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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00539994 |
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.
Condition | Intervention | Phase |
---|---|---|
Nasal Colonization With S. Aureus |
Drug: retapamulin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and Efficacy of Retapamulin Ointment, 1% Applied Twice Daily for 3 or 5 Days to the Anterior Nares of Healthy Adult Subjects Nasally Colonized With Staphylococcus Aureus |
Enrollment: | 57 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2008 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female subjects between the ages of 18 and 65, inclusive. A female is eligible to enter and participate in this study if she is non-pregnant, nonlactating and if she is of:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
San Diego, California, United States, 92123 | |
United States, Hawaii | |
GSK Investigational Site | |
Honolulu, Hawaii, United States, 96813 | |
United States, Maryland | |
GSK Investigational Site | |
Baltimore, Maryland, United States, 21225 | |
United States, Washington | |
GSK Investigational Site | |
Tacoma, Washington, United States, 98418 |
Study Director: | GSK Clinical Trials, PharmD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ALB110247 |
Study First Received: | October 4, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00539994 |
Health Authority: | United States: Food and Drug Administration |
retapamulin SB-275833 Altabax safety |
tolerability PK efficacy nasal colonization |
Healthy |