Informationen:
Fehler:
ID
26882
Beschreibung
Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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 Documentation part (Visit Description): Follow-up
Stichworte
Versionen (1)
- 27.10.17 27.10.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Follow-up 101468/199
Ähnliche Modelle
Follow-up
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date sample taken
Item
Date sample taken for Pregnancy test
boolean
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test Result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (P)
CL Item
Negative (N)
CL Item
Not applicable (Not of childbearing potential) (NA)
physical examination
Item
Has a physical examination been performed on the subject?
boolean
C0031809 (UMLS CUI [1])
physical examination finding
Item
Was the physical examination normal?
boolean
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Physical examination abnormal
Item
If Abnormal record below:
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Date Vital signs
Item
Date of Examination of Vital signs
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Planned Relative Time Vital signs
Item
Planned Relative Time of Examination of Vital signs
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Standing (2)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Laboratory Result Data Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
haemoglobin
Item
haemoglobin
float
C0518015 (UMLS CUI [1])
haematocrit
Item
haematocrit
float
C0018935 (UMLS CUI [1])
red blood cell
Item
red blood cell count
float
C0014772 (UMLS CUI [1])
WBC
Item
WBC (White Blood Cell count)
float
C0023508 (UMLS CUI [1])
platelet count
Item
platelet count
float
C0005821 (UMLS CUI [1])
Differential WBC count
Item
Differential WBC count
float
C0162401 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration (MCHC)
Item
Mean cell haemoglobin concentration (MCHC)
float
C0474535 (UMLS CUI [1])
Item Group
Laboratory Result Data Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Albumin/globulin ratio
Item
Albumin/globulin ratio
float
C0201837 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline phosphatase (AP)
Item
Alkaline phosphatase (AP)
float
C0201850 (UMLS CUI [1])
Gamma glutamyl transferase (GGT)
Item
Gamma glutamyl transferase (GGT)
float
C0202035 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatine phosphokinase
Item
Creatine phosphokinase
float
C0201973 (UMLS CUI [1])
Iron
Item
Iron
float
C0337439 (UMLS CUI [1])
Total Iron Binding Capacity
Item
Total Iron Binding Capacity
float
C1283048 (UMLS CUI [1])
Ferritin
Item
Ferritin
float
C0015879 (UMLS CUI [1])
Transferrin
Item
Transferrin
float
C0202105 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
FSH/LH
Item
FSH/LH
float
C2122182 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Item Group
Urinalysis, Dipstick Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Urine sample date
Item
Urine sample date
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Urine sample time
Item
Urine sample time
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Result of dipstick
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive. If positive, record results of individual tests below. (2)
CL Item
No Result (3)
Item
Urine Dipstick: Proteins
integer
C0428541 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Glucose
integer
C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Bilirubin
integer
C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Blood
integer
C0430372 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Specific gravity
integer
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0430370 (UMLS CUI [1,2])
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
casts
Item
Urinalysis (Microscopy) Test: Casts
text
C4048266 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,2])
Cells
Item
Urinalysis (Microscopy) Test: Cells
text
C0919738 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI-2)
treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,2])
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken, check one:
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Reason blind broken
Item
Reason blind broken: if Other, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Item Group
Investigational Product Discontinuation - Ropinirole
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
C0244821 (UMLS CUI-3)
C0457454 (UMLS CUI-2)
C0244821 (UMLS CUI-3)
Investigational product stopped
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
Item
If Yes, check the primary reason the investigational product was stopped
integer
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Code List
If Yes, check the primary reason the investigational product was stopped
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Other (7)
reason the investigational product was stopped
Item
If Other, specify the primary reason the investigational product was stopped
text
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
CL Item
Intramuscular (1)
(Comment:en)
CL Item
Inhalation (2)
(Comment:en)
CL Item
Intravenous (3)
(Comment:en)
CL Item
Nasal (4)
(Comment:en)
CL Item
Topical (5)
(Comment:en)
CL Item
Oral (6)
(Comment:en)
CL Item
Vaginal (7)
(Comment:en)
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Stop time
Item
Stop time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])