NCT00539994

Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics (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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	retapamulin	200mg BID retapamulin 3 days
DRUG	Retapamulin	200mg BID retapamulin 5 days
DRUG	Placebo	200mg BID placebo 5 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-10-05
• Last updated: 2016-12-15
• Results posted: 2010-08-20

Locations

4 sites across 1 country: United States