ID
38817
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 Analogue Scale (Period 1 - 5; Day 1 - Day 16)
- StudyEvent: ODM
Description
Visual Analogue Scale (Period 1 - 5)
Alias
- UMLS CUI-1
- C2959685
Description
Timepoint
Data type
integer
Alias
- UMLS CUI [1]
- C2348792
Description
Please check if not done
Data type
text
Alias
- UMLS CUI [1]
- C1272696
Description
Date/ Time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Nose not runny/Nose extremely runny
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1260880
Description
Nose clear/Nose completely blocked
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0027424
Description
Nose not itchy/Nose extremely itchy
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0850060
Description
Nose not sore/Nose as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0857495
Description
Nose not dry/Nose as dry as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231919
Description
Throat not sore/Throat as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0242429
Description
Sense of taste normal/ Sense of taste completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0039336
Description
Taste nothing/Taste something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1301555
Description
Sense of smell normal/ Sense of smell completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0037361
Description
Smell nothing/Smell something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C2712084
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231918
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
text
Alias
- UMLS CUI [1]
- C0231918
Description
Specify symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Description
Visual Analogue Scale (Day 3 - Day 13)
Alias
- UMLS CUI-1
- C2959685
Description
Day of assessment
Data type
integer
Alias
- UMLS CUI [1]
- C2985720
Description
AM Dosing date/ time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C4331833
Description
PM Dosing date/ time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C1509133
Description
Timepoint
Data type
integer
Alias
- UMLS CUI [1]
- C2348792
Description
Date/ Time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Nose not runny/Nose extremely runny
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1260880
Description
Nose clear/Nose completely blocked
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0027424
Description
Nose not itchy/Nose extremely itchy
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0850060
Description
Nose not sore/Nose as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0857495
Description
Nose not dry/Nose as dry as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231919
Description
Throat not sore/Throat as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0242429
Description
Sense of taste normal/ Sense of taste completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0039336
Description
Taste nothing/Taste something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1301555
Description
Sense of smell normal/ Sense of smell completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0037361
Description
Smell nothing/Smell something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C2712084
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231918
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
text
Alias
- UMLS CUI [1]
- C0231918
Description
Specify symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Description
Visual Analogue Scale - Dosing date/ time (Day 14 - 16)
Alias
- UMLS CUI-1
- C2959685
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Description
AM Dosing date/ time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C4331833
Description
PM Dosing date/ time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C1509133
Description
Visual Analogue Scale (Day 14 - 16)
Alias
- UMLS CUI-1
- C2959685
Description
Timepoint
Data type
integer
Alias
- UMLS CUI [1]
- C2348792
Description
Date/ Time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Nose not runny/Nose extremely runny
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1260880
Description
Nose clear/Nose completely blocked
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0027424
Description
Nose not itchy/Nose extremely itchy
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0850060
Description
Nose not sore/Nose as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0857495
Description
Nose not dry/Nose as dry as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231919
Description
Throat not sore/Throat as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0242429
Description
Sense of taste normal/ Sense of taste completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0039336
Description
Taste nothing/Taste something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1301555
Description
Sense of smell normal/ Sense of smell completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0037361
Description
Smell nothing/Smell something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C2712084
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231918
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
text
Alias
- UMLS CUI [1]
- C0231918
Description
Specify symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Similar models
Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)
- StudyEvent: ODM
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
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