ID
26000
Beschreibung
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
Stichworte
Versionen (1)
- 03.10.17 03.10.17 -
Rechteinhaber
glaxoSmithKline
Hochgeladen am
3. Oktober 2017
DOI
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Lizenz
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
Beschreibung
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Body system
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Beschreibung
Body system abnormality
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Beschreibung
Describe abnormality body system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Beschreibung
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
pregnancy test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
pregnancy test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Date of pregnancy test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Result of pregnancy test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Beschreibung
Perform Alcohol Breath/Blood Test and attach printout
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Beschreibung
Result of alcohol test
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Beschreibung
alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Beschreibung
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Beschreibung
Time of drug screening
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Beschreibung
Cannabinoids urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Beschreibung
Morphine and morphine derivates urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Beschreibung
Amphetamine urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Beschreibung
Barbiturates urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Beschreibung
Benzodiazepines urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Beschreibung
Cocaine urine
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Beschreibung
Tricyclic antidepressants urine
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003290
Beschreibung
Urine drug screening positive specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Beschreibung
Orthostatic blood pressure / Pulse - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
- UMLS CUI-4
- C3812758
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C3812758
Beschreibung
Heart rate Semi-Supine
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschreibung
Heart Rate standing
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C3812758
Beschreibung
Systolic blood pressure semi-supine
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschreibung
Diastolic blood pressure semi-supine
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Beschreibung
Systolic blood pressure standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C3812758
Beschreibung
Diastolic blood pressure standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Beschreibung
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
If 'Yes', please document on the Concomitant Medication Report Forms.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0580105
Beschreibung
tobacco use unchanged
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Beschreibung
dietary restrictions
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Beschreibung
Adverse event
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Patient diary
Alias
- UMLS CUI-1
- C3890583
Beschreibung
Patient diary
Datentyp
text
Alias
- UMLS CUI [1]
- C3890583
Beschreibung
Randomization
Alias
- UMLS CUI-1
- C0034656
Beschreibung
eligibility determination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
study subject participation status eligibility
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013893
Beschreibung
Randomization
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1522541
Beschreibung
High fat breakfast
Alias
- UMLS CUI-1
- C2698559
- UMLS CUI-2
- C0521974
Beschreibung
High fat breakfast started
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0439659
Beschreibung
The suggested time for breakfast is 20 minutes
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0444930
Beschreibung
Breakfast completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Beschreibung
Breakfast not completed comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Beschreibung
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Beschreibung
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose
Datentyp
time
Maßeinheiten
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschreibung
Witness 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschreibung
Witness date 1
Datentyp
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschreibung
Witness 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschreibung
Witness date 2
Datentyp
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschreibung
Orthostatic blood pressure / pulse measurement - post dose
Alias
- UMLS CUI-1
- C1095971
- UMLS CUI-2
- C0232117
- UMLS CUI-3
- C0439568
Beschreibung
Date of visit
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Post dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439568
Beschreibung
Time post dose
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0439568
- UMLS CUI [1,2]
- C0040223
Beschreibung
Heart rate Semi-Supine
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschreibung
Heart Rate standing
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C0439568
Beschreibung
Systolic blood pressure semi-supine
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschreibung
Diastolic blood pressure semi-supine
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Beschreibung
Systolic blood pressure standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Beschreibung
Diastolic blood pressure standing
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Beschreibung
Adverse Event - post dosing
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschreibung
If Yes , please document on the Adverse Event Report Forms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439574
Beschreibung
If Yes , please document on the Adverse Event Report Forms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439442
Beschreibung
If Yes , please document on the Adverse Event Report Forms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439477
Beschreibung
Pharmacokinetic sampling post dosing
Alias
- UMLS CUI-1
- C0031328
Beschreibung
Sample ID and specified time
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Beschreibung
Actual time pharmacokinetics
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Beschreibung
Date sample
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1302413
Beschreibung
Discharge
Alias
- UMLS CUI-1
- C0030685
Ähnliche Modelle
PART B - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
C0244821 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,2])
C0279996 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
C3812758 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,2])
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])