ID

35534

Beskrivning

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.

Länk

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

Nyckelord

  1. 2019-03-04 2019-03-04 -
  2. 2019-03-07 2019-03-07 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 mars 2019

DOI

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Licens

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
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Beskrivning

Randomisation Number

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

Randomisation

Datatyp

text

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

Randomisation Number

Datatyp

text

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

day month year

Datatyp

date

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

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
Beskrivning

Investigational product container Number for topical study drug

Datatyp

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
Beskrivning

Investigational product container Number for oral study drug

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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