ID

24041

Description

Module 1 - Enrolment - Previous study information and eligibility 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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

Keywords

Versions (1)
  1. 7/23/17 7/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

English

GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

1 forms  
Previous study information
Description

Previous study information

Alias
UMLS CUI-1
C2603343
UMLS CUI-2
C1533716
UMLS CUI-3
C0205156
Visite date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Previous SB Protocol Number
Description

Previous Protocol Number

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0205156
Previous Centre Number
Description

previous centre number

Data type

text

Alias
UMLS CUI [1,1]
C0019994
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0205156
Previous Patient Number
Description

The patient number used in the previous study should match the patient number on the header of this page.

Data type

text

Alias
UMLS CUI [1,1]
C1830427
UMLS CUI [1,2]
C0205156
Please complete the following inclusion criteria
Description

Please complete the following inclusion criteria

Alias
UMLS CUI-1
C1512693
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
Description

Subject completed previous study

Data type

integer

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0205156
The subject must have given written informed consent prior to any specific study procedures
Description

written informed consent

Data type

integer

Alias
UMLS CUI [1]
C0021430
Please complete the following exclusion criteria.
Description

Please complete the following exclusion criteria.

Alias
UMLS CUI-1
C0680251
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
Description

childbearing potential and no contraception

Data type

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Women who have a positive pregnancy test.
Description

pregnancy test positive

Data type

integer

Alias
UMLS CUI [1]
C0240802
Subjects who have developed any medically unstable illnesses
Description

unstable health condition

Data type

integer

Alias
UMLS CUI [1]
C4062077
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Enrolment, Previous study information and eligibility

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Previous study information
C2603343 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
visit date
Item
Visite date
date
C1320303 (UMLS CUI [1])
Previous Protocol Number
Item
Previous SB Protocol Number
text
C2348563 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
previous centre number
Item
Previous Centre Number
text
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Patient Number
Item
Previous Patient Number
text
C1830427 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Please complete the following inclusion criteria
C1512693 (UMLS CUI-1)
Item
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
integer
C2348577 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Subject completed previous study
Code List
Subjects who have successfully completed Studies 101468/191,194 (US subjects only), or 207
CL Item
yes (1 )
CL Item
no (2 )
Item
The subject must have given written informed consent prior to any specific study procedures
integer
C0021430 (UMLS CUI [1])
written informed consent
Code List
The subject must have given written informed consent prior to any specific study procedures
CL Item
yes (1 )
CL Item
no (2 )
Item Group
Please complete the following exclusion criteria.
C0680251 (UMLS CUI-1)
Item
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
integer
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
childbearing potential and no contraception
Code List
Women of childbearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant*).
CL Item
yes (1 )
CL Item
no (2 )
Item
Women who have a positive pregnancy test.
integer
C0240802 (UMLS CUI [1])
pregnancy test positive
Code List
Women who have a positive pregnancy test.
CL Item
yes (1 )
CL Item
no (2 )
Item
Subjects who have developed any medically unstable illnesses
integer
C4062077 (UMLS CUI [1])
unstable health condition
Code List
Subjects who have developed any medically unstable illnesses
CL Item
yes (1 )
CL Item
no (2 )
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