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Informações:
Falhas:
ID
35603
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 (2)
- 11/03/2019 11/03/2019 -
- 12/03/2019 12/03/2019 -
Titular dos direitos
GSK group of companies
Transferido a
11 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.
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Screen Visit
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Initials
Item
Subject Initials
text
Date of birth
Item
Date of birth
date
Subject Number
Item
Subject Number
integer
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
CL Item
Part 1 (healthy volunteers; capsaicin challenge) (1)
CL Item
Part 2 (healthy volunteers; capsaicin challenge with treatment) (2)
Date of Birth
Item
Date of Birth
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
post- menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (10)
Actual date/time
Item
Actual date/time
datetime
Height
Item
Height
integer
Weight
Item
Weight
float
Body Mass Index
Item
Body Mass Index
float
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
integer
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Date and Time of ECG
Item
Date and Time of ECG
datetime
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
CL Item
machine (1)
CL Item
manual (2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
CL Item
Yes (1)
CL Item
No (2)
Specify violated criteria
Item
Specify violated criteria
text
Comment
Item
Comment
text
Actual date/time
Item
Actual date/time
datetime
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
Date/time of assessment
Item
Date/time of assessment
datetime
Nasal Congestion VAS Score
Item
Nasal Congestion VAS Score
text
Rhinorrhoea VAS Score
Item
Rhinorrhoea VAS Score
text
Lacrimation VAS Score
Item
Lacrimation VAS Score
text
Burning/Pain VAS Score
Item
Burning/Pain VAS Score
text
Date/time of test
Item
Date/time of test
datetime
PNIF reading 1
Item
PNIF reading 1
integer
PNIF reading 2
Item
PNIF reading 2
integer
PNIF reading 3
Item
PNIF reading 3
integer
Date/time of sample taken
Item
Date/time of sample taken
datetime
Has the subject fasted?
Item
Has the subject fasted?
boolean
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item Group
Local Laboratory - Clinical Chemistry (Lab C)
Date/time sample taken
Item
Date and Time sample taken
datetime
Has the subject fasted?
Item
Has the subject fasted?
boolean
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
boolean
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text