ID

25904

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. 9/26/17 9/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

English

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

1 forms  
Inform Screening
Description

Inform Screening

Subject initials
Description

initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Was this subject a screen failure?
Description

screening failure

Data type

integer

Alias
UMLS CUI [1]
C1512714
If other, please specify
Description

screening failure other reason

Data type

text

Alias
UMLS CUI [1]
C1512714
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Similar models

GSK LKA204 Ropinirole in Subjects with Restless Legs Syndrome INFORM SCREENING (SCREEN)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Was this subject a screen failure?
integer
C1512714 (UMLS CUI [1])
screening failure
Code List
Was this subject a screen failure?
CL Item
No (1)
CL Item
Yes, Adverse Event (Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.) (2)
CL Item
Yes, Lost to follow-up (4)
CL Item
Yes, Protocol violation (5)
CL Item
Yes, Subject decided to withdraw from the study (6)
CL Item
Yes, Prohibited medication use (7)
CL Item
Yes, Did not fulfill eligibility criteria (8)
CL Item
Yes, Exacerbation of medical condition under investigation. (9)
CL Item
Yes, Non-compliance (10)
CL Item
Yes, Genotype quota filled (11)
CL Item
Yes, Did not fulfill continuation criteria (12)
CL Item
Other, specify (13)
screening failure other reason
Item
If other, please specify
text
C1512714 (UMLS CUI [1])
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