ID

26890

Description

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

Mots-clés

Drug trial

Laboratories

Klinische Studie [Dokumenttyp]

Electrocardiogram (ECG)

G25.81

27/10/2017 27/10/2017 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

27 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Pharmacokinetics of a new unmarketed formulation of ropinirole Unscheduled 101468/199

model
Détails

Unscheduled

1 Formulaires

StudyEvent: ODM
1. Unscheduled

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Investigational Product

Item Group

Investigational Product

C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)

Subject Identifier

Item

Subject Identifier

integer

C2348585 (UMLS CUI [1])

Investigational Product

Item

Investigational Product

integer

C0244821 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])

Investigational Product

Code List

Investigational Product

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])

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])

Dose

Item

Dose of Ropinirole

float

C3174092 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])

Units

Item

Units of Ropinirole

text

C1519795 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])

Route

Item

Route of Administration of Ropinirole

text

C0013153 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])

12-lead ECG

Item Group

12-lead ECG

C0430456 (UMLS CUI-1)
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])

Planned Relative Time ECG

Item

Planned Relative Time ECG

text

C0430456 (UMLS CUI [1,1])
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])

Ventricular Rate

Item

Ventricular Rate

integer

C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

PR Interval

Item

PR Interval

float

C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

QRS Duration

Item

QRS Duration

float

C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

Uncorrected QT Interval

Item

Uncorrected QT Interval

float

C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

QTc Interval

Item

QTc Interval

float

C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

Result of the ECG

Item

Result of the ECG

integer

C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

Result of the ECG

Code List

Result of the ECG

CL Item

Normal (1)

CL Item

Abnormal - not clinically significant (2)

CL Item

Abnormal- clinically significant (3)

CL Item

No result (not available) (4)

ECG Abnormalities

Item Group

ECG Abnormalities

C0522055 (UMLS CUI-1)
C0430456 (UMLS CUI-2)

Start Date of ECG

Item

Start Date of ECG

date

C0430456 (UMLS CUI [1,1])
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])

Rhythm Abnormalities

Item

Rhythm Abnormalities

integer

C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])

Rhythm Abnormalities

Code List

Rhythm Abnormalities

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])

P-Wave and QRS Morphology Abnormalities

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])

P-Wave and QRS Morphology Abnormalities

Code List

P-Wave and QRS Morphology Abnormalities

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])

Conduction Abnormalities

Item

Conduction Abnormalities

integer

C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])

Conduction Abnormalities

Code List

Conduction Abnormalities

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])

Myocardial Infarction

Item

Myocardial Infarction

integer

C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])

Myocardial Infarction

Code List

Myocardial Infarction

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])

Repolarisation Abnormalities

Item

Depolarisation/Repolarisation (QRS-T) Abnormalities

integer

C0948857 (UMLS CUI [1])

Repolarisation Abnormalities

Code List

Depolarisation/Repolarisation (QRS-T) Abnormalities

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])

Other ECG Abnormalities

Item

Other ECG Abnormalities, please specify

text

C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])

Laboratory Result Data Haematology

Item Group

Laboratory Result Data Haematology

C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)

Date sample taken

Item

Date sample taken

date

C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time sample taken

Item

Time sample taken

time

C0005834 (UMLS CUI [1,1])
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])

Laboratory Result Data Clinical Chemistry

Item Group

Laboratory Result Data Clinical Chemistry

C0008000 (UMLS CUI-1)
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])

Time sample taken

Item

Time sample taken

time

C0005834 (UMLS CUI [1,1])
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])

Urinalysis, Dipstick Test

Item Group

Urinalysis, Dipstick Test

C0042014 (UMLS CUI-1)
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])

Urine sample time

Item

Urine sample time

time

C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

Result of dipstick

Item

Result of dipstick

integer

C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])

Result of dipstick

Code List

Result of dipstick

CL Item

Negative (1)

CL Item

Positive. If positive, record results of individual tests below. (2)

CL Item

No Result (3)

Urine Dipstick: Proteins

Item

Urine Dipstick: Proteins

integer

C0428541 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: Proteins

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)

Urine Dipstick: Glucose

Item

Urine Dipstick: Glucose

integer

C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: Glucose

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)

Urine Dipstick: pH

Item

Urine Dipstick: pH

integer

C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: pH

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)

Urine Dipstick: Bilirubin

Item

Urine Dipstick: Bilirubin

integer

C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: Bilirubin

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)

Urine Dipstick: Blood

Item

Urine Dipstick: Blood

integer

C0430372 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: Blood

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)

Urine Dipstick: Specific gravity

Item

Urine Dipstick: Specific gravity

integer

C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urine Dipstick Proteins

Code List

Urine Dipstick: Specific gravity

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])

casts

Item

Urinalysis (Microscopy) Test: Casts

text

C4048266 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])

Cells

Item

Urinalysis (Microscopy) Test: Cells

text

C0919738 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])

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ID

Description

Mots-clés

Versions (1)

Détendeur de droits

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Pharmacokinetics of a new unmarketed formulation of ropinirole Unscheduled 101468/199

Unscheduled

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description