Informations:
Erreur:
ID
44150
Description
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
Mots-clés
Versions (3)
- 24/09/2017 24/09/2017 -
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Détendeur de droits
glaxoSmithKline
Téléchargé le
20 septembre 2021
DOI
Pour une demande vous connecter.
Licence
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
Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Similar models
Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
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])
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])
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])
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])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C1708968 (UMLS CUI [1,2])
Medical monitor name
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
Date of approval
Item
Date
date
C2346844 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
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])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
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])
C1704258 (UMLS CUI [1,2])
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])
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)
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])
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])
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])
C0030567 (UMLS CUI [1,2])
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)
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])
C0574845 (UMLS CUI [1,2])
time of ECG
Item
Actual time of ECG reading
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
heart rate
Item
heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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])
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])
C1521902 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / Pulse
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
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])
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])
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])
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])
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])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1])
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])
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])
C0011008 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
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