ID
38817
Beschreibung
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
Stichworte
Versionen (1)
- 06.11.19 06.11.19 -
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GlaxoSmithKline
Hochgeladen am
6. November 2019
DOI
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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
Beschreibung
Visual Analogue Scale (Period 1 - 5)
Alias
- UMLS CUI-1
- C2959685
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Please check if not done
Datentyp
text
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Date/ Time of assessment
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschreibung
Nose not runny/Nose extremely runny
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1260880
Beschreibung
Nose clear/Nose completely blocked
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0027424
Beschreibung
Nose not itchy/Nose extremely itchy
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0850060
Beschreibung
Nose not sore/Nose as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0857495
Beschreibung
Nose not dry/Nose as dry as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231919
Beschreibung
Throat not sore/Throat as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0242429
Beschreibung
Sense of taste normal/ Sense of taste completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0039336
Beschreibung
Taste nothing/Taste something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1301555
Beschreibung
Sense of smell normal/ Sense of smell completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0037361
Beschreibung
Smell nothing/Smell something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C2712084
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
text
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Specify symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Beschreibung
Visual Analogue Scale (Day 3 - Day 13)
Alias
- UMLS CUI-1
- C2959685
Beschreibung
Day of assessment
Datentyp
integer
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
AM Dosing date/ time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C4331833
Beschreibung
PM Dosing date/ time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C1509133
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Date/ Time of assessment
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschreibung
Nose not runny/Nose extremely runny
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1260880
Beschreibung
Nose clear/Nose completely blocked
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0027424
Beschreibung
Nose not itchy/Nose extremely itchy
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0850060
Beschreibung
Nose not sore/Nose as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0857495
Beschreibung
Nose not dry/Nose as dry as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231919
Beschreibung
Throat not sore/Throat as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0242429
Beschreibung
Sense of taste normal/ Sense of taste completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0039336
Beschreibung
Taste nothing/Taste something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1301555
Beschreibung
Sense of smell normal/ Sense of smell completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0037361
Beschreibung
Smell nothing/Smell something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C2712084
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
text
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Specify symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Beschreibung
Visual Analogue Scale - Dosing date/ time (Day 14 - 16)
Alias
- UMLS CUI-1
- C2959685
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C1264639
Beschreibung
AM Dosing date/ time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C4331833
Beschreibung
PM Dosing date/ time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1264639
- UMLS CUI [1,3]
- C1509133
Beschreibung
Visual Analogue Scale (Day 14 - 16)
Alias
- UMLS CUI-1
- C2959685
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Date/ Time of assessment
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beschreibung
Nose not runny/Nose extremely runny
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1260880
Beschreibung
Nose clear/Nose completely blocked
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0027424
Beschreibung
Nose not itchy/Nose extremely itchy
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0850060
Beschreibung
Nose not sore/Nose as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0857495
Beschreibung
Nose not dry/Nose as dry as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231919
Beschreibung
Throat not sore/Throat as sore as it has ever been
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0242429
Beschreibung
Sense of taste normal/ Sense of taste completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0039336
Beschreibung
Taste nothing/Taste something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C1301555
Beschreibung
Sense of smell normal/ Sense of smell completely abnormal
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0037361
Beschreibung
Smell nothing/Smell something very strongly
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C2712084
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datentyp
text
Alias
- UMLS CUI [1]
- C0231918
Beschreibung
Specify symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2348235
Ähnliche Modelle
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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