ID
26000
Beschrijving
PART B - Period 2 - 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
Trefwoorden
Versies (1)
- 03-10-17 03-10-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
3 oktober 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Body system
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Beschrijving
Body system abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Beschrijving
Describe abnormality body system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Beschrijving
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beschrijving
pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Date of pregnancy test
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Result of pregnancy test
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Beschrijving
Perform Alcohol Breath/Blood Test and attach printout
Datatype
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Beschrijving
Result of alcohol test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Beschrijving
alcohol consumption
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Beschrijving
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Beschrijving
Time of drug screening
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Beschrijving
Cannabinoids urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Beschrijving
Morphine and morphine derivates urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Beschrijving
Amphetamine urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Beschrijving
Barbiturates urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Beschrijving
Benzodiazepines urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Beschrijving
Cocaine urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Beschrijving
Tricyclic antidepressants urine
Datatype
integer
Alias
- UMLS CUI [1]
- C0003290
Beschrijving
Urine drug screening positive specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Beschrijving
Orthostatic blood pressure / Pulse - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
- UMLS CUI-4
- C3812758
Beschrijving
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.
Datatype
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C3812758
Beschrijving
Heart rate Semi-Supine
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschrijving
Heart Rate standing
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C3812758
Beschrijving
Systolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschrijving
Diastolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschrijving
Systolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C3812758
Beschrijving
Diastolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
If 'Yes', please document on the Concomitant Medication Report Forms.
Datatype
integer
Alias
- UMLS CUI [1]
- C0580105
Beschrijving
tobacco use unchanged
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Beschrijving
dietary restrictions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Beschrijving
Adverse event
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Patient diary
Alias
- UMLS CUI-1
- C3890583
Beschrijving
Patient diary
Datatype
text
Alias
- UMLS CUI [1]
- C3890583
Beschrijving
Randomization
Alias
- UMLS CUI-1
- C0034656
Beschrijving
eligibility determination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
study subject participation status eligibility
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013893
Beschrijving
Randomization
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1522541
Beschrijving
High fat breakfast
Alias
- UMLS CUI-1
- C2698559
- UMLS CUI-2
- C0521974
Beschrijving
High fat breakfast started
Datatype
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0439659
Beschrijving
The suggested time for breakfast is 20 minutes
Datatype
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0444930
Beschrijving
Breakfast completed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Beschrijving
Breakfast not completed comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Beschrijving
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Beschrijving
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschrijving
Witness 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 1
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Witness 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 2
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Orthostatic blood pressure / pulse measurement - post dose
Alias
- UMLS CUI-1
- C1095971
- UMLS CUI-2
- C0232117
- UMLS CUI-3
- C0439568
Beschrijving
Date of visit
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Post dose
Datatype
integer
Alias
- UMLS CUI [1]
- C0439568
Beschrijving
Time post dose
Datatype
time
Alias
- UMLS CUI [1,1]
- C0439568
- UMLS CUI [1,2]
- C0040223
Beschrijving
Heart rate Semi-Supine
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschrijving
Heart Rate standing
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C0439568
Beschrijving
Systolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschrijving
Diastolic blood pressure semi-supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschrijving
Systolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Beschrijving
Diastolic blood pressure standing
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Beschrijving
Adverse Event - post dosing
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschrijving
If Yes , please document on the Adverse Event Report Forms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439574
Beschrijving
If Yes , please document on the Adverse Event Report Forms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439442
Beschrijving
If Yes , please document on the Adverse Event Report Forms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439477
Beschrijving
Pharmacokinetic sampling post dosing
Alias
- UMLS CUI-1
- C0031328
Beschrijving
Sample ID and specified time
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Beschrijving
Actual time pharmacokinetics
Datatype
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Beschrijving
Date sample
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1302413
Beschrijving
Discharge
Alias
- UMLS CUI-1
- C0030685
Similar models
PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
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C0038846 (UMLS CUI [1,2])
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C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
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C1321605 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C0521974 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0521974 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0439568 (UMLS CUI-2)
C0439574 (UMLS CUI [1,2])
C1439442 (UMLS CUI [1,2])
C1439477 (UMLS CUI [1,2])
C1444698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])