ID

25924

Description

Study ID: 101468/204 Clinical Study ID: 101468/204 Study Title:A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00314860 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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; Restless Legs Syndrome (RLS)

Keywords

Versions (1)
  1. 9/27/17 9/27/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2017

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Creative Commons BY-NC 3.0
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GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INTERNATIONAL RLS STUDY GROUP DIAGNOSTIC CRITERIA (RLSDGC)

English

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INTERNATIONAL RLS STUDY GROUP DIAGNOSTIC CRITERIA (RLSDGC)

1 forms  
The International RLS Study Group Criteria defines RLS patients as having the following
Description

The International RLS Study Group Criteria defines RLS patients as having the following

1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Description

RLS move legs, unpleasant sensations in the legs

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1863322
UMLS CUI [1,3]
C0030554
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Description

RLS move legs, unpleasant sensations in the legs, increased while inactive

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1863322
UMLS CUI [1,3]
C0030554
UMLS CUI [1,4]
C3890554
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
Description

RLS move legs, unpleasant sensations releaved by movement

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1863322
UMLS CUI [1,3]
C0030554
UMLS CUI [1,4]
C0026649
UMLS CUI [1,5]
C1301676
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
Description

RLS move legs, unpleasant sensations worse in the evening or night

Data type

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1863322
UMLS CUI [1,3]
C0030554
UMLS CUI [1,4]
C0026649
UMLS CUI [1,5]
C3176727
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Similar models

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INTERNATIONAL RLS STUDY GROUP DIAGNOSTIC CRITERIA (RLSDGC)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
The International RLS Study Group Criteria defines RLS patients as having the following
RLS move legs, unpleasant sensations in the legs
Item
1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
boolean
C0035258 (UMLS CUI [1,1])
C1863322 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
RLS move legs, unpleasant sensations in the legs, increased while inactive
Item
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
boolean
C0035258 (UMLS CUI [1,1])
C1863322 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C3890554 (UMLS CUI [1,4])
RLS move legs, unpleasant sensations releaved by movement
Item
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
boolean
C0035258 (UMLS CUI [1,1])
C1863322 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0026649 (UMLS CUI [1,4])
C1301676 (UMLS CUI [1,5])
RLS move legs, unpleasant sensations worse in the evening or night
Item
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
boolean
C0035258 (UMLS CUI [1,1])
C1863322 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0026649 (UMLS CUI [1,4])
C3176727 (UMLS CUI [1,5])
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