Information:
Fel:
ID
25881
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-09-24 2017-09-24 -
- 2017-09-24 2017-09-24 -
Rättsinnehavare
glaxoSmithKline
Uppladdad den
24 september 2017
DOI
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Licens
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
Similar models
Physical Examination, Laboratory, Parkinson's disease history - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Height
Item
Height
float
C0005890 (UMLS CUI [1])
CL Item
in (1)
CL Item
cm (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
CL Item
lb (1)
CL Item
kg (2)
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Hematopoietic and lymphatic (9)
CL Item
Endocrine and metabolic (10)
CL Item
other (11)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done/ not applicable (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
C0200627 (UMLS CUI-2)
Serum Laboratory evaluation
Item
Serum Laboratory not done
boolean
C0022885 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
C0200627 (UMLS CUI-2)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Item Group
Serum Laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
C0229671 (UMLS CUI-2)
Serum Laboratory evaluation
Item
Serum Laboratory not done
boolean
C0022885 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Serum laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
C0229671 (UMLS CUI-2)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0019158 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0019158 (UMLS CUI [1,3])
Item
Hepatitis B surface antigen (HBsAG)
integer
C0019168 (UMLS CUI [1])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Date of sample
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0459958 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0459958 (UMLS CUI [1,3])
Item
Result of Human Immunodefiency Virus Antibody (ELISA)
integer
C1321876 (UMLS CUI [1,1])
C0201388 (UMLS CUI [1,2])
C0201388 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
Date of urinalysis
Item
Date of examination
date
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of urinalysis
Item
Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
pH urine
Item
pH value
float
C0042044 (UMLS CUI [1])
CL Item
neg (neg)
CL Item
pos (pos)
CL Item
neg (neg)
CL Item
pos (pos)
CL Item
neg (neg)
CL Item
pos (pos)
CL Item
neg (neg)
CL Item
pos (pos)
urine microscopic analysis
Item
microscopic analysis
boolean
C0430397 (UMLS CUI [1])
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
CL Item
none (1)
CL Item
few (2)
CL Item
moderate (3)
CL Item
abundant (4)
CL Item
none (1)
CL Item
squamous (2)
CL Item
round (3)
CL Item
other (4)
salts urine
Item
Salts
text
C0430397 (UMLS CUI [1,1])
C0036140 (UMLS CUI [1,2])
C0036140 (UMLS CUI [1,2])
Urine cast
Item
Cast
text
C0430397 (UMLS CUI [1,1])
C0151990 (UMLS CUI [1,2])
C0151990 (UMLS CUI [1,2])
Microscopic urinalysis other
Item
Other
text
C0430397 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item Group
Overall urinalysis assessment
C0042014 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
Item
Overall urinalysis assessment
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Urinalysis abnormal specify
Item
If abnormal - clinically significant, describe
text
C0438142 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Date of alcohol test
Item
Date of examination
date
C0202304 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B. Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,2])
Date of drug screening
Item
Date of examination
date
C0202274 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
C0279996 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
CL Item
yes (1)
CL Item
no (2)
cigarettes per day
Item
Number of cigarettes per day.
integer
C3694146 (UMLS CUI [1])
cigars per day
Item
Number of cigars per day.
integer
C0678446 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
pipes per day
Item
Number of pipes per day.
integer
C0337665 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
Epworth sleep scale (ESS)
Item
Epworth sleep scale (ESS)
text
C3541276 (UMLS CUI [1])
Item
Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
text
C3639483 (UMLS CUI [1])
Code List
Indicate the patient's baseline Hoehn & Yahr Stage by ticking the appropriate box below:
CL Item
No signs of disease (Stage 0)
CL Item
Unilateral disease (Stage 1)
CL Item
Unilateral disease plus axial involvement (Stage 1.5)
CL Item
Mild bilateral disease, without impairment of balance (Stage 2)
CL Item
Mild bilateral disease, with recovery on pull test (Stage 2.5)
CL Item
Mild to moderate bilateral disease: some postural instability; physically independent (Stage 3)
CL Item
Severe disability: still able to walk or stand unassisted (Stage 4)
CL Item
Wheelchair bound or bedridden unless aided (Stage 5)
Item
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
integer
C1514989 (UMLS CUI [1])
Code List
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to screening
CL Item
yes (1)
CL Item
no (2)
Item Group
Prior medications for treatment of Parkinson's disease
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
C0030567 (UMLS CUI-2)
Generic name medication
Item
Medication
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
C0592502 (UMLS CUI [1,2])
Medication date started
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Medication date stopped
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Dose and frequency of medication
Item
Dose and frequency
text
C3174092 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,2])
CL Item
IV (1)
CL Item
PR (2)
CL Item
IM (3)
CL Item
Sublingual (4)
CL Item
PO (5)
CL Item
Inhaled (6)
CL Item
SC (7)
CL Item
Topical (8)
CL Item
other (9)
Specify other route
Item
Please, specify other route.
text
C1521902 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
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