Information:
Fel:
ID
37668
Beskrivning
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy
Nyckelord
Versioner (2)
- 2019-08-14 2019-08-14 -
- 2019-08-14 2019-08-14 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
14 augusti 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)
Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood
Similar models
Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
12-Lead ECG - Dosing Date and Time
Item
12-Lead ECG - Dosing Date and Time
datetime
C0430456 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Date and Time of ECG (Pre-dose)
Item
Date and Time of ECG (Pre-dose)
datetime
C2826846 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI [2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 3(}-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate> 100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (wandering attial pacemaker w/rate > 100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate> 100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=I00 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
ldioventricular rhythm (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic venlricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial Pacemaker (A16)
CL Item
Other abnormal rhythm, enter comment (A99)
A. If other abnormal rhythm, enter comment
Item
A. If other abnormal rhythm, enter comment
text
C0232187 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
B. If other morphology, enter comment
Item
B. If other morphology, enter comment
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval > 200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
C. If other conduction, enter comment
Item
C. If other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
D. If other myocardial infarction, enter comment
Item
D. If other myocardial infarction, enter comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
C0948857 (UMLS CUI [2])
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattering/ inversion (D17)
CL Item
Other depolarisation/ repolarisation, enter comment (D99)
E. If other depolarisation/ repolarisation, enter comment
Item
E. If other depolarisation/ repolarisation, enter comment
text
C1395184 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
If other abnormalities, enter comment
Item
If other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Vital Signs - Dosing date/time
Item
Vital Signs - Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0518766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0518766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Vital Signs - Actual date/time (Pre-dose)
Item
Vital Signs - Actual date/time (Pre-dose)
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0439565 (UMLS CUI [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])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Investigational product - Date/time of dose
Item
Investigational product - Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI-2)
Did the subject receive the correct treatment
Item
Did the subject receive the correct treatment ( e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
If subject did not receive the correct treatment, record reason
Item
If subject did not receive the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Item
Clinical Chemistry same as the Haematology sample
integer
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
Code List
Clinical Chemistry same as the Haematology sample
CL Item
Same as the Haematology sample (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis sample not taken.
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Item Group
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Pharmacokinetics Blood Pre-36h (Lamotrigine)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Code List
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
CL Item
Pre-Dose (1)
CL Item
0.5h (2)
CL Item
1h (3)
CL Item
2h (4)
CL Item
3h (5)
CL Item
4h (6)
CL Item
6h (7)
CL Item
8h (8)
CL Item
10h (9)
CL Item
12h (10)
CL Item
13h (11)
CL Item
14h (12)
CL Item
15h (13)
CL Item
16h (14)
CL Item
18h (15)
CL Item
20h (16)
CL Item
22h (17)
CL Item
24h (18)
CL Item
26h (19)
CL Item
36h (20)
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
Item Group
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Pharmacokinetics Blood 48h - 144h (Lamotrigine)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Code List
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
CL Item
48h (1)
CL Item
72h (2)
CL Item
96h (3)
CL Item
120h (4)
CL Item
144h (5)
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])