ID

25856

Descrizione

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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 Study Indication: Parkinson Disease

Keywords

versioni (2)
  1. 20/09/17 20/09/17 -
  2. 21/09/17 21/09/17 -
Caricato su

21 settembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168

Inglese

screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 moduli  
ELIGIBILITY QUESTION
Descrizione

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descrizione

If No, ✔ all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Tipo di dati

text

Alias
UMLS CUI [1]
C0013893
INCLUSION CRITERIA
Descrizione

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Subjects aged 30 years or greater at screening.
Descrizione

aged at least 30 years

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomisation and one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception e.g. Norplant
Descrizione

childbearing potential, contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I- III.)
Descrizione

diagnosis of parkinson's disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0030567
Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 2 weeks prior to screening.
Descrizione

L-DOPA or dopamine agonists taken

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
No prior exposure to ropinirole.
Descrizione

exposure to ropinirole

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0244821
Provide written informed consent for this study.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Willing and able to comply with study procedures.
Descrizione

ability to participate the study

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C2348568
EXCLUSION CRITERIA
Descrizione

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
De novo untreated subjects with Parkinson’s disease in whom dopaminergic therapy is not warranted at the time of enrollment.
Descrizione

dopaminergic therapy not indicated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C1444655
Subjects with severe, clinically significant condition(s) other than Parkinson’s disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson’s disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
Descrizione

other medical condition

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3843040
Subjects with severe dizziness or fainting due to postural hypotension on standing.
Descrizione

dizziness due to postural hypotension

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0012833
UMLS CUI [1,2]
C0020651
Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
Descrizione

psychiatric diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004936
Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
Descrizione

dementia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0497327
Subjects with neurotic behaviour, crippling degenerative arthritis or limb amputations, which would preclude efficacy or safety assessments.
Descrizione

neurotic behaviour, degenerative arthritis or limb amputation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1821506
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0002689
Previous or current alcohol or drug dependence.
Descrizione

alcohol or drug abuse

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0013146
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long- term dosing with ropinirole.
Descrizione

hypersensitivity to ropinirole

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244821
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
Descrizione

CYP1A2 inhibitors or inducers

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1827504
UMLS CUI [1,2]
C1827490
Women who are pregnant or breast-feeding.
Descrizione

pregnancy or breast feeding

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Use of an investigational drug from 30 days prior to enrolment through to the end of the treatment period.
Descrizione

investigational drugs used before

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013230
Ritorna all'inizio della pagina

Similar models

screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ELIGIBILITY QUESTION
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C0013893 (UMLS CUI [1])
eligibilty criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
aged at least 30 years
Item
Subjects aged 30 years or greater at screening.
boolean
C0001779 (UMLS CUI [1])
childbearing potential, contraceptive methods
Item
Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomisation and one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception e.g. Norplant
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
diagnosis of parkinson's disease
Item
Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I- III.)
boolean
C0030567 (UMLS CUI [1])
L-DOPA or dopamine agonists taken
Item
Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 2 weeks prior to screening.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
exposure to ropinirole
Item
No prior exposure to ropinirole.
boolean
C0244821 (UMLS CUI [1])
informed consent
Item
Provide written informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
ability to participate the study
Item
Willing and able to comply with study procedures.
boolean
C0085732 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
dopaminergic therapy not indicated
Item
De novo untreated subjects with Parkinson’s disease in whom dopaminergic therapy is not warranted at the time of enrollment.
boolean
C0013036 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
other medical condition
Item
Subjects with severe, clinically significant condition(s) other than Parkinson’s disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson’s disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
boolean
C3843040 (UMLS CUI [1])
dizziness due to postural hypotension
Item
Subjects with severe dizziness or fainting due to postural hypotension on standing.
boolean
C0012833 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
psychiatric diseases
Item
Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
boolean
C0004936 (UMLS CUI [1])
dementia
Item
Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
boolean
C0497327 (UMLS CUI [1])
neurotic behaviour, degenerative arthritis or limb amputation
Item
Subjects with neurotic behaviour, crippling degenerative arthritis or limb amputations, which would preclude efficacy or safety assessments.
boolean
C1821506 (UMLS CUI [1])
C0029408 (UMLS CUI [2])
C0002689 (UMLS CUI [3])
alcohol or drug abuse
Item
Previous or current alcohol or drug dependence.
boolean
C0085762 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
hypersensitivity to ropinirole
Item
Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long- term dosing with ropinirole.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
CYP1A2 inhibitors or inducers
Item
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
boolean
C1827504 (UMLS CUI [1,1])
C1827490 (UMLS CUI [1,2])
pregnancy or breast feeding
Item
Women who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
investigational drugs used before
Item
Use of an investigational drug from 30 days prior to enrolment through to the end of the treatment period.
boolean
C0013230 (UMLS CUI [1])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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