Informações:
Falhas:
ID
35615
Descrição
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
Palavras-chave
Versões (1)
- 12/03/2019 12/03/2019 -
Titular dos direitos
GSK group of companies
Transferido a
12 de março de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
Similar models
Visit 1
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Date and Time
Item
Date and time of challenge
datetime
CL Item
Left (1)
CL Item
Right (2)
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
CL Item
Left (1)
CL Item
Right (2)
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
CL Item
Left (1)
CL Item
Right (2)
Actual Time
Item
Actual Time
time
challenge dose
Item
challenge dose
integer
CL Item
Left (1)
CL Item
Right (2)
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
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
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
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
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
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