ID
38652
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-10-29 2019-10-29 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 oktober 2019
DOI
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Licens
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
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Beskrivning
If other abnormal rhythm, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Beskrivning
If other P-Wave Morphology, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Beskrivning
If other conduction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Beskrivning
If other myocardial infarction, enter comment.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Beskrivning
If other depololarisation/repolarisation, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beskrivning
If other abnormalities, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Repeat Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0205341
Beskrivning
Repeat Visual Analogue Scale
Alias
- UMLS CUI-1
- C2959685
- UMLS CUI-2
- C0205341
Beskrivning
Date/ Time of assessment
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beskrivning
Nose not runny/Nose extremely runny
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C1260880
Beskrivning
Nose clear/Nose completely blocked
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0027424
Beskrivning
Nose not itchy/Nose extremely itchy
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0850060
Beskrivning
Nose not sore/Nose as sore as it has ever been
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0857495
Beskrivning
Nose not dry/Nose as dry as it has ever been
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0231919
Beskrivning
Throat not sore/Throat as sore as it has ever been
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0242429
Beskrivning
Sense of taste normal/ Sense of taste completely abnormal
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0039336
Beskrivning
Taste nothing/Taste something very strongly
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C1301555
Beskrivning
Sense of smell normal/ Sense of smell completely abnormal
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0037361
Beskrivning
Smell nothing/Smell something very strongly
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C2712084
Beskrivning
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1]
- C0231918
Beskrivning
Repeat Visual Nasal Endoscopy
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205341
Beskrivning
Date/ Time of Assessment
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Beskrivning
Left Nostril Colour
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Beskrivning
Right Nostril Colour
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Beskrivning
Left nostril concha media turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
Beskrivning
Left nostril concha inferior turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Beskrivning
Right nostril concha media turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beskrivning
Right nostril concha inferior turbinate swelling
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Beskrivning
Alignment of the Septum
Datatyp
text
Alias
- UMLS CUI [1]
- C0027432
Beskrivning
Severity of right deviation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232296
- UMLS CUI [1,2]
- C0439793
Beskrivning
Severity of left deviation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232297
- UMLS CUI [1,2]
- C0439793
Beskrivning
Left nostril secretions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Beskrivning
Right nostril secretions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Beskrivning
Nasal infection
Datatyp
text
Alias
- UMLS CUI [1]
- C0555970
Beskrivning
Post Nasal Drip
Datatyp
text
Alias
- UMLS CUI [1]
- C1739415
Beskrivning
Crusting
Datatyp
text
Alias
- UMLS CUI [1]
- C0205204
Beskrivning
Signs of Bleeding
Datatyp
text
Alias
- UMLS CUI [1]
- C0019080
Beskrivning
If signs of bleeding, specify location
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Beskrivning
Presence of nasal polyps
Datatyp
text
Alias
- UMLS CUI [1]
- C0027430
Beskrivning
If presece of nasal polyps, specify location
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Similar models
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0205341 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0205341 (UMLS CUI-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])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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