ID
25881
Description
Physical Examination, Laboratory, Parkinson's disease history - 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
Keywords
Versions (2)
- 9/24/17 9/24/17 -
- 9/24/17 9/24/17 -
Copyright Holder
glaxoSmithKline
Uploaded on
September 24, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Physical Examination, Laboratory, Parkinson's disease history - 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
Data type
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Description
Body system abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Description
Describe abnormality body system
Data type
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Description
Hematology Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0200627
Description
Hematology Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0200627
Description
Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0443354
Description
laboratory Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Unit laboratory result
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Clinical significant result
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Description
Serum Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0229671
Description
Serum laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0229671
Description
Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0443354
Description
laboratory Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Unit laboratory result
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Clinical significant result
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Description
Hepatitis screening
Alias
- UMLS CUI-1
- C1445958
Description
Date of sample
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0019158
Description
Hepatitis B surface antigen
Data type
integer
Alias
- UMLS CUI [1]
- C0019168
Description
Hepatitis C antibody
Data type
integer
Alias
- UMLS CUI [1]
- C0201487
Description
HIV screening
Alias
- UMLS CUI-1
- C0459958
Description
Date of sample
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0459958
Description
Human Immunodefiency Virus Antibody
Data type
integer
Alias
- UMLS CUI [1,1]
- C1321876
- UMLS CUI [1,2]
- C0201388
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Dip stick analysis
Alias
- UMLS CUI-1
- C1160927
Description
pH urine
Data type
float
Alias
- UMLS CUI [1]
- C0042044
Description
If positive for blood or protein, please perform microscopic analysis
Data type
text
Alias
- UMLS CUI [1]
- C0430371
Description
Urine glucose
Data type
text
Alias
- UMLS CUI [1]
- C0430376
Description
Urine bilirubin
Data type
text
Alias
- UMLS CUI [1]
- C0430374
Description
If positive for blood or protein, please perform microscopic analysis
Data type
text
Alias
- UMLS CUI [1]
- C0430372
Description
If positive for blood or protein, please perform microscopic analysis
Data type
boolean
Alias
- UMLS CUI [1]
- C0430397
Description
Microscopic analysis
Alias
- UMLS CUI-1
- C0430397
Description
erythrocytes urine
Data type
integer
Measurement units
- cells per field
Alias
- UMLS CUI [1]
- C2188659
Description
Leukocytes urine
Data type
integer
Measurement units
- cells per field
Alias
- UMLS CUI [1]
- C1254740
Description
Bacteria urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C1262012
- UMLS CUI [1,2]
- C0004618
Description
epithelia urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C3828199
- UMLS CUI [1,2]
- C1273342
Description
salts urine
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0036140
Description
Urine cast
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0151990
Description
Microscopic urinalysis other
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0205394
Description
Overall urinalysis assessment
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1274040
Description
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Description
Date of alcohol test
Data type
date
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0011008
Description
Time of alcohol test
Data type
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Description
Result of alcohol test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Description
alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Description
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Description
Date of drug screening
Data type
date
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0011008
Description
Time of drug screening
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Description
Cannabinoids urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Description
Morphine and morphine derivates urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Description
Amphetamine urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Description
Barbiturates urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Description
Benzodiazepines urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Description
Cocaine urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Description
Tricyclic antidepressants urine
Data type
integer
Alias
- UMLS CUI [1]
- C0003290
Description
Urine drug screening positive specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Description
Smoking history
Alias
- UMLS CUI-1
- C1519384
Description
Smoker
Data type
text
Alias
- UMLS CUI [1]
- C0543414
Description
cigarettes per day
Data type
integer
Alias
- UMLS CUI [1]
- C3694146
Description
cigars per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0678446
- UMLS CUI [1,2]
- C0439505
Description
pipes per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0337665
- UMLS CUI [1,2]
- C0439505
Description
Epworth sleep scale (ESS)
Alias
- UMLS CUI-1
- C3541276
Description
Hoehn and Yahr stage
Alias
- UMLS CUI-1
- C3639483
Description
Prior medications for treatment of Parkinson's disease
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C0030567
Description
Use generic name
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Description
Medication date started
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Medication date stopped
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
e.g. 10mg tid
Data type
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C3476109
Description
Route of drug administration
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Specify other route
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0013153
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Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
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