ID

25856

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2017-09-20 2017-09-20 -
  2. 2017-09-21 2017-09-21 -
Uppladdad den

21 september 2017

DOI

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Creative Commons BY-NC 3.0
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screening inclusion and exclusion criteria Ropinirole CR Ropinirole IR Monotherapy 101468/168

Engelsk

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

1 Formulär  
ELIGIBILITY QUESTION
Beskrivning

ELIGIBILITY QUESTION

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

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.

Datatyp

text

Alias
UMLS CUI [1]
C0013893
INCLUSION CRITERIA
Beskrivning

INCLUSION CRITERIA

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

aged at least 30 years

Datatyp

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
Beskrivning

childbearing potential, contraceptive methods

Datatyp

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.)
Beskrivning

diagnosis of parkinson's disease

Datatyp

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.
Beskrivning

L-DOPA or dopamine agonists taken

Datatyp

boolean

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

exposure to ropinirole

Datatyp

boolean

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

informed consent

Datatyp

boolean

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

ability to participate the study

Datatyp

boolean

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

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.
Beskrivning

dopaminergic therapy not indicated

Datatyp

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]).
Beskrivning

other medical condition

Datatyp

boolean

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

dizziness due to postural hypotension

Datatyp

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].
Beskrivning

psychiatric diseases

Datatyp

boolean

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

dementia

Datatyp

boolean

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

neurotic behaviour, degenerative arthritis or limb amputation

Datatyp

boolean

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

alcohol or drug abuse

Datatyp

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.
Beskrivning

hypersensitivity to ropinirole

Datatyp

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.
Beskrivning

CYP1A2 inhibitors or inducers

Datatyp

boolean

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

pregnancy or breast feeding

Datatyp

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.
Beskrivning

investigational drugs used before

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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