Information:
Fel:
ID
26890
Beskrivning
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: Unscheduled
Nyckelord
Versioner (1)
- 2017-10-27 2017-10-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Unscheduled 101468/199
Similar models
Unscheduled
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
C0244821 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Investigational Product
integer
C0244821 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Ropinirole (1)
Date of Dose
Item
Date of Dose of Ropinirole
date
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose of Ropinirole
time
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose of Ropinirole
float
C3174092 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,2])
Units
Item
Units of Ropinirole
text
C1519795 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,2])
Route
Item
Route of Administration of Ropinirole
text
C0013153 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
C0244821 (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)
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])
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])
Item
Rhythm Abnormalities
integer
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Rhythm Abnormalities
Item
Rhythm Abnormalities, if Other please specify
text
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Item
P-Wave and QRS Morphology Abnormalities
integer
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
P-Wave and QRS Morphology Abnormalities
Item
P-Wave and QRS Morphology Abnormalities, if Other please specify
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
Item
Conduction Abnormalities
integer
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Conduction Abnormalities
Item
Conduction Abnormalities, if Other please specify
text
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non-Q wave (7)
CL Item
Other myocardial infarction (8)
Myocardial Infarction
Item
Myocardial Infarction, if Other please specify
text
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities
integer
C0948857 (UMLS CUI [1])
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
Repolarisation Abnormalities
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities, if Other please specify
text
C0948857 (UMLS CUI [1])
Other ECG Abnormalities
Item
Other ECG Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Other ECG Abnormalities
Item
Other ECG Abnormalities, please specify
text
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
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])