ID

26293

Beskrivning

Study Part: Eligibility Checklist Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Nyckelord

Versioner (1)
  1. 2017-10-15 2017-10-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Eligibility Checklist Screening Ropinirole Parkinson Disease 101468/165

Engelsk

Eligibility Checklist Screening

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patient number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Centre Number
Beskrivning

Centre Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
1. Is the subject aged 30 years or greater at screening visit?
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. If the subject is a female of childbearing potential, is the subject practising a clinically accepted method of contraception during the study and for at least one month prior to Day 1, 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 in the male partner, or systemic contraception (e.g., Norplant System).
Beskrivning

contraceptive methods

Datatyp

text

Alias
UMLS CUI [1]
C0700589
3. Has the subject a diagnosis of idiopathic Parkinson’s Disease according to modified Hoehn & Yahr Stage I-III?
Beskrivning

idiopathic Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0865475
4. Has the subject provided written infomed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study?
Beskrivning

informed consent; concomitant medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2347852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Has the subject a presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neuological (other than Parkinson’s Disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or active malignancy (other than basal cell cancer)?
Beskrivning

comorbidity Mental disorders Hematological Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0018939
2. Has the subject an aspartate aminotransferase (ALT), alanine aminotransferase (ALT), or serum creatinine >2 x the upper limit of normal (ULN) or other clinically significant laboratory or ECG abnormalities at screening?
Beskrivning

Laboratory test result abnormal aspartate aminotransferase serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0004002
UMLS CUI [1,3]
C0201976
3. Has the subject positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody?
Beskrivning

Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
4. Has the subject a resent history (within the last 6 months) of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the semi-supine to standing posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure?
Beskrivning

syncope; orthostatic hypotension; Blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0039070
UMLS CUI [2]
C0020651
UMLS CUI [3]
C0005823
5. Has the subject a significant sleep disorder or screening Epworth Sleep Score ≥ 9?
Beskrivning

sleep disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0851578
6. Has the subject a diastolic blood pressure ≥110 mmHg or ≤50 mmHg OR systolic blood pressure ≥180 mmHg or ≤90 mmHg at pre-dose?
Beskrivning

blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
7. Is the subject currently receiving any L-dopa preparation? (L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication)
Beskrivning

L-dopa preparation

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
8. Has the subject a history of any dopaminergic treatments within 2 weeks prior to dosing with study medication? (Note: Patients on dopaminergic agonists may be enrolled if the agent is stopped for a 2-week wash-out period prior to dosing with study medication. Patients on selegiline, amantadine,or anticholinergics may be erolled but must remain on their current dose during study participation).
Beskrivning

concomitant medication dopaminergic agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0178601
9. Has the subject a history of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT or fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 14 days prior to dosing with study medication? If yes, patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to dosing with study medication through the end of the down-titration portion of the Treatment Period. ( If this is applicable please tick N/A box and complete prior medication page)
Beskrivning

concomitant medication CYP1A2

Datatyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0207509
10. Has the subject definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure?
Beskrivning

adverse event ropinirole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0244821
11. Has the subject had previous dose related AE’s to dopaminergic agents, or adverse events related to dyskinesias?
Beskrivning

adverse event Dopaminergic Agents dyskinesias

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013036
UMLS CUI [1,3]
C0013384
12. Has the subject had use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing?
Beskrivning

concomitant medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
13. Has the subject donated blood or had a significant blood loss less than 90 days prior to dosing with study medication?
Beskrivning

blood donation; Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0019080
14. Has the subject a recent history (within the last 6 months), or suspicion, of drug dependence or abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women)? One unit is equivalent to half a pint of beer, one measure of spirts or one glass of wine
Beskrivning

substance abuse disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
15. Is there significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures?
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
16. Is the subject a female who is pregnant or breast-feeding?
Beskrivning

pregnancy; lactating

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Checklist Screening

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
age
Item
1. Is the subject aged 30 years or greater at screening visit?
boolean
C0001779 (UMLS CUI [1])
Item
2. If the subject is a female of childbearing potential, is the subject practising a clinically accepted method of contraception during the study and for at least one month prior to Day 1, 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 in the male partner, or systemic contraception (e.g., Norplant System).
text
C0700589 (UMLS CUI [1])
contraceptive methods
Code List
2. If the subject is a female of childbearing potential, is the subject practising a clinically accepted method of contraception during the study and for at least one month prior to Day 1, 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 in the male partner, or systemic contraception (e.g., Norplant System).
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
idiopathic Parkinson Disease
Item
3. Has the subject a diagnosis of idiopathic Parkinson’s Disease according to modified Hoehn & Yahr Stage I-III?
boolean
C0865475 (UMLS CUI [1])
informed consent; concomitant medication
Item
4. Has the subject provided written infomed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study?
boolean
C0021430 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
comorbidity Mental disorders Hematological Disease
Item
1. Has the subject a presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neuological (other than Parkinson’s Disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or active malignancy (other than basal cell cancer)?
boolean
C0009488 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
Laboratory test result abnormal aspartate aminotransferase serum creatinine
Item
2. Has the subject an aspartate aminotransferase (ALT), 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
C0438215 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0201976 (UMLS CUI [1,3])
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV Seropositivity
Item
3. Has the subject positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody?
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
syncope; orthostatic hypotension; Blood pressure
Item
4. Has the subject a resent history (within the last 6 months) of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the semi-supine to standing posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure?
boolean
C0039070 (UMLS CUI [1])
C0020651 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
sleep disorder
Item
5. Has the subject a significant sleep disorder or screening Epworth Sleep Score ≥ 9?
boolean
C0851578 (UMLS CUI [1])
blood pressure
Item
6. Has the subject a diastolic blood pressure ≥110 mmHg or ≤50 mmHg OR systolic blood pressure ≥180 mmHg or ≤90 mmHg at pre-dose?
boolean
C0005823 (UMLS CUI [1])
L-dopa preparation
Item
7. Is the subject currently receiving any L-dopa preparation? (L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication)
boolean
C0023570 (UMLS CUI [1])
concomitant medication dopaminergic agonists
Item
8. Has the subject a history of any dopaminergic treatments within 2 weeks prior to dosing with study medication? (Note: Patients on dopaminergic agonists may be enrolled if the agent is stopped for a 2-week wash-out period prior to dosing with study medication. Patients on selegiline, amantadine,or anticholinergics may be erolled but must remain on their current dose during study participation).
boolean
C2347852 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
Item
9. Has the subject a history of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT or fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 14 days prior to dosing with study medication? If yes, patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to dosing with study medication through the end of the down-titration portion of the Treatment Period. ( If this is applicable please tick N/A box and complete prior medication page)
text
C2347852 (UMLS CUI [1,1])
C0207509 (UMLS CUI [1,2])
contraceptive methods
Code List
9. Has the subject a history of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT or fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 14 days prior to dosing with study medication? If yes, patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to dosing with study medication through the end of the down-titration portion of the Treatment Period. ( If this is applicable please tick N/A box and complete prior medication page)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
adverse event ropinirole
Item
10. Has the subject definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure?
boolean
C0877248 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
adverse event Dopaminergic Agents dyskinesias
Item
11. Has the subject had previous dose related AE’s to dopaminergic agents, or adverse events related to dyskinesias?
boolean
C0877248 (UMLS CUI [1,1])
C0013036 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
concomitant medication
Item
12. Has the subject had use of any investigational drug (with the exception of ropinirole CR) within the 30 days or 5 half-lives (whichever is longer) before the start of study medication dosing?
boolean
C2347852 (UMLS CUI [1])
blood donation; Hemorrhage
Item
13. Has the subject donated blood or had a significant blood loss less than 90 days prior to dosing with study medication?
boolean
C0005794 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
substance abuse disorders
Item
14. Has the subject a recent history (within the last 6 months), or suspicion, of drug dependence or abuse of alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women)? One unit is equivalent to half a pint of beer, one measure of spirts or one glass of wine
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
15. Is there significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures?
boolean
C2348568 (UMLS CUI [1])
pregnancy; lactating
Item
16. Is the subject a female who is pregnant or breast-feeding?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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