ID
38602
Descripción
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
Palabras clave
Versiones (1)
- 26/10/19 26/10/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de octubre de 2019
DOI
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Licencia
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
Descripción
Inform Enrolment
Alias
- UMLS CUI-1
- C1552002
- UMLS CUI-2
- C4041024
Descripción
Date of Visit
Alias
- UMLS CUI-1
- C1320303
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Sex
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Ethnicity
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0015031
Descripción
Geography ancestry
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3841890
Descripción
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Descripción
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Descripción
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Descripción
Was the subject able to be randomised?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Descripción
If subject was able to be randomised, provide randomisation number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0034656
- UMLS CUI [2,2]
- C0237753
Descripción
If subject was able to be randomised, enter date of randomisation
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [2,1]
- C0034656
- UMLS CUI [2,2]
- C0011008
Descripción
Nasal Endoscopy - Screening
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0220908
Descripción
Nasal Endoscopy - Colour of Mucosa
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0475705
Descripción
Nasal Endoscopy - Turbinate Swelling
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0038999
- UMLS CUI-3
- C1266928
Descripción
Left nostril concha media turbinate swelling
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Descripción
Left nostril concha inferior turbinate swelling
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Descripción
Right nostril concha media turbinate swelling
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Descripción
Right nostril concha inferior turbinate swelling
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Descripción
Nasal Endoscopy - Alignment of the Septum
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0027432
Descripción
Alignment of the Septum
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027432
Descripción
Severity of right deviation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0232296
- UMLS CUI [1,2]
- C0439793
Descripción
Severity of left deviation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0232297
- UMLS CUI [1,2]
- C0439793
Descripción
Nasal Endoscopy - Secretions
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0036537
Descripción
Nasal Endoscopy - Infection
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0009450
Descripción
Nasal Endoscopy - Post Nasal Drip
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C1739415
Descripción
Nasal Endoscopy - Crusting
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205204
Descripción
Nasal Endoscopy - Signs of Bleeding
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0019080
Descripción
Nasal Endoscopy - Nasal Polyps
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0027430
Descripción
Presence of nasal polyps
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027430
Descripción
If nasal polyps present, specify location
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
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Screen - Date of Visit; Demography; Eligibility Question; Subject Identification; Randomisation Number; Nasal Endoscopy
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C1720679 (UMLS CUI [1,3])
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C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0027432 (UMLS CUI-2)
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0036537 (UMLS CUI-2)
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0009450 (UMLS CUI-2)
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