ID

16056

Description

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

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

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

English

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

1 forms  
Status of Treatment Blind (BLIND)
Description

Status of Treatment Blind (BLIND)

Was the treatment blind broken during the study?
Description

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

Data type

text

Alias
UMLS CUI [1]
C2347038
Date blind broken
Description

Date blind broken

Data type

date

Measurement units
  • DDMONYYYY
Alias
UMLS CUI [1]
C0011008
DDMONYYYY
Reason blind broken
Description

Reason blind broken

Data type

text

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

If

Data type

text

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

Study Conclusion (CONC)

Date of subject completion or date of subject withdrawal
Description

Date of subject completion or date of subject withdrawal

Data type

date

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Was the subject withdrawn from the study?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

Was the subject withdrawn from the study?

Data type

text

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

If "Yes", select primary reason for withdrawal

Data type

text

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

If "other", specify:

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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