ID

35680

Descrizione

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

versioni (2)
  1. 08/03/19 08/03/19 -
  2. 15/03/19 15/03/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

15 marzo 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

Inglese

Eligibility criteria

1 moduli  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Descrizione

Centre Number

Tipo di dati

integer

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

Patient Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Descrizione

Patient Initials

Tipo di dati

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descrizione

day month year

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Inclusion criteria
Descrizione

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.
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

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

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

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).
Descrizione

Contraceptive method

Tipo di dati

boolean

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

Positive pregnancy test

Tipo di dati

boolean

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

Comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0443343
UMLS CUI [2,2]
C0012634
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Similar models

Eligibility criteria

1 moduli
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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