ID
44181
Descripción
PART B - Period 1 - Day 1 - 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
Palabras clave
Versiones (3)
- 3/10/17 3/10/17 -
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 20/9/21 20/9/21 -
Titular de derechos de autor
glaxoSmithKline
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
age and child-bearing potential contraception
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1960468
- UMLS CUI [1,3]
- C0700589
Descripción
idiopathic Parkinson's disease Hoehn&Yahr Stage
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0865475
- UMLS CUI [1,2]
- C3639483
Descripción
study subject participation status ropinirole or candidate for dopaminergic therapy
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2]
- C3267134
Descripción
bmi
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1305855
Descripción
informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
drug dosing ropinirole
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0244821
- UMLS CUI [1,2]
- C0678766
Descripción
exemption approved
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0585836
- UMLS CUI [1,2]
- C1708968
Descripción
Medical monitor name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Descripción
Date of approval
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2346844
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
physical examination abnormality
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0035648
Descripción
psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy
Tipo de datos
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
Descripción
laboratory abnormality or ECG abnormalities
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0438215
- UMLS CUI [2]
- C0522055
Descripción
Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0166049
- UMLS CUI [2]
- C0019683
Descripción
alcohol breath test or blood test and/or urine drugs of abuse test at screening
Tipo de datos
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
Descripción
syncope or orthostatic hypotension
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0020651
- UMLS CUI [2,1]
- C0039070
- UMLS CUI [2,2]
- C0262926
Descripción
sleep disorder or Epworth Sleep Score 39
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0851578
- UMLS CUI [1,2]
- C2129304
Descripción
Abnormal diastolic arterial pressure or abnormal systolic arterial pressure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0277888
- UMLS CUI [2]
- C0277883
Descripción
L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0023570
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013036
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0262926
Descripción
hormone replacement therapy or CYP1A2 inhibitors or inducers
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3850050
- UMLS CUI [2]
- C3850068
- UMLS CUI [3]
- C0282402
Descripción
Blood donation or significant blood loss
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005795
- UMLS CUI [2]
- C3163616
Descripción
personal history, or family history, of adverse reactions or hypersensitivity to ropinirole
Tipo de datos
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
Descripción
Use of any investigational drug
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013230
Descripción
over-the-counter (OTC) medicine
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2709201
- UMLS CUI [1,2]
- C0013227
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1510472
- UMLS CUI [1,2]
- C0085762
Descripción
drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C1321605
Descripción
pregnant or breast-feeding
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Descripción
exemption approved
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0585836
- UMLS CUI [1,2]
- C1708968
Descripción
Medical monitor name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Descripción
Date of approval
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2346844
Descripción
Physical examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Body system
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Descripción
Body system abnormality
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Descripción
Describe abnormality body system
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Descripción
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Descripción
pregnancy test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0032976
Descripción
pregnancy test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0032976
Descripción
Date of pregnancy test
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Descripción
Result of pregnancy test
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0427777
Descripción
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Descripción
Perform Alcohol Breath/Blood Test and attach printout
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Descripción
Result of alcohol test
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Descripción
alcohol consumption
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Descripción
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Descripción
Time of drug screening
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Descripción
Cannabinoids urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Descripción
Morphine and morphine derivates urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Descripción
Amphetamine urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Descripción
Barbiturates urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Descripción
Benzodiazepines urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Descripción
Cocaine urine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Descripción
Tricyclic antidepressants urine
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0003290
Descripción
Urine drug screening positive specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Descripción
Orthostatic blood pressure / Pulse - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
- UMLS CUI-4
- C3812758
Descripción
For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C3812758
Descripción
Heart rate Semi-Supine
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Descripción
Heart Rate standing
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C3812758
Descripción
Systolic blood pressure semi-supine
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Descripción
Diastolic blood pressure semi-supine
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Descripción
Systolic blood pressure standing
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C3812758
Descripción
Diastolic blood pressure standing
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Descripción
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Descripción
If 'Yes', please document on the Concomitant Medication Report Forms.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0580105
Descripción
tobacco use unchanged
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Descripción
dietary restrictions
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Descripción
Adverse event
Alias
- UMLS CUI-1
- C0877248
Descripción
Patient diary
Alias
- UMLS CUI-1
- C3890583
Descripción
Patient diary
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3890583
Descripción
Randomization
Alias
- UMLS CUI-1
- C0034656
Descripción
study subject participation status eligibility
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013893
Descripción
Randomization
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1522541
Descripción
High fat breakfast
Alias
- UMLS CUI-1
- C2698559
- UMLS CUI-2
- C0521974
Descripción
High fat breakfast started
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0439659
Descripción
The suggested time for breakfast is 20 minutes
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0444930
Descripción
Breakfast completed
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Descripción
Breakfast not completed comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Descripción
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Descripción
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose
Tipo de datos
time
Unidades de medida
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Descripción
Witness 1
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Descripción
Witness date 1
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Descripción
Witness 2
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Descripción
Witness date 2
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Descripción
Orthostatic blood pressure / pulse measurement - post dose
Alias
- UMLS CUI-1
- C1095971
- UMLS CUI-2
- C0232117
- UMLS CUI-3
- C0439568
Descripción
Date of visit
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1320303
Descripción
Post dose
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0439568
Descripción
Time post dose
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0439568
- UMLS CUI [1,2]
- C0040223
Descripción
Heart rate Semi-Supine
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Descripción
Heart Rate standing
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C0439568
Descripción
Systolic blood pressure semi-supine
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Descripción
Diastolic blood pressure semi-supine
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Descripción
Systolic blood pressure standing
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Descripción
Diastolic blood pressure standing
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Descripción
Adverse Event - post dosing
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Descripción
If Yes , please document on the Adverse Event Report Forms
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439574
Descripción
If Yes , please document on the Adverse Event Report Forms
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439442
Descripción
If Yes , please document on the Adverse Event Report Forms
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439477
Descripción
Pharmacokinetic sampling post dosing
Alias
- UMLS CUI-1
- C0031328
Descripción
Sample ID and specified time
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Descripción
Actual time pharmacokinetics
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Descripción
Date sample
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1302413
Descripción
Discharge
Alias
- UMLS CUI-1
- C0030685
Descripción
Discharge Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C3864299
Descripción
Advise the subject to refrain from consuming xanthine containing beverages and foods (Coffee, tea, cola beverages, cocoa chocolate), grapefruit containing products, quinine - containing products and food containing CYP1A2-inducing constituents (Brussel sprouts, broccoli, cabbage, etc ), from 24 h before the PK evaluation day, Periods 1 and 2 in Part B, until completion of assessments 24 h afterwards
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1545257
Similar models
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
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