Informações:
Falhas:
ID
38817
Descrição
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
Palavras-chave
Versões (1)
- 06/11/2019 06/11/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
6 de novembro de 2019
DOI
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Licença
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
Similar models
Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Visual Analogue Scale - Dosing Date and Time (Period 1 - 5)
C2959685 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
AM Dosing date/ time
Item
AM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date/ time
Item
PM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Visual Analogue Scale (Period 1 - 5)
C2959685 (UMLS CUI-1)
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:15 m (9)
CL Item
12 hr:30 m (10)
CL Item
13 hr (11)
CL Item
14 hr (12)
CL Item
16 hr (13)
CL Item
20 hr (14)
CL Item
24 hr (15)
CL Item
Not Done (ND)
Date/ Time of assessment
Item
Date/ Time of assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Nose not runny/Nose extremely runny
Item
Nose not runny/Nose extremely runny
integer
C1260880 (UMLS CUI [1])
Nose clear/Nose completely blocked
Item
Nose clear/Nose completely blocked
integer
C0027424 (UMLS CUI [1])
Nose not itchy/Nose extremely itchy
Item
Nose not itchy/Nose extremely itchy
integer
C0850060 (UMLS CUI [1])
Nose not sore/Nose as sore as it has ever been
Item
Nose not sore/Nose as sore as it has ever been
integer
C0857495 (UMLS CUI [1])
Nose not dry/Nose as dry as it has ever been
Item
Nose not dry/Nose as dry as it has ever been
integer
C0231919 (UMLS CUI [1])
Throat not sore/Throat as sore as it has ever been
Item
Throat not sore/Throat as sore as it has ever been
integer
C0242429 (UMLS CUI [1])
Sense of taste normal/ Sense of taste completely abnormal
Item
Sense of taste normal/ Sense of taste completely abnormal
integer
C0039336 (UMLS CUI [1])
Taste nothing/Taste something very strongly
Item
Taste nothing/Taste something very strongly
integer
C1301555 (UMLS CUI [1])
Sense of smell normal/ Sense of smell completely abnormal
Item
Sense of smell normal/ Sense of smell completely abnormal
integer
C0037361 (UMLS CUI [1])
Smell nothing/Smell something very strongly
Item
Smell nothing/Smell something very strongly
integer
C2712084 (UMLS CUI [1])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
integer
C0231918 (UMLS CUI [1])
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
text
C0231918 (UMLS CUI [1])
CL Item
No additional symptoms (NA)
CL Item
Specify symptom (?)
Specify symptom
Item
Specify symptom
text
C1457887 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Visual Analogue Scale (Day 3 - Day 13)
C2959685 (UMLS CUI-1)
CL Item
Day 3 (1)
CL Item
Day 4 (2)
CL Item
Day 5 (3)
CL Item
Day 6 (4)
CL Item
Day 7 (5)
CL Item
Day 8 (6)
CL Item
Day 9 (7)
CL Item
Day 10 (8)
CL Item
Day 11 (9)
CL Item
Day 12 (10)
CL Item
Day 13 (11)
AM Dosing date/ time
Item
AM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date/ time
Item
PM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
CL Item
1 hr post AM dose (1)
CL Item
1 hr post PM dose (2)
Date/ Time of assessment
Item
Date/ Time of assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Nose not runny/Nose extremely runny
Item
Nose not runny/Nose extremely runny
integer
C1260880 (UMLS CUI [1])
Nose clear/Nose completely blocked
Item
Nose clear/Nose completely blocked
integer
C0027424 (UMLS CUI [1])
Nose not itchy/Nose extremely itchy
Item
Nose not itchy/Nose extremely itchy
integer
C0850060 (UMLS CUI [1])
Nose not sore/Nose as sore as it has ever been
Item
Nose not sore/Nose as sore as it has ever been
integer
C0857495 (UMLS CUI [1])
Nose not dry/Nose as dry as it has ever been
Item
Nose not dry/Nose as dry as it has ever been
integer
C0231919 (UMLS CUI [1])
Throat not sore/Throat as sore as it has ever been
Item
Throat not sore/Throat as sore as it has ever been
integer
C0242429 (UMLS CUI [1])
Sense of taste normal/ Sense of taste completely abnormal
Item
Sense of taste normal/ Sense of taste completely abnormal
integer
C0039336 (UMLS CUI [1])
Taste nothing/Taste something very strongly
Item
Taste nothing/Taste something very strongly
integer
C1301555 (UMLS CUI [1])
Sense of smell normal/ Sense of smell completely abnormal
Item
Sense of smell normal/ Sense of smell completely abnormal
integer
C0037361 (UMLS CUI [1])
Smell nothing/Smell something very strongly
Item
Smell nothing/Smell something very strongly
integer
C2712084 (UMLS CUI [1])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
integer
C0231918 (UMLS CUI [1])
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
text
C0231918 (UMLS CUI [1])
Code List
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
CL Item
No additional symptoms (NA)
CL Item
Specify symptom (?)
Specify symptom
Item
Specify symptom
text
C1457887 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Visual Analogue Scale - Dosing date/ time (Day 14 - 16)
C2959685 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
AM Dosing date/ time
Item
AM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date/ time
Item
PM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Visual Analogue Scale (Day 14 - 16)
C2959685 (UMLS CUI-1)
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (9)
CL Item
12 hr:15 m (10)
CL Item
12 hr:30 m (11)
CL Item
13 hr (12)
CL Item
14 hr (13)
CL Item
16 hr (14)
CL Item
20 hr (15)
CL Item
24 hr (16)
CL Item
36 hr (17)
CL Item
48 hr (18)
CL Item
60 hr (19)
Date/ Time of assessment
Item
Date/ Time of assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Nose not runny/Nose extremely runny
Item
Nose not runny/Nose extremely runny
integer
C1260880 (UMLS CUI [1])
Nose clear/Nose completely blocked
Item
Nose clear/Nose completely blocked
integer
C0027424 (UMLS CUI [1])
Nose not itchy/Nose extremely itchy
Item
Nose not itchy/Nose extremely itchy
integer
C0850060 (UMLS CUI [1])
Nose not sore/Nose as sore as it has ever been
Item
Nose not sore/Nose as sore as it has ever been
integer
C0857495 (UMLS CUI [1])
Nose not dry/Nose as dry as it has ever been
Item
Nose not dry/Nose as dry as it has ever been
integer
C0231919 (UMLS CUI [1])
Throat not sore/Throat as sore as it has ever been
Item
Throat not sore/Throat as sore as it has ever been
integer
C0242429 (UMLS CUI [1])
Sense of taste normal/ Sense of taste completely abnormal
Item
Sense of taste normal/ Sense of taste completely abnormal
integer
C0039336 (UMLS CUI [1])
Taste nothing/Taste something very strongly
Item
Taste nothing/Taste something very strongly
integer
C1301555 (UMLS CUI [1])
Sense of smell normal/ Sense of smell completely abnormal
Item
Sense of smell normal/ Sense of smell completely abnormal
integer
C0037361 (UMLS CUI [1])
Smell nothing/Smell something very strongly
Item
Smell nothing/Smell something very strongly
integer
C2712084 (UMLS CUI [1])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
integer
C0231918 (UMLS CUI [1])
Item
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
text
C0231918 (UMLS CUI [1])
Code List
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
CL Item
No additional symptoms (NA)
CL Item
Specify symptom (?)
Specify symptom
Item
Specify symptom
text
C1457887 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
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