ID
26000
Description
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
Mots-clés
Versions (1)
- 03/10/2017 03/10/2017 -
Détendeur de droits
glaxoSmithKline
Téléchargé le
3 octobre 2017
DOI
Pour une demande vous connecter.
Licence
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
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Body system
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Description
Body system abnormality
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Description
Describe abnormality body system
Type de données
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Description
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Description
pregnancy test
Type de données
integer
Alias
- UMLS CUI [1]
- C0032976
Description
pregnancy test
Type de données
integer
Alias
- UMLS CUI [1]
- C0032976
Description
Date of pregnancy test
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Result of pregnancy test
Type de données
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Description
Perform Alcohol Breath/Blood Test and attach printout
Type de données
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Description
Result of alcohol test
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Description
alcohol consumption
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Description
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Description
Time of drug screening
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Description
Cannabinoids urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Description
Morphine and morphine derivates urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Description
Amphetamine urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Description
Barbiturates urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Description
Benzodiazepines urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Description
Cocaine urine
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Description
Tricyclic antidepressants urine
Type de données
integer
Alias
- UMLS CUI [1]
- C0003290
Description
Urine drug screening positive specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Description
Orthostatic blood pressure / Pulse - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
- UMLS CUI-4
- C3812758
Description
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.
Type de données
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C3812758
Description
Heart rate Semi-Supine
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Heart Rate standing
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C3812758
Description
Systolic blood pressure semi-supine
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Diastolic blood pressure semi-supine
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Systolic blood pressure standing
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C3812758
Description
Diastolic blood pressure standing
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
If 'Yes', please document on the Concomitant Medication Report Forms.
Type de données
integer
Alias
- UMLS CUI [1]
- C0580105
Description
tobacco use unchanged
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Description
dietary restrictions
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Description
Adverse event
Alias
- UMLS CUI-1
- C0877248
Description
Patient diary
Alias
- UMLS CUI-1
- C3890583
Description
Patient diary
Type de données
text
Alias
- UMLS CUI [1]
- C3890583
Description
Randomization
Alias
- UMLS CUI-1
- C0034656
Description
eligibility determination
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
study subject participation status eligibility
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013893
Description
Randomization
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1522541
Description
High fat breakfast
Alias
- UMLS CUI-1
- C2698559
- UMLS CUI-2
- C0521974
Description
High fat breakfast started
Type de données
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0439659
Description
The suggested time for breakfast is 20 minutes
Type de données
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0444930
Description
Breakfast completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Description
Breakfast not completed comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Description
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Description
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose
Type de données
time
Unités de mesure
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Witness 1
Type de données
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Description
Witness date 1
Type de données
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Description
Witness 2
Type de données
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Description
Witness date 2
Type de données
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Description
Orthostatic blood pressure / pulse measurement - post dose
Alias
- UMLS CUI-1
- C1095971
- UMLS CUI-2
- C0232117
- UMLS CUI-3
- C0439568
Description
Date of visit
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Post dose
Type de données
integer
Alias
- UMLS CUI [1]
- C0439568
Description
Time post dose
Type de données
time
Alias
- UMLS CUI [1,1]
- C0439568
- UMLS CUI [1,2]
- C0040223
Description
Heart rate Semi-Supine
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Heart Rate standing
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C0439568
Description
Systolic blood pressure semi-supine
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Diastolic blood pressure semi-supine
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Systolic blood pressure standing
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Description
Diastolic blood pressure standing
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Description
Adverse Event - post dosing
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If Yes , please document on the Adverse Event Report Forms
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439574
Description
If Yes , please document on the Adverse Event Report Forms
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439442
Description
If Yes , please document on the Adverse Event Report Forms
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439477
Description
Pharmacokinetic sampling post dosing
Alias
- UMLS CUI-1
- C0031328
Description
Sample ID and specified time
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Description
Actual time pharmacokinetics
Type de données
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Description
Date sample
Type de données
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1302413
Description
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
C0244821 (UMLS CUI [1,2])
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C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
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C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
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C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
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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])