ID

38811

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. 5/11/19 5/11/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de noviembre de 2019

DOI

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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

12-Lead ECG (Period 1 -5; Day 1 - Day 13)

1 formularios  
12-Lead ECG (Period 1 - 5) - Dosing date/time
Descripción

12-Lead ECG (Period 1 - 5) - Dosing date/time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Dosing date/time
Descripción

Dosing date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
12-Lead ECG (Period 1 - 5)
Descripción

12-Lead ECG (Period 1 - 5)

Alias
UMLS CUI-1
C0430456
Timepoint of ECG
Descripción

Timepoint of ECG

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0430456
Date and Time of ECG
Descripción

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Descripción

QTcB Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Day 1 - 13) - Dose
Descripción

12-Lead ECG (Day 1 - 13) - Dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
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
12-Lead ECG (Day 1 - 13)
Descripción

12-Lead ECG (Day 1 - 13)

Alias
UMLS CUI-1
C0430456
Timepont of ECG
Descripción

Timepont of ECG

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0430456
Date and Time of ECG
Descripción

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Descripción

QTcB Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead ECG (Period 1 -5; Day 1 - Day 13)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12-Lead ECG (Period 1 - 5) - Dosing date/time
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
12-Lead ECG (Period 1 - 5)
C0430456 (UMLS CUI-1)
Item
Timepoint of ECG
integer
C2348792 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Timepoint of ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
30 mins (4)
CL Item
1 hr (5)
CL Item
2 hr (6)
CL Item
4 hr (7)
CL Item
8 hr (8)
CL Item
12 hr (9)
CL Item
24 hr (10)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
No result (not available) (3)
Item Group
12-Lead ECG (Day 1 - 13) - Dose
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
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
12-Lead ECG (Day 1 - 13)
C0430456 (UMLS CUI-1)
Item
Timepont of ECG
integer
C2348792 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Timepont of ECG
Code List
Timepont of ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
pre-dose 3 (3)
CL Item
30 mins (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:30 mins (9)
CL Item
14 hr (10)
CL Item
16 hr / not done option (11)
CL Item
20 hr / not done option (12)
CL Item
24 hr (Day 2) (13)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
No result (not available) (3)
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