ID

35680

Beschreibung

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.

Stichworte

Versionen (2)
  1. 08.03.19 08.03.19 -
  2. 15.03.19 15.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. März 2019

DOI

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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

Englisch

Eligibility criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschreibung

Centre Number

Datentyp

integer

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Inclusion criteria
Beschreibung

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.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

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

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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).
Beschreibung

Contraceptive method

Datentyp

boolean

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

Positive pregnancy test

Datentyp

boolean

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

Comorbidity

Datentyp

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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Ähnliche Modelle

Eligibility criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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