ID

25916

Description

Study ID: 101468/196 Clinical Study ID: 101468/196 Study Title: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00650104 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 : Parkinson DiseaseA Long-Term, Open-Label Continuation Study of Once Daily Adminstration of Ropinirole CR Tablets to Patients with Parkinson's Disease Who Completed the Previous Ropinirole CR Studies - 167 & 164 Eligibility Criteria

Keywords

Versions (1)
  1. 9/27/17 9/27/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2017

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Creative Commons BY-NC-ND 3.0
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Eligibility Criteria Ropinirole in Parkinson's Disease GSK 101468/196

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Study Event
    1. Eligibility Criteria
All responses must be YES for the patient to be enrolled in the study.
Description

All responses must be YES for the patient to be enrolled in the study.

Alias
UMLS CUI-1
C1512693
1. Man or non-pregnant/non-breast feeding woman of at least 30 years of age. Woman of childbearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraeption [i.e. Norplant System], during the study and for at least one month prio to and one month following the study.
Description

Contraception Methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria)
Data type

boolean

Alias
UMLS CUI [1]
C0030567
3. Requiring dopaminergic therapy
Data type

boolean

Alias
UMLS CUI [1]
C3267134
4. Completed the Phase 2 ropinirole CR study 167 (according to the study-specific definition of study completion).
Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0244821
5. Provided wirtten informed consent for this study.
Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. Be willing and able to comply with study procedrures, including follow-up clinic visits.
Data type

boolean

Alias
UMLS CUI [1]
C1321605
Date informed consent signed
Data type

date

Alias
UMLS CUI [1]
C2985782
If any question is answered NO, was exemption approved by Medical Monitor?
Data type

boolean

Alias
UMLS CUI [1]
C2348482
Did Patient previously complete 3 years of study participation and attend the study completion visit on or after July 1, 2005. (If YES: Repeat all Screening assessments except for medical history/demographics, physical exam, Hoehn and Yahr staging.)
Data type

boolean

Alias
UMLS CUI [1]
C2826674
Is subject re-enrolling within 4 weeks of the Study Completion Visit? (If YES: Then ECG does not need to be repeated. If NO: Repeat ECG, and other assessments as required by protocol.)
Data type

boolean

Alias
UMLS CUI [1]
C0814875
All responses must be NO or N/A for the patient to be enrolled in the study
Description

All responses must be NO or N/A for the patient to be enrolled in the study

1. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychatric (major psychosis, severe depression, or severe dementia) hematological, renal, hepatic, endocrinological, neurological (0ther than Parkinson's Disease), or cardiovascular disease (including myocardial infarction, unstable angina pectori, cardiac arrhythmias, cerebrovascular accident [CVA], or active malignancy (other than basal cell cancer).
Data type

boolean

Alias
UMLS CUI [1]
C0009488
2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
Data type

boolean

Alias
UMLS CUI [1]
C0805162
UMLS CUI [2]
C0805162
UMLS CUI [3]
C0201975
UMLS CUI [4]
C0438154
3. Recent history of moderate to severe dizziness or faintness due to orthostatic hypotension on standing (defined as a fall in blood pressure from supine values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure).
Data type

text

Alias
UMLS CUI [1]
C0020651
4. Significant sleep disorder or screening Epworth Sleep Score >=9.
Description

Epworth Sleep Score

Data type

boolean

Alias
UMLS CUI [1]
C3541276
5. Recent history or current evidence of drug abuse or alcoholism.
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
6. 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 CR.
Description

Hypersensitivity to Ropinirole

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244821
7. Use of an investigational drug (other than ropinirole) within 30 days or 5-half-lives (which ever is longer).
Description

Investigational Drug

Data type

boolean

8. Women who are pregnant or breast-feeding.
Description

Gynaecological Status

Data type

text

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. Withdrawal from a previous ropinirole CR study (without meeting the study-specific definition of study completion).
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C2349954
If any question is answered YES, was exemption approved by Medical Monitor?
Description

Exclusion

Data type

boolean

Alias
UMLS CUI [1]
C2828389
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Study Event
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
All responses must be YES for the patient to be enrolled in the study.
C1512693 (UMLS CUI-1)
Contraception Methods
Item
1. Man or non-pregnant/non-breast feeding woman of at least 30 years of age. Woman of childbearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraeption [i.e. Norplant System], during the study and for at least one month prio to and one month following the study.
boolean
C0700589 (UMLS CUI [1])
Idiopathic Parkinson's Disease
Item
2. Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria)
boolean
C0030567 (UMLS CUI [1])
Dopaminergic Therapy
Item
3. Requiring dopaminergic therapy
boolean
C3267134 (UMLS CUI [1])
Study Participation Status: Ropinirole
Item
4. Completed the Phase 2 ropinirole CR study 167 (according to the study-specific definition of study completion).
boolean
C2348568 (UMLS CUI [1])
C0244821 (UMLS CUI [2])
Informed Consent
Item
5. Provided wirtten informed consent for this study.
boolean
C0021430 (UMLS CUI [1])
Compliance
Item
6. Be willing and able to comply with study procedrures, including follow-up clinic visits.
boolean
C1321605 (UMLS CUI [1])
Date of Informed Consent
Item
Date informed consent signed
date
C2985782 (UMLS CUI [1])
Exemption
Item
If any question is answered NO, was exemption approved by Medical Monitor?
boolean
C2348482 (UMLS CUI [1])
Study Completion
Item
Did Patient previously complete 3 years of study participation and attend the study completion visit on or after July 1, 2005. (If YES: Repeat all Screening assessments except for medical history/demographics, physical exam, Hoehn and Yahr staging.)
boolean
C2826674 (UMLS CUI [1])
Re-enrolling
Item
Is subject re-enrolling within 4 weeks of the Study Completion Visit? (If YES: Then ECG does not need to be repeated. If NO: Repeat ECG, and other assessments as required by protocol.)
boolean
C0814875 (UMLS CUI [1])
Item Group
All responses must be NO or N/A for the patient to be enrolled in the study
Comorbidity
Item
1. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychatric (major psychosis, severe depression, or severe dementia) hematological, renal, hepatic, endocrinological, neurological (0ther than Parkinson's Disease), or cardiovascular disease (including myocardial infarction, unstable angina pectori, cardiac arrhythmias, cerebrovascular accident [CVA], or active malignancy (other than basal cell cancer).
boolean
C0009488 (UMLS CUI [1])
AST, ALT, Creatinine, ECG
Item
2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine > 2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening.
boolean
C0805162 (UMLS CUI [1])
C0805162 (UMLS CUI [2])
C0201975 (UMLS CUI [3])
C0438154 (UMLS CUI [4])
Orthostatic Hypotension
Item
3. Recent history of moderate to severe dizziness or faintness due to orthostatic hypotension on standing (defined as a fall in blood pressure from supine values of 30 mmHg for systolic pressure; 20 mmHg for diastolic pressure).
text
C0020651 (UMLS CUI [1])
Epworth Sleep Score
Item
4. Significant sleep disorder or screening Epworth Sleep Score >=9.
boolean
C3541276 (UMLS CUI [1])
Substance Use Disorder
Item
5. Recent history or current evidence of drug abuse or alcoholism.
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity to Ropinirole
Item
6. 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 CR.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Investigational Drug
Item
7. Use of an investigational drug (other than ropinirole) within 30 days or 5-half-lives (which ever is longer).
boolean
Gynaecological Status
Item
8. Women who are pregnant or breast-feeding.
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Withdrawal
Item
9. Withdrawal from a previous ropinirole CR study (without meeting the study-specific definition of study completion).
boolean
C2349954 (UMLS CUI [1])
Exclusion
Item
If any question is answered YES, was exemption approved by Medical Monitor?
boolean
C2828389 (UMLS CUI [1])
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