ID

39587

Descrição

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Palavras-chave

Versões (2)
  1. 26/01/2020 26/01/2020 -
  2. 01/02/2020 01/02/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

1 de fevereiro de 2020

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

Inglês

V3

1 Formulários  
  1. StudyEvent: ODM
    1. V3
Date of Visit
Descrição

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Descrição

Date of visit, Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
2D6 Status
Descrição

2D6 Status

Alias
UMLS CUI-1
C2962190
UMLS CUI-2
C0449438
Date and time sample taken
Descrição

Cytochrome P450 2D6 Inhibitors [MoA], Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C2962190
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
2D6 Status
Descrição

Cytochrome P450 2D6 Inhibitors [MoA], Status

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2962190
UMLS CUI [1,2]
C0449438
ABPM
Descrição

ABPM

Alias
UMLS CUI-1
C0242876
Start date/time ambulatory blood pressure
Descrição

Blood Pressure Monitoring, Ambulatory, Start Date, Start time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
End date/time ambulatory blood pressure
Descrição

Blood Pressure Monitoring, Ambulatory, End date, End Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
CogState
Descrição

CogState

Alias
UMLS CUI-1
C0392335
UMLS CUI-2
C0392366
Test 1 - Date and time test taken
Descrição

Cognitive functions, Tests, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test 1 - Not done
Descrição

Cognitive functions, Tests, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C1272696
Test 2 - Date and time test taken
Descrição

Cognitive functions, Tests, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test 2 - Not done
Descrição

Cognitive functions, Tests, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C1272696
D-1 - Date and time test taken
Descrição

Cognitive functions, Tests, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
D-1 - Not done
Descrição

Cognitive functions, Tests, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C1272696
Holter
Descrição

Holter

Alias
UMLS CUI-1
C0013801
Start Date and Time of Holter
Descrição

Holter Electrocardiography, Start Date, Start time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Stop Date and Time of Holter
Descrição

Holter Electrocardiography, End date, End Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Interpretation of Holter
Descrição

Holter Electrocardiography, Clinical Interpretation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Summary Holter Abnormalities
Descrição

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Record clinically significant abnormalities below - Check all that apply
Descrição

Holter Electrocardiography, Abnormality

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Electronically Transferred Lab Data
Descrição

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Descrição

Hematology finding, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Hematology finding, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Chemistry, Clinical, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descrição

Urinalysis, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Urinalysis, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
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Similar models

V3

1 Formulários
  1. StudyEvent: ODM
    1. V3
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
2D6 Status
C2962190 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Cytochrome P450 2D6 Inhibitors [MoA], Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C2962190 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
2D6 Status
text
C2962190 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Gender
Code List
2D6 Status
CL Item
Extensive metabolizer (1)
CL Item
Poor metabolizer (2)
Item Group
ABPM
C0242876 (UMLS CUI-1)
Blood Pressure Monitoring, Ambulatory, Start Date, Start time
Item
Start date/time ambulatory blood pressure
datetime
C0242876 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Blood Pressure Monitoring, Ambulatory, End date, End Time
Item
End date/time ambulatory blood pressure
datetime
C0242876 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
CogState
C0392335 (UMLS CUI-1)
C0392366 (UMLS CUI-2)
Cognitive functions, Tests, Date in time, Time
Item
Test 1 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Cognitive functions, Tests, Not Done
Item
Test 1 - Not done
boolean
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Cognitive functions, Tests, Date in time, Time
Item
Test 2 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Cognitive functions, Tests, Not Done
Item
Test 2 - Not done
boolean
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Cognitive functions, Tests, Date in time, Time
Item
D-1 - Date and time test taken
datetime
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Cognitive functions, Tests, Not Done
Item
D-1 - Not done
boolean
C0392335 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Holter
C0013801 (UMLS CUI-1)
Holter Electrocardiography, Start Date, Start time
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Holter Electrocardiography, End date, End Time
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Holter Electrocardiography, Clinical Interpretation
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Record clinically significant abnormalities below - Check all that apply
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
undefined item
Code List
Record clinically significant abnormalities below - Check all that apply
CL Item
No abnormalities (1)
CL Item
Sinus bradycardia (50-59 beats/min) (2)
CL Item
Sinus bradycardia (40-49 beats/min) (3)
CL Item
Sinus bradycardia (30-39 beats/min) (4)
CL Item
Sinus bradycardia (<30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (>100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
CL Item
Atrial flutter (14)
CL Item
Atrial fibrillation (15)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
CL Item
Junctional tachycardia (>100 beats/min) (17)
CL Item
Ventricular premature deplorisation (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
CL Item
Wide QRS tachycardia (diagnosis unknown (28)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
CL Item
Torsades de Pointes (TdP) (33)
CL Item
Pacemaker (34)
CL Item
First degree AV block (PR interval >200msec) (35)
CL Item
Short PR Intervak (36)
CL Item
Second degree AV block (Mobitz type 1) (37)
CL Item
Second degree AV block (Mobitz type 2) (38)
CL Item
2:1 AV block (39)
CL Item
Third degree AV block (40)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (41)
CL Item
Right axis deviation (QRS axis more positive than +100 degrees) (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Incomplete left bundle branch block (44)
CL Item
Right bundle branch block (45)
CL Item
Left anterior hemiblock (46)
CL Item
Left posterior hemiblock (47)
CL Item
Left bundle branch block (48)
CL Item
Bifascicular block (49)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
CL Item
QTc prolongation >=500 msec (52)
CL Item
AV dissociation (53)
CL Item
Myocardial infarction, old (54)
CL Item
Myocardial infarction, non Q-wave (55)
CL Item
Non-specific ST-T changes (56)
CL Item
J point elevation (57)
CL Item
ST elevation (58)
CL Item
ST depression (59)
CL Item
ST segment abnormality (60)
CL Item
U waves (61)
CL Item
T wave inversion (62)
CL Item
T wave peaked (63)
CL Item
T waves biphasic (64)
CL Item
T waves flat (65)
CL Item
66)Notched T-waves (66)Notched T-waves)
CL Item
Low QRS voltage (67)
CL Item
T wave abnormality (68)
CL Item
Other abnormal rhythm (69)
CL Item
Other morphology (70)
CL Item
Other conduction (71)
CL Item
Other myocardial infarction (72)
CL Item
Other depolarization/repolarisation (73)
CL Item
Other abnormality/Cardiologist comments (74)
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Hematology finding, Sampling, Date in time, Time
Item
Haematology Date and time sample taken
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hematology finding, Sampling, Not Done
Item
Not Done
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Date in time, Time
Code List
Clinical Chemistry Date and time sample taken
CL Item
Same as the Haematology sample (1)
Chemistry, Clinical, Sampling, Date in time, Time
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Not Done
Item
Not Done
boolean
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis, Sampling, Date in time, Time
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis, Sampling, Not Done
Item
Not Done
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
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