- C3840932
Description
Retired
Data type
boolean
Alias
- UMLS CUI [1]
- C0035345
Description
Retired
Data type
date
Alias
- UMLS CUI [1,1]
- C0035345
- UMLS CUI [1,2]
- C0011008
Description
Homemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0555052
Description
employment
Data type
integer
Alias
- UMLS CUI [1]
- C0014003
Description
CLINICAL GLOBAL IMPRESSION
Alias
- UMLS CUI-1
- C3639708
Description
RAMOS RANDOMISATION AND DISPENSING
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0947323
- UMLS CUI-3
- C0947323
Similar models
GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Screening Baseline 101468/190
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
C0019994 (UMLS CUI [1,2])
C0680251 (UMLS CUI-2)
C0035258 (UMLS CUI [1,2])
C0454417 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0037313 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0282402 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0011900 (UMLS CUI-4)
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
C1510821 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C2584953 (UMLS CUI [1,2])
C0557361 (UMLS CUI [1,2])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0947323 (UMLS CUI-2)
C0947323 (UMLS CUI-3)
C0237753 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])