ID
35418
Beschrijving
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 concomitant medication and Subject product preference form. The concomitant medication has to be filled in if subject use concomitant medications during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00852540
Trefwoorden
Versies (3)
- 04-03-19 04-03-19 -
- 04-03-19 04-03-19 -
- 11-03-19 11-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540
Concomitant medication, Subject product preference
- StudyEvent: ODM
Beschrijving
Prior medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beschrijving
Units
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Taken prior to study
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschrijving
Ongoing of medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Subject medication preference
Alias
- UMLS CUI-1
- C3854006
- UMLS CUI-2
- C0030705
- UMLS CUI-3
- C0558295
Similar models
Concomitant medication, Subject product preference
- StudyEvent: ODM
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0030705 (UMLS CUI-2)
C0558295 (UMLS CUI-3)
C0030705 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,3])