Informações:
Falhas:
ID
25856
Descrição
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
Palavras-chave
Versões (2)
- 20/09/2017 20/09/2017 -
- 21/09/2017 21/09/2017 -
Transferido a
21 de setembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168
screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168
Similar models
screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
CL Item
Yes (Y)
CL Item
No (N)
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])
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])
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])
C2348568 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])