ID

25924

Beschrijving

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)

Trefwoorden

  1. 27-09-17 27-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 september 2017

DOI

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Licentie

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)

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

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

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.
Beschrijving

RLS move legs, unpleasant sensations in the legs

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

RLS move legs, unpleasant sensations releaved by movement

Datatype

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.
Beschrijving

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

Datatype

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

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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