ID

35415

Beschreibung

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.

Link

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

Stichworte

  1. 04.03.19 04.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. März 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Log status

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

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Log status
Beschreibung

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?
Beschreibung

Concomitant medications

Datentyp

text

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

Non-serious AE

Datentyp

text

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

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255

Ähnliche Modelle

Log status

  1. StudyEvent: ODM
    1. Log status
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video