ID

35596

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. In this Subject Diary, please record the following each day: • the date. • the time that topical medication was applied in the morning. • the time oral suspension medication was taken in the morning. • the time the topical medication was applied in the evening. • the time oral suspension medication was taken in the evening. Please use an ink pen and not a pencil. This medical research study depends on you filling in this diary EVERY DAY. Thank you for your/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 you/your child took the study medication. It is very important that you report in this diary the dosing information for each day that you/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. Following your/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.

Lien

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

Mots-clés

Versions (2)

1. 04/03/2019 04/03/2019 -
2. 11/03/2019 11/03/2019 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 mars 2019

DOI

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