ID
38818
Description
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis
Keywords
Versions (1)
- 11/6/19 11/6/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 6, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933
Visual Nasal Examination (Period 1 - 5; Day 1 - Day 16)
- StudyEvent: ODM
Description
Repeat Visual Nasal Endoscopy (Day 1 - 13)
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205341
Description
Time point of assessment
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348792
- UMLS CUI [1,2]
- C0220825
Description
Date/ Time of Assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
Description
Left nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Left nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal infection
Data type
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Data type
text
Alias
- UMLS CUI [1]
- C1739415
Description
Crusting
Data type
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Data type
text
Alias
- UMLS CUI [1]
- C0019080
Description
If signs of bleeding, specify location
Data type
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Description
Repeat Visual Nasal Endoscopy (Day 14 - 16)
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205341
Description
Time point of assessment
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348792
- UMLS CUI [1,2]
- C0220825
Description
Date/ Time of Assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
Description
Left nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Left nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal infection
Data type
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Data type
text
Alias
- UMLS CUI [1]
- C1739415
Description
Crusting
Data type
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Data type
text
Alias
- UMLS CUI [1]
- C0019080
Description
If signs of bleeding, specify location
Data type
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Similar models
Visual Nasal Examination (Period 1 - 5; Day 1 - Day 16)
- StudyEvent: ODM
C0205341 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205341 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205341 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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