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ID
26188
Beschreibung
Follow-up - 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
Stichworte
Versionen (1)
- 10/10/2017 10/10/2017 -
Rechteinhaber
glaxoSmithKline
Hochgeladen am
10 octobre 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Ähnliche Modelle
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject experienced any Adverse Events since the previous clinic visit?
integer
C0877248 (UMLS CUI [1])
Code List
Has the subject experienced any Adverse Events since the previous clinic visit?
CL Item
Yes (1)
CL Item
No (2)
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary.
text
C3890583 (UMLS CUI [1])
time of ECG
Item
Actual time of ECG reading
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
heart rate
Item
heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
P-R interval
Item
P-R interval
float
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
float
C0520880 (UMLS CUI [1])
QTc interval
Item
QTc interval
float
C0855331 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Specify ECG abnormality
Item
If abnormal - clinically significant, describe
text
C0522055 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Item Group
orthostatic blood pressure / Pulse
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
CL Item
Serum (1)
CL Item
Urine (2)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
positive (1)
CL Item
negative (2)
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
other (9)
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])
strenuous activity
Item
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to the Follow-up Visit.
boolean
C1514989 (UMLS CUI [1])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
C0200627 (UMLS CUI-2)
Hematology laboratory evaluation
Item
Hematology not done
boolean
C0022885 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C0200627 (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 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])
Item
Did the subject complete the Part A of the study?
integer
C2348577 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
Item
If NO, check the one most significant reason below
integer
C1709849 (UMLS CUI [1])
CL Item
Adverse event (if reason for discontinuation is adverse event, record the event on the Adverse Events page.) (1)
CL Item
Subject request (unrelated to AE) (2)
CL Item
Non-complicance (unrelated to AE) (3)
CL Item
Investigator judgement (4)
CL Item
Termination of subject dosing by sponsor (5)
CL Item
Protocol violation (6)
CL Item
Death; complete the Subject Death CRF (7)
CL Item
Other (8)
Specify subjects request for study discontinuation
Item
Specify subjects request for study discontinuation
text
C0332153 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify non-compliance
Item
Specify non-compliance
text
C0457432 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify investigator's judgement
Item
Specify investigator's judgement
text
C0008961 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for study discontinuation
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Did the subject complete the Part B of the study?
integer
C2348577 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
Item
If NO, check the one most significant reason below
integer
C1709849 (UMLS CUI [1])
CL Item
Adverse event (if reason for discontinuation is adverse event, record the event on the Adverse Events page.) (1)
CL Item
Subject request (unrelated to AE) (2)
CL Item
Non-complicance (unrelated to AE) (3)
CL Item
Investigator judgement (4)
CL Item
Termination of subject dosing by sponsor (5)
CL Item
Protocol violation (6)
CL Item
Death; complete the Subject Death CRF (7)
CL Item
Other (8)
Specify subjects request for study discontinuation
Item
Specify subjects request for study discontinuation
text
C0332153 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify non-compliance
Item
Specify non-compliance
text
C0457432 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify investigator's judgement
Item
Specify investigator's judgement
text
C0008961 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for study discontinuation
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Investigator signature
Item
To be completed by the Principal Investigator: I have assumed responsibility for completeness and accuracy of all data recorded on these Case Report Forms
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Print name
text
C2826892 (UMLS CUI [1])
Date of investigator signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])