ID

16056

Descrição

Documentation part: Status of Treatment Bling & Study Conclusion A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline

Palavras-chave

Versões (1)
  1. 27/06/2016 27/06/2016 -
Transferido a

27 de junho de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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Status of Treatment Bling & Study Conclusion Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

Inglês

Status of Treatment Bling & Study Conclusion Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 Formulários  
Status of Treatment Blind (BLIND)
Descrição

Status of Treatment Blind (BLIND)

Was the treatment blind broken during the study?
Descrição

If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate

Tipo de dados

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Descrição

Date blind broken

Tipo de dados

date

Unidades de medida
  • DDMONYYYY
Alias
UMLS CUI [1]
C0011008
DDMONYYYY
Reason blind broken
Descrição

Reason blind broken

Tipo de dados

text

Alias
UMLS CUI [1]
C0392360
If "Other", please specify:
Descrição

If

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
Study Conclusion (CONC)
Descrição

Study Conclusion (CONC)

Date of subject completion or date of subject withdrawal
Descrição

Date of subject completion or date of subject withdrawal

Tipo de dados

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Was the subject withdrawn from the study?
Descrição

Was the subject withdrawn from the study?

Tipo de dados

text

Alias
UMLS CUI [1]
C0422727
If "Yes", select primary reason for withdrawal
Descrição

If "Yes", select primary reason for withdrawal

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0422727
If "other", specify:
Descrição

If "other", specify:

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
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Similar models

Status of Treatment Bling & Study Conclusion Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Status of Treatment Blind (BLIND)
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1])
Was the treatment blind broken during the study?
Code List
Was the treatment blind broken during the study?
CL Item
No (N)
CL Item
Yes (Y)
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1])
Item
Reason blind broken
text
C0392360 (UMLS CUI [1])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
If
Item
If "Other", please specify:
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Study Conclusion (CONC)
Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
If "Yes", select primary reason for withdrawal
text
C0392360 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
If "Yes", select primary reason for withdrawal
Code List
If "Yes", select primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Disease progression (7)
CL Item
Other (OT)
If "other", specify:
Item
If "other", specify:
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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