ID

35636

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 2

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

Administrative data

Visit Date
Description

Visit Date

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Investigational Product (Dose)
Description

Investigational Product (Dose)

Dose Date and Time
Description

Dose Date and Time

Data type

datetime

Treatment Confirmation
Description

Treatment Confirmation

Data type

boolean

Incorrect Treatment Reasons
Description

Incorrect Treatment Reasons

Data type

text

Vital Signs (Dosing)
Description

Vital Signs (Dosing)

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)

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)

Dose Time
Description

Dose Time

Data type

integer

Fasting
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
Hemoglobin measurement
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
Mean corpuscular hemoglobin concentration determination
Description

Mean corpuscular hemoglobin concentration determination

Data type

float

Alias
UMLS CUI [1]
C0474535
Test Date
Description

Test Date

Data type

date

Clinical Chemistry
Description

Clinical Chemistry

Dose Time
Description

Dose Time

Data type

text

Fasting
Description

Fasting

Data type

boolean

ALT
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
Chemistry, Clinical; Aspartate aminotransferase measurement
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
Chemistry, Clinical; Gamma glutamyl transferase measurement
Description

Chemistry, Clinical; Gamma glutamyl transferase measurement

Data type

float

Alias
UMLS CUI [1]
C0202035
Chemistry, Clinical; Total Protein measurement
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
Chemistry, Clinical, Creatinine measurement
Description

Chemistry, Clinical, Creatinine measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201975
Chemistry, Clinical; 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
Description

BUN

Data type

float

Measurement units
  • mg/dL
mg/dL
Cholesterol
Description

Cholesterol

Data type

float

Alias
UMLS CUI [1]
C1445957
Carbon dioxide total measurement; Result; Data Type -Character
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
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

Treatment ID=1339

Data type

text

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

Electrocardiogram

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
Electrocardiogram: P-R interval
Description

Electrocardiogram: P-R interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS complex duration (observable entity)
Description

QRS complex duration (observable entity)

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT interval - finding
Description

QT interval - finding

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
qtc interval; Evaluation Method
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

Test Time
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

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

Dose 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

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

Dose Time
Description

Dose Time

Data type

integer

Actual time
Description

Actual time

Data type

time

Similar models

Period 2

  1. StudyEvent: ODM
    1. Period 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Visit Date
Item
date
Subject Number
Item
integer
Dose Date and Time
Item
datetime
Treatment Confirmation
Item
boolean
Incorrect Treatment Reasons
Item
text
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
CL Item
 (9)
CL Item
 (10)
CL Item
 (11)
Blood Pressure - Systolic
Item
integer
Blood Pressure - Diastolic
Item
integer
Heart Rate
Item
integer
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
CL Item
 (9)
CL Item
 (10)
CL Item
 (11)
t° Reading1
Item
float
t° Reading2
Item
float
t° Reading3
Item
float
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
Fasting
Item
boolean
WBC
Item
text
C0023508 (UMLS CUI [1])
RBC
Item
text
C0014772 (UMLS CUI [1])
Hemoglobin measurement
Item
float
C0518015 (UMLS CUI [1])
Neutrophils
Item
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
text
C0200635 (UMLS CUI [1])
Monocytes
Item
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
float
C0200638 (UMLS CUI [1])
Basophils
Item
float
C0200641 (UMLS CUI [1])
Platelets
Item
float
C0005821 (UMLS CUI [1])
Reticulocyte count
Item
float
C0206161 (UMLS CUI [1])
MCV
Item
integer
MCH
Item
float
C0369183 (UMLS CUI [1])
Mean corpuscular hemoglobin concentration determination
Item
float
C0474535 (UMLS CUI [1])
Test Date
Item
date
Item
text
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
Fasting
Item
boolean
ALT
Item
float
C0201836 (UMLS CUI [1])
Chemistry, Clinical; Aspartate aminotransferase measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Total Bilirubin
Item
text
C0201913 (UMLS CUI [1])
Glucose
Item
float
C0202042 (UMLS CUI [1])
Chemistry, Clinical; Gamma glutamyl transferase measurement
Item
float
C0202035 (UMLS CUI [1])
Chemistry, Clinical; Total Protein measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0555903 (UMLS CUI [1,2])
Albumin
Item
float
C0201838 (UMLS CUI [1])
Potassium
Item
float
C0202194 (UMLS CUI [1])
Sodium
Item
float
C0337443 (UMLS CUI [1])
Chloride
Item
float
C0201952 (UMLS CUI [1])
Chemistry, Clinical, Creatinine measurement
Item
float
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Chemistry, Clinical; Uric acid
Item
float
C0008000 (UMLS CUI [1,1])
C0041980 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
float
C0201850 (UMLS CUI [1])
BUN
Item
float
Cholesterol
Item
float
C1445957 (UMLS CUI [1])
Carbon dioxide total measurement; Result; Data Type -Character
Item
text
C0860709 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Triglycerides
Item
float
C0202236 (UMLS CUI [1])
LDH
Item
float
C0202113 (UMLS CUI [1])
Calcium
Item
float
C0201925 (UMLS CUI [1])
Plasma ACTH
Item
text
Code List
Serum Progesterone
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Serum cortisol
Item
text
Serum testosterone
Item
text
SHBG
Item
SHBG
text
C0202218 (UMLS CUI [1])
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
Time of ECG
Item
time
Heart rate
Item
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
float
C1287082 (UMLS CUI [1])
Item
integer
C0489625 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
qtc interval; Evaluation Method
CL Item
 (1)
CL Item
 (2)
Item
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
text
Code List
Test Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
PNIF (reading 1)
Item
integer
PNIF (reading 2)
Item
integer
PNIF reading 3
Item
integer
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
CL Item
 (9)
CL Item
 (10)
CL Item
 (11)
CL Item
 (12)
Nasal congestion score
Item
integer
Rhinorrhoea score
Item
integer
Lacrimation score
Item
integer
Burning/pain score
Item
integer
Total Symptom Score
Item
text
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
CL Item
 (9)
CL Item
 (10)
CL Item
 (11)
CL Item
 (12)
Nasal congestion VAS score
Item
integer
Rhinorrhoea VAS Score
Item
text
Lacrimation VAS score
Item
integer
Burning/pain VAS score
Item
integer
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
CL Item
 (9)
CL Item
 (10)
CL Item
 (11)
CL Item
 (12)
CL Item
 (13)
Actual start time
Item
time
Actual end time
Item
time
Acciwik Left Nostril secretion weight
Item
float
Tissue Left Nostril secretion weight
Item
float
Acciwik Right Nostril secretion weight
Item
float
Tissue Right Nostril secretion weight
Item
float
Item
integer
Code List
Dose Time
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
CL Item
 (7)
CL Item
 (8)
Actual time
Item
time

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