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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00539994 |
Purpose
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 |
|---|---|---|
|
Infections, Bacterial |
Drug: retapamulin Drug: Retapamulin Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment B
200mg BID retapamulin 5 days
|
Drug: Retapamulin
200mg BID retapamulin 5 days
|
|
Placebo Comparator: Treatment C
200mg BID placebo 5 days
|
Drug: Placebo
200mg BID placebo 5 days
|
|
Experimental: Treatment A
200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days
|
Drug: retapamulin
200mg BID retapamulin 3 days
|
Eligibility| 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:
Contacts and Locations| 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 | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00539994 History of Changes |
| Other Study ID Numbers: | ALB110247 |
| Study First Received: | October 4, 2007 |
| Results First Received: | January 9, 2009 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Altabax SB-275833 retapamulin nasal colonization |
PK tolerability safety efficacy |
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Bacterial Infections |