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ID
25805
Description
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
Versions (2)
- 9/20/17 9/20/17 -
- 9/21/17 9/21/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2017
DOI
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License
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
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Subjects aged 30 years or greater at screening. (1)
(Comment:en)
CL 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 (2)
C3831118 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
(Comment:en)
C0700589 (UMLS CUI-2)
(Comment:en)
CL Item
Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I- III.) (3)
C0030567 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL 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. (4)
C0023570 (UMLS CUI-1)
C0178601 (UMLS CUI-2)
(Comment:en)
C0178601 (UMLS CUI-2)
(Comment:en)
CL Item
No prior exposure to ropinirole. (5)
C0244821 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Provide written informed consent for this study. (6)
C0021430 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Willing and able to comply with study procedures. (7)
C0085732 (UMLS CUI-1)
C2348568 (UMLS CUI-2)
(Comment:en)
C2348568 (UMLS CUI-2)
(Comment:en)
CL Item
De novo untreated subjects with Parkinson’s disease in whom dopaminergic therapy is not warranted at the time of enrollment. (1)
C0013036 (UMLS CUI-1)
C1444655 (UMLS CUI-2)
(Comment:en)
C1444655 (UMLS CUI-2)
(Comment:en)
CL 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]). (2)
C3843040 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subjects with severe dizziness or fainting due to postural hypotension on standing. (3)
C0012833 (UMLS CUI-1)
C0020651 (UMLS CUI-2)
(Comment:en)
C0020651 (UMLS CUI-2)
(Comment:en)
CL 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]. (4)
C0004936 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation]. (5)
C0497327 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subjects with neurotic behaviour, crippling degenerative arthritis or limb amputations, which would preclude efficacy or safety assessments. (6)
C1821506 (UMLS CUI-1)
C0029408 (UMLS CUI-2)
C0002689 (UMLS CUI-3)
(Comment:en)
C0029408 (UMLS CUI-2)
C0002689 (UMLS CUI-3)
(Comment:en)
CL Item
Previous or current alcohol or drug dependence. (7)
C0085762 (UMLS CUI-1)
C0013146 (UMLS CUI-2)
(Comment:en)
C0013146 (UMLS CUI-2)
(Comment:en)
CL 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. (8)
C0020517 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
(Comment:en)
C0244821 (UMLS CUI-2)
(Comment:en)
CL 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. (9)
C1827504 (UMLS CUI-1)
C1827490 (UMLS CUI-2)
(Comment:en)
C1827490 (UMLS CUI-2)
(Comment:en)
CL Item
Women who are pregnant or breast-feeding. (10)
C0032961 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
(Comment:en)
C0006147 (UMLS CUI-2)
(Comment:en)
CL Item
Use of an investigational drug from 30 days prior to enrolment through to the end of the treatment period. (11)
C0013230 (UMLS CUI-1)
(Comment:en)
(Comment:en)