ID

44150

Beschreibung

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

Versionen (3)
  1. 24.09.17 24.09.17 -
  2. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  3. 20.09.21 20.09.21 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Englisch

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Beschreibung

age and child-bearing potential contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1960468
UMLS CUI [1,3]
C0700589
Diagnosis of idiopathic Parkinson's disease according to modified Hoehn & Yahr Stage I-III.
Beschreibung

idiopathic Parkinson's disease Hoehn&Yahr Stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0865475
UMLS CUI [1,2]
C3639483
Currently participating in the open-label ropinirole CR Study 196 or a candidate for dopaminergic therapy.
Beschreibung

study subject participation status ropinirole or candidate for dopaminergic therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0244821
UMLS CUI [2]
C3267134
Have a body mass index (BMI=weight kg/height m2) within the range 19 to 33 kg x m2.
Beschreibung

bmi

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Provide written informed consent prior to performing any screening assessments, including any washout of concomitant medications in preparation for this study.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
If any question is answered NO, was exemption approved by Medical Monitor?
Beschreibung

exemption approved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585836
UMLS CUI [1,2]
C1708968
Approved by
Beschreibung

Medical monitor name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date
Beschreibung

Date of approval

Datentyp

date

Alias
UMLS CUI [1]
C2346844
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Beschreibung

physical examination abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0035648
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).
Beschreibung

psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0027765
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0006826
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.
Beschreibung

laboratory abnormality or ECG abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
Positive results for serum Hepatitis B surface antigen, Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody.
Beschreibung

Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0166049
UMLS CUI [2]
C0019683
Positive results for alcohol breath test or blood test and/or urine drugs of abuse test at screening.
Beschreibung

alcohol breath test or blood test and/or urine drugs of abuse test at screening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1710477
UMLS CUI [1,3]
C1167994
UMLS CUI [1,4]
C1710477
UMLS CUI [2,1]
C0451130
UMLS CUI [2,2]
C1710477
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.
Beschreibung

syncope or orthostatic hypotension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C0262926
Significant sleep disorder or screening Epworth Sleep Score 39.
Beschreibung

sleep disorder or Epworth Sleep Score 39

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C2129304
Diastolic blood pressure >110 mmHg or <50 mmHg OR systolic blood pressure >180 mmHg or <90 mmHg at baseline.
Beschreibung

Abnormal diastolic arterial pressure or abnormal systolic arterial pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0277888
UMLS CUI [2]
C0277883
Currently receiving any L-dopa dose or preparation.
Beschreibung

L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0023570
History of any dopaminergic treatments (excluding ropinirole CR) within 2 weeks prior to enrolment.
Beschreibung

Note: Patients on dopaminergic agonists other than ropinirole CR may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrolment. Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0262926
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.
Beschreibung

hormone replacement therapy or CYP1A2 inhibitors or inducers

Datentyp

boolean

Alias
UMLS CUI [1]
C3850050
UMLS CUI [2]
C3850068
UMLS CUI [3]
C0282402
Blood donation or significant blood loss less than 90 days before the present study.
Beschreibung

Blood donation or significant blood loss

Datentyp

boolean

Alias
UMLS CUI [1]
C0005795
UMLS CUI [2]
C3163616
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Beschreibung

personal history, or family history, of adverse reactions or hypersensitivity to ropinirole

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0244821
UMLS CUI [1,3]
C0241889
UMLS CUI [1,4]
C0559546
UMLS CUI [1,5]
C0244821
UMLS CUI [1,6]
C0241889
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0244821
UMLS CUI [2,3]
C0332119
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0244821
UMLS CUI [3,3]
C0332119
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.
Beschreibung

Use of any investigational drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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.
Beschreibung

over-the-counter (OTC) medicine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2709201
UMLS CUI [1,2]
C0013227
Recent history, or suspicion, of drug dependence or abuse of alcohol.
Beschreibung

With alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of 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 spirits, or one glass of wine.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1510472
UMLS CUI [1,2]
C0085762
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.
Beschreibung

drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1321605
Women who are pregnant or breast-feeding
Beschreibung

pregnant or breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
If any question is answered NO, was exemption approved by Medical Monitor?
Beschreibung

exemption approved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585836
UMLS CUI [1,2]
C1708968
Approved by
Beschreibung

Medical monitor name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date
Beschreibung

Date of approval

Datentyp

date

Alias
UMLS CUI [1]
C2346844
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Please specify other racial group.
Beschreibung

Other race specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Medical history
Beschreibung

Medical history

Alias
UMLS CUI-1
C0262926
Body system
Beschreibung

Body system

Datentyp

integer

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0449913
Body system
Beschreibung

Body system abnormality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Describe abnormality
Beschreibung

Describe abnormality body system

Datentyp

text

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0678257
Surgical history: Parkinson's disease
Beschreibung

Surgical history: Parkinson's disease

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0455610
Surgical Procedures related to Parkinson's Disease
Beschreibung

If yes, please specify.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0455610
Date
Beschreibung

Date of surgical procedure Parkinson's disease

Datentyp

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0030567
Procedure
Beschreibung

Surgical procedure Parkinson's disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
Allergies
Beschreibung

Allergies

Alias
UMLS CUI-1
C0020517
Allergies
Beschreibung

If yes, please specify.

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
Allergen
Beschreibung

Allergen

Datentyp

text

Alias
UMLS CUI [1]
C0002092
Reaction
Beschreibung

Allergic reaction

Datentyp

text

Alias
UMLS CUI [1]
C1527304
Parkinson's disease history
Beschreibung

Parkinson's disease history

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0262926
Date of Onset of Symptoms of Parkinson's Disease
Beschreibung

Date of Onset Parkinson's Disease

Datentyp

date

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0574845
12-lead electrocardiogram report
Beschreibung

12-lead electrocardiogram report

Alias
UMLS CUI-1
C0430456
Actual time of ECG reading
Beschreibung

time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
heart rate
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
bpm
P-R interval
Beschreibung

P-R interval

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Interval
Beschreibung

QRS Interval

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QTc interval
Beschreibung

QTc interval

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0855331
sec
Overall ECG results
Beschreibung

ECG results

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1274040
If abnormal - clinically significant, describe
Beschreibung

Specify ECG abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C1521902
Orthostatic blood pressure / Pulse
Beschreibung

Orthostatic blood pressure / Pulse

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
Screening date of visit
Beschreibung

Screening date of visit

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1710477
Heart Rate semi-supine
Beschreibung

Heart rate Semi-Supine

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Heart Rate standing
Beschreibung

Heart Rate standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
Systolic blood pressure semi-supine
Beschreibung

Systolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic blood pressure semi-supine
Beschreibung

Diastolic blood pressure semi-supine

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Systolic blood pressure standing
Beschreibung

Systolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Diastolic blood pressure standing
Beschreibung

Diastolic blood pressure standing

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Pregnancy test
Beschreibung

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Beschreibung

pregnancy test

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
If yes, what type of pregnancy test was performed?
Beschreibung

pregnancy test

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Date of pregnancy test
Beschreibung

Date of pregnancy test

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result
Beschreibung

Result of pregnancy test

Datentyp

integer

Alias
UMLS CUI [1]
C0427777
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Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
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 Group
Exclusion Criteria
C0680251 (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 Group
Demographics
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Caucasian (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Hispanic (4)
CL Item
other (5)
Other race specify
Item
Please specify other racial group.
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Medical history
C0262926 (UMLS CUI-1)
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Hematopoietic and lymphatic (9)
CL Item
Endocrine and metabolic (10)
CL Item
other (11)
Item
Body system
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Body system abnormality
Code List
Body system
CL Item
normal (1)
CL Item
abnormal (2)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Surgical history: Parkinson's disease
C0030567 (UMLS CUI-1)
C0455610 (UMLS CUI-2)
Surgical Procedures Parkinson's Disease
Item
Surgical Procedures related to Parkinson's Disease
boolean
C0030567 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
Date of surgical procedure Parkinson's disease
Item
Date
date
C0543467 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Surgical procedure Parkinson's disease
Item
Procedure
text
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Item Group
Allergies
C0020517 (UMLS CUI-1)
Allergies
Item
Allergies
boolean
C0020517 (UMLS CUI [1])
Allergen
Item
Allergen
text
C0002092 (UMLS CUI [1])
Allergic reaction
Item
Reaction
text
C1527304 (UMLS CUI [1])
Item Group
Parkinson's disease history
C0030567 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of Onset Parkinson's Disease
Item
Date of Onset of Symptoms of Parkinson's Disease
date
C0030567 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item Group
12-lead electrocardiogram report
C0430456 (UMLS CUI-1)
time of ECG
Item
Actual time of ECG reading
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
heart rate
Item
heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
P-R interval
Item
P-R interval
float
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
float
C0520880 (UMLS CUI [1])
QTc interval
Item
QTc interval
float
C0855331 (UMLS CUI [1])
Item
Overall ECG results
integer
C1623258 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
ECG results
Code List
Overall ECG results
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Specify ECG abnormality
Item
If abnormal - clinically significant, describe
text
C0522055 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / Pulse
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
Screening date of visit
Item
Screening date of visit
date
C1320303 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
If yes, what type of pregnancy test was performed?
CL Item
Serum (1)
CL Item
Urine (2)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result
CL Item
positive (1)
CL Item
negative (2)
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