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24654
Beschreibung
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Inclusion/exclusion.
Stichworte
Versionen (2)
- 11.08.17 11.08.17 -
- 07.09.17 07.09.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
11. August 2017
DOI
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Creative Commons BY-NC 3.0
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Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727
Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727
Ähnliche Modelle
Inclusion/exclusion GSK study Dyskinesia in Parkinson's disease NCT00363727
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Protocol identifier
Item
Protocol identifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
text
Monitor data validation check
Item
Monitor data validation check
text
Eligibility question
Item
Did the subject meet all the entry criteria?
boolean
Item
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
text
Code List
1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age but no older than 70 at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphram IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplantt System]), during the study and for at least one month prior to randomization and one month following completion of the study.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
text
Code List
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages 1-111) and demonstrating lack of control with L-dopa therapy (e.g. mild wearing off, simple on/off fluctuations).
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
text
Code List
3. Subjects on 600 mg or less of L-dopa therapy for two years or less. Patients on combination therapy such as COMTAN/L-dopa or L-dopa and amantadine are also eligible.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
text
Code List
4. Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Item
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
text
Code List
6. Be willing and able to comply with study procedures, including follow-up clinic visits.
CL Item
failed (failed)
CL Item
fulfilled (fulfilled)
Dyskinesia
Item
1. Any stage of Parkinson's disease in which the subject demonstrates or has a history consistent with dyskinesia.
boolean
Disease
Item
2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson's Disease), or cardiovascular disease or active malignancy (other than basal cell cancer).
boolean
Abnormality
Item
3. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
boolean
dizziness or fainting
Item
4. Recent history of severe dizziness or fainting due to postural hypotension on standing.
boolean
Dementia
Item
5. Clinically relevant Dementia or a MMSE score of <26.
boolean
alcohol or drug abuse
Item
6. Recent history or current evidence of alcohol or drug abuse at the time of enrollment.
boolean
Use of MAO inhibitors
Item
7. Use of monoamine oxidase (MAO) inhibitors within three weeks of the screening visit except for the selective MAO-B inhibitor, selegiline.
boolean
adverse reactions to ropinirole
Item
8. 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 longterm dosing with ropinirole CR.
boolean
hormone replacement therapy
Item
9. 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 enrollment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrollment through the end of the Treatment Period.
boolean
Use of an investigational drug
Item
10. Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
boolean