ID

35415

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 Log status form. It has to be filled in for the end of study.

Lien

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

Mots-clés

  1. 04/03/2019 04/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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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

  1. StudyEvent: ODM
    1. Log status
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Log status
Description

Log status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

Concomitant medications

Type de données

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious AE

Type de données

text

Alias
UMLS CUI [1]
C1518404
Did the subject experience a serious adverse event during the study?
Description

Serious adverse event

Type de données

text

Alias
UMLS CUI [1]
C1519255

Similar models

Log status

  1. StudyEvent: ODM
    1. Log status
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Log status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience a serious adverse event during the study?
CL Item
No (N)
CL Item
Yes (Y)

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