ID

35636

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

  1. 13.03.19 13.03.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

13. März 2019

DOI

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

  1. StudyEvent: ODM
    1. Period 2
Administrative data
Beschreibung

Administrative data

Date of Visit
Beschreibung

Visit Date

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Investigational Product (Dose)
Beschreibung

Investigational Product (Dose)

Date and Time of Dose
Beschreibung

Dose Date and Time

Datentyp

datetime

Did the subject receive the correct treatment (e.g., treament which the subject was assigned to) during this dosing interval?
Beschreibung

Treatment Confirmation

Datentyp

boolean

Record reasons for incorrect treatment
Beschreibung

Incorrect Treatment Reasons

Datentyp

text

Vital Signs (Dosing)
Beschreibung

Vital Signs (Dosing)

Choose Dose Time
Beschreibung

Dose Time

Datentyp

integer

Blood Pressure - Systolic
Beschreibung

Blood Pressure - Systolic

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Blood Pressure - Diastolic
Beschreibung

Blood Pressure - Diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Temperature (Dosing)
Beschreibung

Temperature (Dosing)

Choose Dose Time
Beschreibung

Dose Time

Datentyp

integer

t° Reading1
Beschreibung

t° Reading1

Datentyp

float

Maßeinheiten
  • °C
°C
t° Reading2
Beschreibung

t° Reading2

Datentyp

float

Maßeinheiten
  • °C
°C
t° Reading3
Beschreibung

t° Reading3

Datentyp

float

Maßeinheiten
  • °C
°C
Hematology (Dosing)
Beschreibung

Hematology (Dosing)

Choose Dose Time
Beschreibung

Dose Time

Datentyp

integer

Has the subject fasted?
Beschreibung

Fasting

Datentyp

boolean

WBC
Beschreibung

WBC

Datentyp

text

Alias
UMLS CUI [1]
C0023508
RBC
Beschreibung

RBC

Datentyp

text

Alias
UMLS CUI [1]
C0014772
Haemoglobin
Beschreibung

Hemoglobin measurement

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Maßeinheiten
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

Monocytes

Datentyp

float

Maßeinheiten
  • 10^9/L
Alias
UMLS CUI [1]
C0026473
10^9/L
Eosinophils
Beschreibung

Eosinophils

Datentyp

float

Maßeinheiten
  • 10^9/L
Alias
UMLS CUI [1]
C0200638
10^9/L
Basophils
Beschreibung

Basophils

Datentyp

float

Maßeinheiten
  • 10^9/L
Alias
UMLS CUI [1]
C0200641
10^9/L
Platelets
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 10^9/ L
Alias
UMLS CUI [1]
C0005821
10^9/ L
Reticulocyte count
Beschreibung

Reticulocyte count

Datentyp

float

Alias
UMLS CUI [1]
C0206161
MCV
Beschreibung

MCV

Datentyp

integer

Maßeinheiten
  • fL
fL
MCH
Beschreibung

MCH

Datentyp

float

Maßeinheiten
  • pg
Alias
UMLS CUI [1]
C0369183
pg
MCHC
Beschreibung

Mean corpuscular hemoglobin concentration determination

Datentyp

float

Alias
UMLS CUI [1]
C0474535
Date of test
Beschreibung

Test Date

Datentyp

date

Clinical Chemistry
Beschreibung

Clinical Chemistry

Choose Dose Time
Beschreibung

Dose Time

Datentyp

text

Has the subject fasted?
Beschreibung

Fasting

Datentyp

boolean

ALT
Beschreibung

ALT

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST
Beschreibung

Chemistry, Clinical; Aspartate aminotransferase measurement

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201899
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0201913
Glucose
Beschreibung

Glucose

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
GGT
Beschreibung

Chemistry, Clinical; Gamma glutamyl transferase measurement

Datentyp

float

Alias
UMLS CUI [1]
C0202035
Total Protein
Beschreibung

Chemistry, Clinical; Total Protein measurement

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Potassium
Beschreibung

Potassium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Sodium
Beschreibung

Sodium

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Chloride
Beschreibung

Chloride

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
Creatinine
Beschreibung

Chemistry, Clinical, Creatinine measurement

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201975
Uric acid
Beschreibung

Chemistry, Clinical; Uric acid

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0041980
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
[BUN] BUN
Beschreibung

BUN

Datentyp

float

Maßeinheiten
  • mg/dL
mg/dL
Cholesterol
Beschreibung

Cholesterol

Datentyp

float

Alias
UMLS CUI [1]
C1445957
Total CO2 - Character result
Beschreibung

Carbon dioxide total measurement; Result; Data Type -Character

Datentyp

text

Alias
UMLS CUI [1,1]
C0860709
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C2350015
Triglycerides
Beschreibung

Triglycerides

Datentyp

float

Alias
UMLS CUI [1]
C0202236
Lactate Dehydrogenase (LDH)
Beschreibung

LDH

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Calcium
Beschreibung

Calcium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Plasma ACTH
Beschreibung

Plasma ACTH

Datentyp

text

Serum Progesterone
Beschreibung

Serum Progesterone

Datentyp

text

Serum cortisol
Beschreibung

Serum cortisol

Datentyp

text

Maßeinheiten
  • g/dL
g/dL
Serum testosterone
Beschreibung

Serum testosterone

Datentyp

text

SHBG
Beschreibung

SHBG

Datentyp

text

Maßeinheiten
  • nmol/l
Alias
UMLS CUI [1]
C0202218
nmol/l
Electrocardiogram
Beschreibung

Electrocardiogram

Choose Dose Time
Beschreibung

Dose Time

Datentyp

integer

Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Beschreibung

Electrocardiogram: P-R interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS complex duration (observable entity)

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beschreibung

QT interval - finding

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Beschreibung

qtc interval; Evaluation Method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Peak Nasal Inspiratory Flow Rate
Beschreibung

Peak Nasal Inspiratory Flow Rate

Choose Time of Test
Beschreibung

Test Time

Datentyp

text

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

Total Symptom Score
Beschreibung

Total Symptom Score

Choose the Dose Time
Beschreibung

Dose Time

Datentyp

integer

Nasal congestion score
Beschreibung

Nasal congestion score

Datentyp

integer

Rhinorrhoea score
Beschreibung

Rhinorrhoea score

Datentyp

integer

Lacrimation score
Beschreibung

Lacrimation score

Datentyp

integer

Burning/pain score
Beschreibung

Burning/pain score

Datentyp

integer

Total Symptom Score
Beschreibung

Total Symptom Score

Datentyp

text

Visual Analogue Scale
Beschreibung

Visual Analogue Scale

Choose Dose Time (assessment time)
Beschreibung

Dose Time

Datentyp

integer

Nasal congestion VAS score
Beschreibung

Nasal congestion VAS score

Datentyp

integer

Maßeinheiten
  • mm
mm
Rhinorrhoea VAS Score
Beschreibung

Rhinorrhoea VAS Score

Datentyp

text

Maßeinheiten
  • mm
mm
Lacrimation VAS score
Beschreibung

Lacrimation VAS score

Datentyp

integer

Maßeinheiten
  • mm
mm
Burning/pain VAS score
Beschreibung

Burning/pain VAS score

Datentyp

integer

Maßeinheiten
  • mm
mm
Nostril Secretions
Beschreibung

Nostril Secretions

Choose the Dose Time
Beschreibung

Dose Time

Datentyp

integer

Actual start time
Beschreibung

Actual start time

Datentyp

time

Actual end time
Beschreibung

Actual end time

Datentyp

time

Acciwik Left Nostril secretion weight
Beschreibung

Acciwik Left Nostril secretion weight

Datentyp

float

Maßeinheiten
  • mg
mg
Tissue Left Nostril secretion weight
Beschreibung

Tissue Left Nostril secretion weight

Datentyp

float

Maßeinheiten
  • mg
mg
Acciwik Right Nostril secretion weight
Beschreibung

Acciwik Right Nostril secretion weight

Datentyp

float

Maßeinheiten
  • mg
mg
Tissue Right Nostril secretion weight
Beschreibung

Tissue Right Nostril secretion weight

Datentyp

float

Maßeinheiten
  • mg
mg
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Choose the Dose Time
Beschreibung

Dose Time

Datentyp

integer

Actual time
Beschreibung

Actual time

Datentyp

time

Ähnliche Modelle

Period 2

  1. StudyEvent: ODM
    1. Period 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
Investigational Product (Dose)
Dose Date and Time
Item
Date and Time of Dose
datetime
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treament which the subject was assigned to) during this dosing interval?
boolean
Incorrect Treatment Reasons
Item
Record reasons for incorrect treatment
text
Item Group
Vital Signs (Dosing)
Item
Choose Dose Time
integer
Code List
Choose Dose Time
CL Item
Pre-Dose (1)
CL Item
20 min (2)
CL Item
40 min (3)
CL Item
60 min (4)
CL Item
80 min (5)
CL Item
100 min (6)
CL Item
120 min (7)
CL Item
3 hrs (8)
CL Item
4 hrs (9)
CL Item
5 hrs (10)
CL Item
6 hrs (11)
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
integer
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Temperature (Dosing)
Item
Choose Dose Time
integer
Code List
Choose Dose Time
CL Item
Pre-Dose (1)
CL Item
20 min (2)
CL Item
40 min (3)
CL Item
60 min (4)
CL Item
80 min (5)
CL Item
100 min (6)
CL Item
120 min (7)
CL Item
3 hrs (8)
CL Item
4 hrs (9)
CL Item
5 hrs (10)
CL Item
6 hrs (11)
t° Reading1
Item
t° Reading1
float
t° Reading2
Item
t° Reading2
float
t° Reading3
Item
t° Reading3
float
Item Group
Hematology (Dosing)
Item
Choose Dose Time
integer
Code List
Choose Dose Time
CL Item
Pre-Dose (1)
CL Item
6 hrs (2)
Fasting
Item
Has the subject fasted?
boolean
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
RBC
Item
RBC
text
C0014772 (UMLS CUI [1])
Hemoglobin measurement
Item
Haemoglobin
float
C0518015 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
text
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Reticulocyte count
Item
Reticulocyte count
float
C0206161 (UMLS CUI [1])
MCV
Item
MCV
integer
MCH
Item
MCH
float
C0369183 (UMLS CUI [1])
Mean corpuscular hemoglobin concentration determination
Item
MCHC
float
C0474535 (UMLS CUI [1])
Test Date
Item
Date of test
date
Item Group
Clinical Chemistry
Item
Choose Dose Time
text
Code List
Choose Dose Time
CL Item
Pre-Dose (1)
CL Item
6 hrs (2)
Fasting
Item
Has the subject fasted?
boolean
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Chemistry, Clinical; Aspartate aminotransferase measurement
Item
AST
float
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Chemistry, Clinical; Gamma glutamyl transferase measurement
Item
GGT
float
C0202035 (UMLS CUI [1])
Chemistry, Clinical; Total Protein measurement
Item
Total Protein
float
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Chemistry, Clinical, Creatinine measurement
Item
Creatinine
float
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Chemistry, Clinical; Uric acid
Item
Uric acid
float
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
BUN
Item
[BUN] BUN
float
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Carbon dioxide total measurement; Result; Data Type -Character
Item
Total CO2 - Character result
text
C0860709 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase (LDH)
float
C0202113 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Plasma ACTH
Item
Plasma ACTH
text
Item
Serum Progesterone
text
Code List
Serum Progesterone
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Serum cortisol
Item
text
Serum testosterone
Item
Serum testosterone
text
SHBG
Item
text
C0202218 (UMLS CUI [1])
Item Group
Electrocardiogram
Item
Choose Dose Time
integer
Code List
Choose Dose Time
CL Item
Pre-Dose (1)
CL Item
60 min (2)
CL Item
120 min (3)
CL Item
3 hrs (4)
CL Item
4 hrs (5)
CL Item
5 hrs (6)
CL Item
6 hrs (7)
Time of ECG
Item
Time of ECG
time
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0489625 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
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)
Item Group
Peak Nasal Inspiratory Flow Rate
Item
Choose Time of Test
text
Code List
Choose Time of Test
CL Item
55 min (1)
CL Item
75 min (2)
CL Item
95 min (3)
CL Item
115 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
Total Symptom Score
Item
Choose the Dose Time
integer
Code List
Choose the Dose Time
CL Item
41 min (1)
CL Item
45 min (2)
CL Item
50 min (3)
CL Item
61 min (4)
CL Item
65 min (5)
CL Item
70 min (6)
CL Item
81 min (7)
CL Item
85 min (8)
CL Item
90 min (9)
CL Item
101 min (10)
CL Item
105 min (11)
CL Item
110 min (12)
Nasal congestion score
Item
Nasal congestion score
integer
Rhinorrhoea score
Item
Rhinorrhoea score
integer
Lacrimation score
Item
Lacrimation score
integer
Burning/pain score
Item
Burning/pain score
integer
Total Symptom Score
Item
Total Symptom Score
text
Item Group
Visual Analogue Scale
Item
Choose Dose Time (assessment time)
integer
Code List
Choose Dose Time (assessment time)
CL Item
41 min (1)
CL Item
45 min (2)
CL Item
50 min (3)
CL Item
61 min (4)
CL Item
65 min (5)
CL Item
70 min (6)
CL Item
81 min (7)
CL Item
85 min (8)
CL Item
90 min (9)
CL Item
101 min (10)
CL Item
105 min (11)
CL Item
110 min (12)
Nasal congestion VAS score
Item
Nasal congestion VAS score
integer
Rhinorrhoea VAS Score
Item
Rhinorrhoea VAS Score
text
Lacrimation VAS score
Item
Lacrimation VAS score
integer
Burning/pain VAS score
Item
Burning/pain VAS score
integer
Item Group
Nostril Secretions
Item
Choose the Dose Time
integer
Code List
Choose the Dose Time
CL Item
41-43 min (1)
CL Item
45-47 min (2)
CL Item
49-51 min (3)
CL Item
61-63 min (5)
CL Item
65-67 min (6)
CL Item
69-71 min (7)
CL Item
81-83 min (8)
CL Item
85-87 min (9)
CL Item
89-91 min (10)
CL Item
101-103 min (11)
CL Item
105-107 min (12)
CL Item
109-111 min (13)
Actual start time
Item
Actual start time
time
Actual end time
Item
Actual end time
time
Acciwik Left Nostril secretion weight
Item
Acciwik Left Nostril secretion weight
float
Tissue Left Nostril secretion weight
Item
Tissue Left Nostril secretion weight
float
Acciwik Right Nostril secretion weight
Item
Acciwik Right Nostril secretion weight
float
Tissue Right Nostril secretion weight
Item
Tissue Right Nostril secretion weight
float
Item Group
Pharmacokinetics - Blood
Item
Choose the Dose Time
integer
Code List
Choose the Dose Time
CL Item
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time

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