ID

35673

Description

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Study conclusion, investigational product, status of treatment blind, pregnancy information and Subject product preference form. It has to be filled in for the end of study.

Link

https://clinicaltrials.gov/ct2/show/NCT00852540

Keywords

Versions (3)
  1. 3/4/19 3/4/19 -
  2. 3/11/19 3/11/19 -
  3. 3/15/19 3/15/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540

English

Study conclusion, investigational product, status of treatment blind, pregnancy information, Subject product preference

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Study conclusion
Description

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
UMLS CUI [2]
C1549507
Was the subject withdrawn from the study?
Description

Withdrawl

Data type

text

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from the study, complete primary reason for withdrawal
Description

Select "Investigator discretion" and "Withdrew consent" if none of the other primary reasons are appropriate.

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
If Subject reached protocol defined stopping criteria: Pregnancy?
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
If Reason for withdrawal was Investigator discretion, specify.
Description

Complete this item, if you ticked "Investigator discretion" as primary reason for withdrawal.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
If Reason for withdrawal was "Withdrew consent", specify
Description

Complete this item, if you ticked "Withdrew consent" as primary reason for withdrawal.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1707492
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
Investigational product
Description

Investigational product

Data type

integer

Alias
UMLS CUI [1]
C0304229
Date of first Dose
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C3173309
Time of first Dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0040223
Date of last Dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of last Dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Total number of applications
Description

For topical study drug only.

Data type

integer

Alias
UMLS CUI [1,1]
C0185125
UMLS CUI [1,2]
C0449788
Total number of doses
Description

For oral study drug only.

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0750480
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 Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

Data type

text

Alias
UMLS CUI [1]
C3897431
Date blind broken
Description

day month year. Complete if treatment blind was broken during the study.

Data type

date

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

Complete if treatment blind was broken during the study.

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
If other reason blind broken, please specify
Description

Other reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0566251
Pregnancy information
Description

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete the paper Pregnancy Notification form

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Subject medication preference
Description

Subject medication preference

Alias
UMLS CUI-1
C3854006
UMLS CUI-2
C0030705
UMLS CUI-3
C0558295
Subject product preference
Description

Subject product preference

Data type

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0558295
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Similar models

Study conclusion, investigational product, status of treatment blind, pregnancy information, Subject product preference

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Withdrawl
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
If subject was withdrawn from the study, complete primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
If subject was withdrawn from the study, complete primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol-defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Pregnancy
Item
If Subject reached protocol defined stopping criteria: Pregnancy?
boolean
C0032961 (UMLS CUI [1])
Reason for withdrawal: Investigator discretion
Item
If Reason for withdrawal was Investigator discretion, specify.
text
C0422727 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Reason for withdrawal: Withdrew consent
Item
If Reason for withdrawal was "Withdrew consent", specify
text
C0422727 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Item
Investigational product
integer
C0304229 (UMLS CUI [1])
Investigational product
Code List
Investigational product
CL Item
Topical study drug (1)
CL Item
Oral study drug (2)
Date of first Dose
Item
Date of first Dose
date
C3173309 (UMLS CUI [1])
Time of first Dose
Item
Time of first Dose
time
C0304229 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Date of last Dose
Item
Date of last Dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of last Dose
Item
Time of last Dose
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Total number of applications
Item
Total number of applications
integer
C0185125 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Total number of doses
Item
Total number of doses
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
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
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Progressive disease (2)
CL Item
Other (3)
Other reason blind broken
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Subject medication preference
C3854006 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
Item
Subject product preference
integer
C3854006 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,3])
Subject product preference
Code List
Subject product preference
CL Item
Prefer oral medication (1)
CL Item
Prefer topical medication (2)
CL Item
No preference (3)
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