ID
35622
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
Versions (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
Repeating Logs Pt 2
- StudyEvent: ODM
Description
12-lead ECG Abnormalities
Description
Date of ECG
Data type
date
Description
Time of ECG
Data type
time
Description
Record clinically significant abnormalities below. Check all that apply:
Data type
integer
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0430456
Description
P-Wave and QRS Morphology
Data type
text
Description
12 lead ECG, Abnormality, Cardiac conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
Description
Myocardial Infraction
Data type
text
Description
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C0948857
Description
Other clinically significant abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0029481
- UMLS CUI [1,2]
- C2985739
Description
Laboratory Report
Description
Clinical Chemistry
Description
Clinical Chemistry Test
Data type
integer
Description
Laboratory Test Result
Data type
text
Description
Hematology Test
Description
Laboratory Test Result
Data type
text
Description
Hematology test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0332307
Description
Vital Signs
Description
Date and Time
Data type
datetime
Description
Blood Pressure - Systolic
Data type
float
Measurement units
- mmHg
Description
Blood Pressure - Diastolic
Data type
float
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Body Temperature
Data type
float
Measurement units
- °C
Description
Peak Nasal Inspiratory Flow Rate
Description
Pharmacokinetics Blood
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Repeating Logs Pt 2
- StudyEvent: ODM
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C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])