ID

41257

Beschrijving

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Trefwoorden

  1. 28-07-20 28-07-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

28 juli 2020

DOI

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Licentie

Creative Commons BY 4.0

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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Status of Treatment Blind

Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Status of Treatment Blind
Beschrijving

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschrijving

If yes, complete the following

Datatype

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Beschrijving

Date blind broken

Datatype

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Beschrijving

Time blind broken

Datatype

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Beschrijving

Check one

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason for blind broken, specify
Beschrijving

If other reason for blind broken, specify

Datatype

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235

Similar models

Status of Treatment Blind

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
If other reason for blind broken, specify
Item
If other reason for blind broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])

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