ID

35419

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 demography form. It has to be filled in for screening.

Lien

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

Mots-clés

Versions (2)
  1. 04/03/2019 04/03/2019 -
  2. 20/09/2021 20/09/2021 -
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

Anglais

Demography

1 Formulaires  
  1. StudyEvent: ODM
    1. Demography
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Protocol Identifier
Description

Protocol Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2826693
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

text

Alias
UMLS CUI [1]
C0079399
If female, record Child-bearing potential
Description

Child-bearing potential

Type de données

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Type de données

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Geographic Ancestry

Alias
UMLS CUI-1
C0034510
African American/African Heritage
Description

African American/African Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Type de données

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Asian - Central/South Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Asian - East Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

Asian - Japanese Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Asian - South East Asian Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Type de données

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - Caucasian/European Heritage
Description

White - Caucasian/European Heritage

Type de données

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demography

1 Formulaires
  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Protocol Identifier
Item
Protocol Identifier
integer
C2826693 (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
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
C0086582 (UMLS CUI-1)
(Comment:en)
CL Item
Female (F)
C0015780 (UMLS CUI-1)
(Comment:en)
Item
If female, record Child-bearing potential
integer
C3831118 (UMLS CUI [1])
Child-bearing potential
Code List
If female, record Child-bearing potential
CL Item
Pre-menarcheal  (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic Ancestry
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White - Caucasian/European Heritage
Item
White - Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Retour au début de la page 

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