ID
38602
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)
- 10/26/19 10/26/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 26, 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
Screen - Date of Visit; Demography; Eligibility Question; Subject Identification; Randomisation Number; Nasal Endoscopy
Description
Inform Enrolment
Alias
- UMLS CUI-1
- C1552002
- UMLS CUI-2
- C4041024
Description
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Geography ancestry
Data type
integer
Alias
- UMLS CUI [1]
- C3841890
Description
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Description
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Was the subject able to be randomised?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Description
If subject was able to be randomised, provide randomisation number
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0034656
- UMLS CUI [2,2]
- C0237753
Description
If subject was able to be randomised, enter date of randomisation
Data type
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0034656
- UMLS CUI [2,2]
- C0011008
Description
Nasal Endoscopy - Screening
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0220908
Description
Nasal Endoscopy - Colour of Mucosa
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0475705
Description
Nasal Endoscopy - Turbinate Swelling
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0038999
- UMLS CUI-3
- C1266928
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
- UMLS CUI [1,4]
- C0038999
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
Nasal Endoscopy - Alignment of the Septum
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0027432
Description
Alignment of the Septum
Data type
text
Alias
- UMLS CUI [1]
- C0027432
Description
Severity of right deviation
Data type
text
Alias
- UMLS CUI [1,1]
- C0232296
- UMLS CUI [1,2]
- C0439793
Description
Severity of left deviation
Data type
text
Alias
- UMLS CUI [1,1]
- C0232297
- UMLS CUI [1,2]
- C0439793
Description
Nasal Endoscopy - Secretions
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0036537
Description
Nasal Endoscopy - Infection
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0009450
Description
Nasal Endoscopy - Post Nasal Drip
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C1739415
Description
Nasal Endoscopy - Crusting
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205204
Description
Nasal Endoscopy - Signs of Bleeding
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0019080
Description
Nasal Endoscopy - Nasal Polyps
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0027430
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