ID

35421

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 subject diary (For subjects 5-11 years of age; <5 years of age; >=12 years of age) form. It has to be filled in for the end of study.

Link

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

Keywords

Versions (2)
  1. 3/4/19 3/4/19 -
  2. 3/11/19 3/11/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 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

English

Subject Diary

1 forms  
  1. StudyEvent: ODM
    1. Subject Diary
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject diary instruction
Description

Subject diary instruction

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C1442085
Contact person
Description

This medical research study depends on you filling in this diary EVERY DAY. Thank you for your child’s participation in this clinical research study. As part of this study, we are asking that, each day, you record in this "Subject Diary" information about how your child took the study medication. It is very important that you report in this diary the dosing information for each day that your child took study medication. Please bring this diary with you to each of your appointments, until the diary is collected by the study site staff. Should you have any questions about the study medication prior to your next appointment, please contact your study coordinator (see below). Following your child’s treatment, please return ALL medication tubes and bottles to the study coordinator who gave you the study medication. Thank you very much for your help.

Data type

text

Alias
UMLS CUI [1]
C0337611
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Study medication
Description

Study medication

Data type

integer

Alias
UMLS CUI [1]
C0013227
Day of medication
Description

Day of medication

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439228
Date of medication
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Time of Morning Dose
Description

24-hr clock

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0332170
Time of Evening Dose
Description

24-hr clock

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0587117
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Similar models

Subject Diary

1 forms
  1. StudyEvent: ODM
    1. Subject Diary
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])
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Subject diary instruction
C3890583 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Contact person
Item
Contact person
text
C0337611 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Item
Study medication
integer
C0013227 (UMLS CUI [1])
Study medication
Code List
Study medication
CL Item
Topical Medication (1)
CL Item
Oral suspension Medication (2)
Item
Day of medication
integer
C0013227 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day of medication
Code List
Day of medication
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4  (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Date of medication
Item
Date of medication
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Morning Dose
Item
Time of Morning Dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Time of Evening Dose
Item
Time of Evening Dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
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