ID

35615

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. 3/12/19 3/12/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 12, 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

Visit 1

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

Administrative data

Date of Visit
Description

Visit Date

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Placebo
Description

Placebo

Date and time of challenge
Description

Date and Time

Data type

datetime

Nostril
Description

Nostril

Data type

text

Capsaicin challenge - Challenge 1
Description

Capsaicin challenge - Challenge 1

Actual Time
Description

Actual Time

Data type

time

challenge dose
Description

challenge dose

Data type

integer

Measurement units
  • mg
mg
Nostril
Description

Nostril

Data type

text

Capsaicin challenge - Challenge 2
Description

Capsaicin challenge - Challenge 2

Actual Time
Description

Actual Time

Data type

time

challenge dose
Description

challenge dose

Data type

integer

Measurement units
  • mg
mg
Nostril
Description

Nostril

Data type

text

Capsaicin challenge - Challenge 3
Description

Capsaicin challenge - Challenge 3

Actual Time
Description

Actual Time

Data type

time

challenge dose
Description

challenge dose

Data type

integer

Measurement units
  • mg
mg
Nostril
Description

Nostril

Data type

text

Peak Nasal Inspiratory Flow Rate
Description

Peak Nasal Inspiratory Flow Rate

Time of test
Description

Challenge time

Data type

integer

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

Actual time
Description

Challenge 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

Placebo challenge date and time
Description

Placebo challenge date and time

Data type

datetime

Visual Analogue Scale
Description

Visual Analogue Scale

Actual time
Description

Challenge time

Data type

text

Nasal congestion VAS score
Description

Nasal congestion VAS score

Data type

integer

Measurement units
  • mm
mm
RhinorrhoeaVAS score
Description

RhinorrhoeaVAS score

Data type

integer

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
Placebo challenge date and time
Description

Placebo challenge date and time

Data type

datetime

Nostril Secretions
Description

Nostril Secretions

Time
Description

Challenge time

Data type

integer

Actual start time
Description

Challenge start time

Data type

time

Actual End time
Description

Challenge end time

Data type

time

Left nostril secretion weight
Description

Left nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Right nostril secretion weight
Description

Right nostril secretion weight

Data type

float

Measurement units
  • mg
mg
Placebo challenge date and time
Description

Placebo challenge date and time

Data type

datetime

Nostril Secretions - Tissue Weights Only
Description

Nostril Secretions - Tissue Weights Only

Time
Description

Time

Data type

text

Tissue Left Nostril secretion weight
Description

Tissue Left 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
Placebo challenge date and time
Description

Placebo challenge date and time

Data type

datetime

Nostril Secretions
Description

Nostril Secretions

Time
Description

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
Placebo challenge date and time
Description

Placebo challenge date and time

Data type

datetime

Similar models

Visit 1

  1. StudyEvent: ODM
    1. Visit 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
Placebo
Date and Time
Item
Date and time of challenge
datetime
Item
Nostril
text
Code List
Nostril
CL Item
Left (1)
CL Item
Right (2)
Item Group
Capsaicin challenge - Challenge 1
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
Item
Nostril
text
Code List
Nostril
CL Item
Left (1)
CL Item
Right (2)
Item Group
Capsaicin challenge - Challenge 2
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
Item
Nostril
text
Code List
Nostril
CL Item
Left (1)
CL Item
Right (2)
Item Group
Capsaicin challenge - Challenge 3
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
Item
Nostril
text
Code List
Nostril
CL Item
Left (1)
CL Item
Right (2)
Item Group
Peak Nasal Inspiratory Flow Rate
Item
Time of test
integer
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
Total Symptom Score
Item
Actual time
integer
Code List
Actual time
CL Item
1 min (1)
CL Item
5 min (2)
CL Item
10 min (3)
CL Item
21 min (4)
CL Item
25 min (5)
CL Item
30 min (6)
CL Item
41 min (7)
CL Item
45 min (8)
CL Item
50 min (9)
CL Item
61 min (10)
CL Item
65 min (11)
CL Item
70 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
Placebo challenge date and time
Item
Placebo challenge date and time
datetime
Item Group
Visual Analogue Scale
Item
Actual time
text
Code List
Actual time
CL Item
1 min (1)
CL Item
5 min (2)
CL Item
10 min (3)
CL Item
21 min (4)
CL Item
25 min (5)
CL Item
30 min (6)
CL Item
41 min (7)
CL Item
45 min (8)
CL Item
50 min (9)
CL Item
61 min (10)
CL Item
65 min (11)
CL Item
70 min (12)
Nasal congestion VAS score
Item
Nasal congestion VAS score
integer
RhinorrhoeaVAS score
Item
RhinorrhoeaVAS score
integer
Lacrimation VAS score
Item
Lacrimation VAS score
integer
Burning/pain VAS score
Item
Burning/pain VAS score
integer
Placebo challenge date and time
Item
Placebo challenge date and time
datetime
Item Group
Nostril Secretions
Item
Time
integer
Code List
Time
CL Item
1-4 min  (1)
CL Item
5-8 min (2)
CL Item
9-12 min (3)
CL Item
21-24 min (4)
CL Item
25-28 min (5)
CL Item
29-32 min (6)
CL Item
41-44 min (7)
CL Item
45-48 min (8)
CL Item
49-52 min (9)
CL Item
61-64 min (10)
CL Item
65-68 min (11)
CL Item
69-72 min (12)
Challenge start time
Item
Actual start time
time
Challenge end time
Item
Actual End time
time
Left nostril secretion weight
Item
Left nostril secretion weight
float
Right nostril secretion weight
Item
Right nostril secretion weight
float
Placebo challenge date and time
Item
Placebo challenge date and time
datetime
Item Group
Nostril Secretions - Tissue Weights Only
Item
Time
text
Code List
Time
CL Item
1-4 min (1)
CL Item
5-8 min (2)
CL Item
9-12 min (3)
CL Item
21-24 min (5)
CL Item
25-28 min (6)
CL Item
29-32 min (7)
CL Item
41-44 min (8)
CL Item
45-48 min (9)
CL Item
49-52 min (10)
CL Item
61-64 min (11)
CL Item
65-68 min (12)
CL Item
69-72 min (13)
Tissue Left Nostril secretion weight
Item
Tissue Left Nostril secretion weight
float
Tissue Right Nostril secretion weight
Item
Tissue Right Nostril secretion weight
float
Placebo challenge date and time
Item
Placebo challenge date and time
datetime
Item Group
Nostril Secretions
Item
Time
integer
Code List
Time
CL Item
1-3 min (1)
CL Item
5-7 min (2)
CL Item
9-11 min (3)
CL Item
21-23 min (5)
CL Item
25-27 min (6)
CL Item
29-32 min (7)
CL Item
41-43 min (8)
CL Item
45-47 min (9)
CL Item
49-51 min (10)
CL Item
61-63 min (11)
CL Item
65-67 min (12)
CL Item
69-71 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
Placebo challenge date and time
Item
Placebo challenge date and time
datetime

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