ID

38817

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)
  1. 6/11/19 6/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de noviembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

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

Inglés

Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)

1 formularios  
Visual Analogue Scale - Dosing Date and Time (Period 1 - 5)
Descripción

Visual Analogue Scale - Dosing Date and Time (Period 1 - 5)

Alias
UMLS CUI-1
C2959685
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
AM Dosing date/ time
Descripción

AM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date/ time
Descripción

PM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Visual Analogue Scale (Period 1 - 5)
Descripción

Visual Analogue Scale (Period 1 - 5)

Alias
UMLS CUI-1
C2959685
Timepoint
Descripción

Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348792
Please check if not done
Descripción

Please check if not done

Tipo de datos

text

Alias
UMLS CUI [1]
C1272696
Date/ Time of assessment
Descripción

Date/ Time of assessment

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Nose not runny/Nose extremely runny
Descripción

Nose not runny/Nose extremely runny

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1260880
mm
Nose clear/Nose completely blocked
Descripción

Nose clear/Nose completely blocked

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0027424
mm
Nose not itchy/Nose extremely itchy
Descripción

Nose not itchy/Nose extremely itchy

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0850060
mm
Nose not sore/Nose as sore as it has ever been
Descripción

Nose not sore/Nose as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0857495
mm
Nose not dry/Nose as dry as it has ever been
Descripción

Nose not dry/Nose as dry as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231919
mm
Throat not sore/Throat as sore as it has ever been
Descripción

Throat not sore/Throat as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0242429
mm
Sense of taste normal/ Sense of taste completely abnormal
Descripción

Sense of taste normal/ Sense of taste completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0039336
mm
Taste nothing/Taste something very strongly
Descripción

Taste nothing/Taste something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1301555
mm
Sense of smell normal/ Sense of smell completely abnormal
Descripción

Sense of smell normal/ Sense of smell completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0037361
mm
Smell nothing/Smell something very strongly
Descripción

Smell nothing/Smell something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C2712084
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231918
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

text

Alias
UMLS CUI [1]
C0231918
Specify symptom
Descripción

Specify symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348235
Visual Analogue Scale (Day 3 - Day 13)
Descripción

Visual Analogue Scale (Day 3 - Day 13)

Alias
UMLS CUI-1
C2959685
Day of assessment
Descripción

Day of assessment

Tipo de datos

integer

Alias
UMLS CUI [1]
C2985720
AM Dosing date/ time
Descripción

AM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date/ time
Descripción

PM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Timepoint
Descripción

Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348792
Date/ Time of assessment
Descripción

Date/ Time of assessment

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Nose not runny/Nose extremely runny
Descripción

Nose not runny/Nose extremely runny

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1260880
mm
Nose clear/Nose completely blocked
Descripción

Nose clear/Nose completely blocked

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0027424
mm
Nose not itchy/Nose extremely itchy
Descripción

Nose not itchy/Nose extremely itchy

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0850060
mm
Nose not sore/Nose as sore as it has ever been
Descripción

Nose not sore/Nose as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0857495
mm
Nose not dry/Nose as dry as it has ever been
Descripción

Nose not dry/Nose as dry as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231919
mm
Throat not sore/Throat as sore as it has ever been
Descripción

Throat not sore/Throat as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0242429
mm
Sense of taste normal/ Sense of taste completely abnormal
Descripción

Sense of taste normal/ Sense of taste completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0039336
mm
Taste nothing/Taste something very strongly
Descripción

Taste nothing/Taste something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1301555
mm
Sense of smell normal/ Sense of smell completely abnormal
Descripción

Sense of smell normal/ Sense of smell completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0037361
mm
Smell nothing/Smell something very strongly
Descripción

Smell nothing/Smell something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C2712084
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231918
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

text

Alias
UMLS CUI [1]
C0231918
Specify symptom
Descripción

Specify symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348235
Visual Analogue Scale - Dosing date/ time (Day 14 - 16)
Descripción

Visual Analogue Scale - Dosing date/ time (Day 14 - 16)

Alias
UMLS CUI-1
C2959685
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
AM Dosing date/ time
Descripción

AM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date/ time
Descripción

PM Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Visual Analogue Scale (Day 14 - 16)
Descripción

Visual Analogue Scale (Day 14 - 16)

Alias
UMLS CUI-1
C2959685
Timepoint
Descripción

Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348792
Date/ Time of assessment
Descripción

Date/ Time of assessment

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Nose not runny/Nose extremely runny
Descripción

Nose not runny/Nose extremely runny

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1260880
mm
Nose clear/Nose completely blocked
Descripción

Nose clear/Nose completely blocked

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0027424
mm
Nose not itchy/Nose extremely itchy
Descripción

Nose not itchy/Nose extremely itchy

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0850060
mm
Nose not sore/Nose as sore as it has ever been
Descripción

Nose not sore/Nose as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0857495
mm
Nose not dry/Nose as dry as it has ever been
Descripción

Nose not dry/Nose as dry as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231919
mm
Throat not sore/Throat as sore as it has ever been
Descripción

Throat not sore/Throat as sore as it has ever been

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0242429
mm
Sense of taste normal/ Sense of taste completely abnormal
Descripción

Sense of taste normal/ Sense of taste completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0039336
mm
Taste nothing/Taste something very strongly
Descripción

Taste nothing/Taste something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1301555
mm
Sense of smell normal/ Sense of smell completely abnormal
Descripción

Sense of smell normal/ Sense of smell completely abnormal

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0037361
mm
Smell nothing/Smell something very strongly
Descripción

Smell nothing/Smell something very strongly

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C2712084
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0231918
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Descripción

Nasal symptom: (No symptoms/Worst symptoms I have ever had)

Tipo de datos

text

Alias
UMLS CUI [1]
C0231918
Specify symptom
Descripción

Specify symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2348235
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Similar models

Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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])
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])
Item Group
Visual Analogue Scale (Period 1 - 5)
C2959685 (UMLS CUI-1)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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)
Item
Please check if not done
text
C1272696 (UMLS CUI [1])
Please check if not done
Code List
Please check if not done
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])
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])
undefined item
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])
Item Group
Visual Analogue Scale (Day 3 - Day 13)
C2959685 (UMLS CUI-1)
Item
Day of assessment
integer
C2985720 (UMLS CUI [1])
Day of assessment
Code List
Day of assessment
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])
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])
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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])
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])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
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])
Item Group
Visual Analogue Scale - Dosing date/ time (Day 14 - 16)
C2959685 (UMLS CUI-1)
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])
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])
Item Group
Visual Analogue Scale (Day 14 - 16)
C2959685 (UMLS CUI-1)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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])
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])
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
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])
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