ID

35680

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 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: 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 The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document cntains the Eligibility criteria form. It has to be filled in for screening.

Keywords

Versions (2)
  1. 3/8/19 3/8/19 -
  2. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

English

Eligibility criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

integer

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

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Patient has successfully completed study 101468/188, 190, 194 (non-US subjects only) or 218 or met the definition for relapse in the double-blind treatment phase of Study 101468/188.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Patient has given written informed consent prior to any specific study procedures.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1516637
Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner or systemic contraception (i.e., Norplant).
Description

Contraceptive method

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Patient is a woman who has a positive pregnancy test.
Description

Positive pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0240802
Patient has developed a medically unstable illness
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0443343
UMLS CUI [2,2]
C0012634
Back to the top of the page

Similar models

Eligibility criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Study Subject Participation Status
Item
Patient has successfully completed study 101468/188, 190, 194 (non-US subjects only) or 218 or met the definition for relapse in the double-blind treatment phase of Study 101468/188.
boolean
C2348568 (UMLS CUI [1])
Informed consent
Item
Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Contraceptive method
Item
Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner or systemic contraception (i.e., Norplant).
boolean
C0700589 (UMLS CUI [1])
Positive pregnancy test
Item
Patient is a woman who has a positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Comorbidity
Item
Patient has developed a medically unstable illness
boolean
C0009488 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0443343 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial