ID

35534

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 Randomisation and Investigational product container Number form. It has to be filled in for screening.

Link

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

Keywords

  1. 3/4/19 3/4/19 -
  2. 3/7/19 3/7/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 7, 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

Randomisation Investigational product container Number

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Randomisation

Data type

text

Alias
UMLS CUI [1]
C0034656
If subject was able to be randomised, note randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
If subject was able to be randomised, note Date of randomisation
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational product container Number
Description

Investigational product container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational product container Number for topical study drug
Description

Investigational product container Number for topical study drug

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [1,4]
C0332237
Investigational product container Number for oral study drug
Description

Investigational product container Number for oral study drug

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [1,4]
C0442027

Similar models

Randomisation Investigational product container Number

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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1])
Code List
Was the subject able to be randomised?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation Number
Item
If subject was able to be randomised, note randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
If subject was able to be randomised, note Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational product container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational product container Number for topical study drug
Item
Investigational product container Number for topical study drug
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0332237 (UMLS CUI [1,4])
Investigational product container Number for oral study drug
Item
Investigational product container Number for oral study drug
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])

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