ID

35622

Beschreibung

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Stichworte

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  1. 12.03.19 12.03.19 -
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GSK group of companies

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12. März 2019

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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611

Englisch

Repeating Logs Pt 2

1 Formulare  
  1. StudyEvent: ODM
    1. Repeating Logs Pt 2
Administrative data
Beschreibung

Administrative data

Date of Visit
Beschreibung

Visit Date

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

12-lead ECG Abnormalities
Beschreibung

12-lead ECG Abnormalities

Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Rhythm Abnormalities
Beschreibung

Record clinically significant abnormalities below. Check all that apply:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0430456
P-Wave and QRS Morphology
Beschreibung

P-Wave and QRS Morphology

Datentyp

text

Conduction
Beschreibung

12 lead ECG, Abnormality, Cardiac conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Myocardial Infraction
Beschreibung

Myocardial Infraction

Datentyp

text

Depolarisation/Repolarisation (QRS-T)
Beschreibung

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other clinically significant abnormalities
Beschreibung

Other clinically significant abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Laboratory Report
Beschreibung

Laboratory Report

Date and Time Sample Taken
Beschreibung

Date and Time Sample Taken

Datentyp

datetime

Has the subject fasted?
Beschreibung

Subject fasted

Datentyp

boolean

Lab ID
Beschreibung

for internal use only

Datentyp

text

Clinical Chemistry
Beschreibung

Clinical Chemistry

Clinical Chemistry Test
Beschreibung

Clinical Chemistry Test

Datentyp

integer

Laboratory Test Result
Beschreibung

Laboratory Test Result

Datentyp

text

Hematology Test
Beschreibung

Hematology Test

Laboratory Test Result
Beschreibung

Laboratory Test Result

Datentyp

text

Hematology test
Beschreibung

Hematology test

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0332307
Vital Signs
Beschreibung

Vital Signs

Actual Date and Time
Beschreibung

Date and Time

Datentyp

datetime

Blood Pressure - Systolic
Beschreibung

Blood Pressure - Systolic

Datentyp

float

Maßeinheiten
  • mmHg
mmHg
Blood Pressure - Diastolic
Beschreibung

Blood Pressure - Diastolic

Datentyp

float

Maßeinheiten
  • mmHg
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Temperature
Beschreibung

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
°C
Peak Nasal Inspiratory Flow Rate
Beschreibung

Peak Nasal Inspiratory Flow Rate

Time of test
Beschreibung

Challenge time

Datentyp

integer

PNIF (reading 1)
Beschreibung

PNIF (reading 1)

Datentyp

integer

PNIF (reading 2)
Beschreibung

PNIF (reading 2)

Datentyp

integer

PNIF (reading 3)
Beschreibung

PNIF (reading 3)

Datentyp

integer

Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Actual Time
Beschreibung

Actual Time

Datentyp

time

Date Pharmacokinetics blood sample taken
Beschreibung

If sample is missed or lost, write "NA" in the Date Sample Taken column.

Datentyp

date

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1302413
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Ähnliche Modelle

Repeating Logs Pt 2

1 Formulare
  1. StudyEvent: ODM
    1. Repeating Logs Pt 2
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
12-lead ECG Abnormalities
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
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)
Item
P-Wave and QRS Morphology
text
P-Wave and QRS Morphology
Code List
P-Wave and QRS Morphology
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia  (14)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A33] Sinus arrhythmia  (15)
CL Item
[A27] Ventricular tachycardia  (16)
CL Item
[A30] Monomorphic ventricular tachycardia  (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker  (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm  (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
Conduction
Code List
Conduction
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block  (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block  (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
[C 15] Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
[C 9] Left bundle branch block  (14)
CL Item
[C 17] Bifascicular block (15)
CL Item
[C 10] Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (16)
CL Item
[C 11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
[C 18] AV dissociation (18)
CL Item
[C 28] Prolonged QT 450-500 (19)
CL Item
[C 29] Prolonged QT >500 (20)
CL Item
[C 30] Prolonged QTc interval 450-500 (21)
CL Item
[C 31] Prolonged QTc interval >500 (22)
CL Item
[C 99] Other Conduction (23)
Item
Myocardial Infraction
text
Myocardial Infraction
Code List
Myocardial Infraction
CL Item
[D 1] Myocardial infraction, old (1)
CL Item
[D 2] Myocardial infraction, anterior (2)
CL Item
[D 3] Myocardial infraction, lateral (3)
CL Item
[D 4] Myocardial infraction, posterior (4)
CL Item
[D 5] Myocardial infraction, inferior (5)
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
Depolarisation/Repolarisation (QRS-T)
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
CL Item
[D15] T waves flat (10)
CL Item
[D16] T waves biphasic (11)
CL Item
[D18] Notched T waves (12)
CL Item
[D13] Low QRS voltage (13)
CL Item
[D17] T-wave flattening/inversion (14)
CL Item
[D22] Juvenile T-wave pattern, early repolarization (15)
CL Item
[D97] T-wave abnormality, not specified (16)
CL Item
[D99] Other depolarization/repolarization (17)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Laboratory Report
Date and Time Sample Taken
Item
Date and Time Sample Taken
datetime
Subject fasted
Item
Has the subject fasted?
boolean
Lab ID
Item
Lab ID
text
Item Group
Clinical Chemistry
Item
Clinical Chemistry Test
integer
Clinical Chemistry Test
Code List
Clinical Chemistry Test
CL Item
Albumin (1)
CL Item
Alkaline Phosphatase (2)
CL Item
ALT (3)
CL Item
AST (4)
CL Item
Chloride (5)
CL Item
Creatinine (6)
CL Item
GGT (7)
CL Item
Glucose (8)
CL Item
Sodium (9)
CL Item
Total Bilirubin (10)
CL Item
Total Protein (11)
CL Item
Uric Acid (12)
CL Item
BUN (13)
CL Item
Cholesterol (14)
CL Item
CO2 (15)
CL Item
Triglycerides (16)
CL Item
Lactate Dehydrogenase (17)
CL Item
Calcium (18)
CL Item
ACTH (19)
CL Item
Progesterone (20)
CL Item
Cortisol (21)
CL Item
Testosterone (22)
CL Item
SHBG (23)
Laboratory Test Result
Item
Laboratory Test Result
text
Item Group
Hematology Test
Laboratory Test Result
Item
Laboratory Test Result
text
Item
Hematology test
integer
C0018941 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Hematology test
Code List
Hematology test
CL Item
Hemoglobin (1)
CL Item
Hematocrit (PCV) (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Item Group
Vital Signs
Date and Time
Item
Actual Date and Time
datetime
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Temperature
Item
Temperature
float
Item Group
Peak Nasal Inspiratory Flow Rate
Item
Time of test
integer
Challenge time
Code List
Time of test
CL Item
15 min (1)
CL Item
35 min (2)
CL Item
55 min (3)
CL Item
75 min (4)
PNIF (reading 1)
Item
PNIF (reading 1)
integer
PNIF (reading 2)
Item
PNIF (reading 2)
integer
PNIF (reading 3)
Item
PNIF (reading 3)
integer
Item Group
Pharmacokinetics Blood
Actual Time
Item
Actual Time
time
Date Pharmacokinetics blood sample taken
Item
Date Pharmacokinetics blood sample taken
date
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
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