Date medication start
Item
Date this subject started on ropinirole 8mg OD
date
C3173309 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
age and child-bearing potential contraception
Item
Men or women 30 to 85 years of age, inclusive, at screening. Women of child-bearing potential must be practising a clinically accepted method of contraception (such as oral contraception, surgical sterilisation, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on the male partner, or systemic contraception [i.e. Norplant System]), during the study and for at least one month prior to randomization and one month following completion of the study.
boolean
C0001779 (UMLS CUI [1,1])
C1960468 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
idiopathic Parkinson's disease Hoehn&Yahr Stage
Item
Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
boolean
C0865475 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
study subject participation status ropinirole or candidate for dopaminergic therapy
Item
Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
boolean
C2348568 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C3267134 (UMLS CUI [2])
bmi
Item
Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
boolean
C1305855 (UMLS CUI [1])
informed consent
Item
Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
boolean
C0021430 (UMLS CUI [1])
drug dosing ropinirole
Item
Has been taking 8mg ropinirole CR daily for at least 3 days.
boolean
C0244821 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
exemption approved
Item
If any question is answered NO, was exemption approved by Medical Monitor?
boolean
C0585836 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of approval
Item
Date
date
C2346844 (UMLS CUI [1])
physical examination abnormality
Item
Patients who have an abnormality on physical examination. A patient with clinical abnormality may be included only if the Investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2])
psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy
Item
Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (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
C0004936 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5,1])
C0027765 (UMLS CUI [5,2])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
laboratory abnormality or ECG abnormalities
Item
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
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody
Item
Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
boolean
C0019168 (UMLS CUI [1,1])
C0166049 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
alcohol breath test or blood test and/or urine drugs of abuse test at screening
Item
Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
boolean
C0202306 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1167994 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,4])
C0451130 (UMLS CUI [2,1])
C1710477 (UMLS CUI [2,2])
syncope or orthostatic hypotension
Item
Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure, after rising from the supine to erect posture, of > 30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
boolean
C0020651 (UMLS CUI [1])
C0039070 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
sleep disorder or Epworth Sleep Score 39
Item
Significant sleep disorder or screening Epworth Sleep Score 39.
boolean
C0851578 (UMLS CUI [1,1])
C2129304 (UMLS CUI [1,2])
Abnormal diastolic arterial pressure or abnormal systolic arterial pressure
Item
Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
boolean
C0277888 (UMLS CUI [1])
C0277883 (UMLS CUI [2])
Treatment with L-Dopa
Item
Currently receiving any L-dopa dose or preparation.
boolean
C0013227 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
History of any dopaminergic treatments
Item
History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
boolean
C0013036 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
hormone replacement therapy or 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., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
boolean
C3850050 (UMLS CUI [1])
C3850068 (UMLS CUI [2])
C0282402 (UMLS CUI [3])
Blood donation or significant blood loss
Item
Blood donation or significant blood loss less than 90 days before the present study.
boolean
C0005795 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
personal history, or family history, of adverse reactions or hypersensitivity to ropinirole
Item
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0559546 (UMLS CUI [1,4])
C0244821 (UMLS CUI [1,5])
C0241889 (UMLS CUI [1,6])
C0020517 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
C0332119 (UMLS CUI [2,3])
C0559546 (UMLS CUI [3,1])
C0244821 (UMLS CUI [3,2])
C0332119 (UMLS CUI [3,3])
Use of any investigational drug
Item
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
C0013230 (UMLS CUI [1])
over-the-counter (OTC) medicine
Item
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
boolean
C2709201 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
drug dependence or abuse of alcohol
Item
Recent history, or suspicion, of drug dependence or abuse of alcohol.
boolean
C1510472 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour
Item
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
C2347852 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
pregnant or breast-feeding
Item
Women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
exemption approved
Item
If any question is answered NO, was exemption approved by Medical Monitor?
boolean
C0585836 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of approval
Item
Date
date
C2346844 (UMLS CUI [1])
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Genitourinary (8)
CL Item
Hematopoietic and lymphatic (9)
CL Item
Endocrine and metabolic (10)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Body system abnormality
CL Item
not done/ not applicable (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result
integer
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Item
Cannabinoids
integer
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Code List
Morphine and morphine derivates
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Code List
Tricyclic antidepressants
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
Code List
Has the subject had any changes in medication since the last study visit?
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Code List
Have the subject's smoking habits remained unchanged?
Item
Has the subject complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Code List
Has the subject complied with suggested dietary restrictions?
study subject participation status eligibility
Item
Does the subject continue to meet criteria for enrolment in the study?
boolean
C2348568 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Item
Please indicate (x) Treatment Sequence this subject is randomized to:
integer
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Code List
Please indicate (x) Treatment Sequence this subject is randomized to:
CL Item
Treatment Sequence 1 (CR-IR): Period 1 CR, Period 2 IR (1)
CL Item
Treatment Sequence 2 (IR-CR): Period 1 IR, Period 2 CR (2)
Breakfast started
Item
Breakfast started
time
C2698559 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Breakfast ended
Item
Breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Breakfast completed
Item
Did the subject complete the breakfast?
boolean
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Item
Dosage
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Time post dose
Item
Time of post dose
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])