ID

35635

Description

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

Keywords

  1. 3/13/19 3/13/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 13, 2019

DOI

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License

Creative Commons BY-NC 3.0

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

Period 1

  1. StudyEvent: ODM
    1. Period 1
Administrative data
Description

Administrative data

Date of Visit
Description

Visit Date

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Vital Signs Pre-Challenge
Description

Vital Signs Pre-Challenge

Actual Date and Time
Description

Actual Date / Time

Data type

datetime

Systolic Blood pressure (mmHg)
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure (mmHg)
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Randomisation Number
Description

Randomisation Number

Was the subject able to be randomised?
Description

Subject Randomisation

Data type

boolean

Randomisation Number
Description

Randomisation Number

Data type

integer

Investigational Product (Dose)
Description

Investigational Product (Dose)

Date and Time of Dose
Description

Dose Date and Time

Data type

datetime

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

Treatment Confirmation

Data type

boolean

Record reasons for incorrect treatment
Description

Incorrect Treatment Reasons

Data type

text

Vital Signs (Dosing)
Description

Vital Signs (Dosing)

Choose Dose Time
Description

Dose Time

Data type

integer

Blood Pressure - Systolic
Description

Blood Pressure - Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure - Diastolic
Description

Blood Pressure - Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Temperature (Dosing)
Description

Temperature (Dosing)

Choose Dose Time
Description

Dose Time

Data type

integer

t° Reading1
Description

t° Reading1

Data type

float

Measurement units
  • °C
°C
t° Reading2
Description

t° Reading2

Data type

float

Measurement units
  • °C
°C
t° Reading3
Description

t° Reading3

Data type

float

Measurement units
  • °C
°C
Hematology (Dosing)
Description

Hematology (Dosing)

Choose Dose Time
Description

Dose Time

Data type

integer

Has the subject fasted?
Description

Fasting

Data type

boolean

WBC
Description

WBC

Data type

text

Alias
UMLS CUI [1]
C0023508
RBC
Description

RBC

Data type

text

Alias
UMLS CUI [1]
C0014772
Haemoglobin
Description

Hemoglobin measurement

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Lymphocytes
Description

Lymphocytes

Data type

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0026473
10^9/L
Eosinophils
Description

Eosinophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200638
10^9/L
Basophils
Description

Basophils

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0200641
10^9/L
Platelets
Description

Platelets

Data type

float

Measurement units
  • 10^9/ L
Alias
UMLS CUI [1]
C0005821
10^9/ L
Reticulocyte count
Description

Reticulocyte count

Data type

float

Alias
UMLS CUI [1]
C0206161
MCV
Description

MCV

Data type

integer

Measurement units
  • fL
fL
MCH
Description

MCH

Data type

float

Measurement units
  • pg
Alias
UMLS CUI [1]
C0369183
pg
MCHC
Description

Mean corpuscular hemoglobin concentration determination

Data type

float

Alias
UMLS CUI [1]
C0474535
Date of test
Description

Test Date

Data type

date

Clinical Chemistry
Description

Clinical Chemistry

Choose Dose Time
Description

Dose Time

Data type

text

Has the subject fasted?
Description

Fasting

Data type

boolean

ALT
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST
Description

Chemistry, Clinical; Aspartate aminotransferase measurement

Data type

float

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

Total Bilirubin

Data type

text

Alias
UMLS CUI [1]
C0201913
Glucose
Description

Glucose

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
GGT
Description

Chemistry, Clinical; Gamma glutamyl transferase measurement

Data type

float

Alias
UMLS CUI [1]
C0202035
Total Protein
Description

Chemistry, Clinical; Total Protein measurement

Data type

float

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

Albumin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Chloride
Description

Chloride

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0201952
mmol/L
Creatinine
Description

Chemistry, Clinical, Creatinine measurement

Data type

float

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

Chemistry, Clinical; Uric acid

Data type

float

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

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
[BUN] BUN
Description

BUN

Data type

float

Measurement units
  • mg/dL
mg/dL
Cholesterol
Description

Cholesterol

Data type

float

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

Carbon dioxide total measurement; Result; Data Type -Character

Data type

text

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

Triglycerides

Data type

float

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

LDH

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Calcium
Description

Calcium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Plasma ACTH
Description

Plasma ACTH

Data type

text

Serum Progesterone
Description

Serum Progesterone

Data type

text

Serum cortisol
Description

Serum cortisol

Data type

text

Measurement units
  • g/dL
g/dL
Serum testosterone
Description

Serum testosterone

Data type

text

SHBG
Description

SHBG

Data type

text

Measurement units
  • nmol/l
Alias
UMLS CUI [1]
C0202218
nmol/l
Electrocardiogram
Description

Electrocardiogram

Choose Dose Time
Description

Dose Time

Data type

integer

Time of ECG
Description

Time of ECG

Data type

time

Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Description

Electrocardiogram: P-R interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS complex duration (observable entity)

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

QT interval - finding

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Description

qtc interval; Evaluation Method

Data type

integer

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

Result of the ECG

Data type

integer

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

Peak Nasal Inspiratory Flow Rate

Choose Time of Test
Description

Test Time

Data type

text

PNIF (reading 1)
Description

PNIF (reading 1)

Data type

integer

PNIF (reading 2)
Description

PNIF (reading 2)

Data type

integer

PNIF reading 3
Description

PNIF reading 3

Data type

integer

Total Symptom Score
Description

Total Symptom Score

Choose the Dose Time
Description

Dose Time

Data type

integer

Nasal congestion score
Description

Nasal congestion score

Data type

integer

Rhinorrhoea score
Description

Rhinorrhoea score

Data type

integer

Lacrimation score
Description

Lacrimation score

Data type

integer

Burning/pain score
Description

Burning/pain score

Data type

integer

Total Symptom Score
Description

Total Symptom Score

Data type

text

Visual Analogue Scale
Description

Visual Analogue Scale

Choose Dose Time (assessment time)
Description

Dose Time

Data type

integer

Nasal congestion VAS score
Description

Nasal congestion VAS score

Data type

integer

Measurement units
  • mm
mm
Rhinorrhoea VAS Score
Description

Rhinorrhoea VAS Score

Data type

text

Measurement units
  • mm
mm
Lacrimation VAS score
Description

Lacrimation VAS score

Data type

integer

Measurement units
  • mm
mm
Burning/pain VAS score
Description

Burning/pain VAS score

Data type

integer

Measurement units
  • mm
mm
Nostril Secretions
Description

Nostril Secretions

Choose the Dose Time
Description

Dose Time

Data type

integer

Actual start time
Description

Actual start time

Data type

time

Actual end time
Description

Actual end time

Data type

time

Acciwik Left Nostril secretion weight
Description

Acciwik Left Nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Tissue Left Nostril secretion weight
Description

Tissue Left Nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Acciwik Right Nostril secretion weight
Description

Acciwik Right Nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Tissue Right Nostril secretion weight
Description

Tissue Right Nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Choose the Dose Time
Description

Dose Time

Data type

integer

Actual time
Description

Actual time

Data type

time

Similar models

Period 1

  1. StudyEvent: ODM
    1. Period 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Vital Signs Pre-Challenge
Actual Date / Time
Item
Actual Date and Time
datetime
Systolic Blood Pressure
Item
Systolic Blood pressure (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood pressure (mmHg)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Randomisation Number
Subject Randomisation
Item
Was the subject able to be randomised?
boolean
Randomisation Number
Item
Randomisation 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
Pre-Dose (1)
CL Item
30 min (2)
CL Item
60 min (3)
CL Item
120 min (4)
CL Item
3 hrs (5)
CL Item
4 hrs (6)
CL Item
5 hrs (7)
CL Item
6 hrs (8)
Actual time
Item
Actual time
time

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