ID

38810

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)
  1. 05/11/2019 05/11/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 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

Inglês

Investigational Product (Period 1 - 5; Day 1 - Day 16)

1 Formulários  
Investigational Product (Dose) (Period 1 - 5)
Descrição

Investigational Product (Dose) (Period 1 - 5)

Date/ time of dose
Descrição

Date/ time of dose

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
Number of Actuations
Descrição

Number of Actuations

Tipo de dados

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descrição

Did the subject receive the correct treatment during this dosing interval?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Descrição

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Dose) (Day 1 - 13)
Descrição

Investigational Product (Dose) (Day 1 - 13)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Dose Timepoint
Descrição

Dose Timepoint

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2348792
Start date/time of dose
Descrição

Start date/time of dose

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Descrição

Number of Actuations

Tipo de dados

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descrição

Did the subject receive the correct treatment during this dosing interval?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Descrição

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Day 3 - Day 13 Dose)
Descrição

Investigational Product (Day 3 - Day 13 Dose)

Alias
UMLS CUI-1
C0304229
Dose Timepoint
Descrição

Dose Timepoint

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C2348792
Start date/time of dose
Descrição

Start date/time of dose

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Descrição

Number of Actuations

Tipo de dados

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descrição

Did the subject receive the correct treatment during this dosing interval?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Descrição

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Dose) (Day 14 - 16)
Descrição

Investigational Product (Dose) (Day 14 - 16)

Alias
UMLS CUI-1
C0304229
Dose Timepoint
Descrição

Dose Timepoint

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C2348792
Start date/time of dose
Descrição

Start date/time of dose

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Descrição

Number of Actuations

Tipo de dados

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descrição

Did the subject receive the correct treatment during this dosing interval?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Descrição

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
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Similar models

Investigational Product (Period 1 - 5; Day 1 - Day 16)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Investigational Product (Dose) (Period 1 - 5)
Date/ time of dose
Item
Date/ time of dose
datetime
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose) (Day 1 - 13)
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Dose Timepoint
integer
C0178602 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Dose Timepoint
Code List
Dose Timepoint
CL Item
Day 1 AM dose (1)
CL Item
Day 1 PM dose (2)
CL Item
Day 2 AM dose (3)
CL Item
Day 2 PM dose (4)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Day 3 - Day 13 Dose)
C0304229 (UMLS CUI-1)
Item
Dose Timepoint
integer
C2348792 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint
Code List
Dose Timepoint
CL Item
Day 3 AM (1)
CL Item
Day 3 PM (2)
CL Item
Day 4 AM (3)
CL Item
Day 4 PM (4)
CL Item
Day 5 AM (5)
CL Item
Day 5 PM (6)
CL Item
Day 6 AM (7)
CL Item
Day 6 PM (8)
CL Item
Day 7 AM (9)
CL Item
Day 7 PM (10)
CL Item
Day 8 AM (11)
CL Item
Day 8 PM (12)
CL Item
Day 9 AM (13)
CL Item
Day 9 PM (14)
CL Item
Day 10 AM (15)
CL Item
Day 10 PM (16)
CL Item
Day 11 AM (17)
CL Item
Day 11PM (18)
CL Item
Day 12 AM (19)
CL Item
Day 12 PM (20)
CL Item
Day 13 AM (21)
CL Item
Day 13 PM (22)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose) (Day 14 - 16)
C0304229 (UMLS CUI-1)
Item
Dose Timepoint
integer
C2348792 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Dose Timepoint
Code List
Dose Timepoint
CL Item
Day 14 AM dose (1)
CL Item
Day 14 PM dose (2)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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