ID

41257

Description

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)

Mots-clés

  1. 28/07/2020 28/07/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

28 juillet 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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

Status of Treatment Blind

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

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

Status of Treatment Blind

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

If yes, complete the following

Type de données

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Description

Date blind broken

Type de données

date

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

Time blind broken

Type de données

time

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

Check one

Type de données

integer

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

If other reason for blind broken, specify

Type de données

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)
Type de données
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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