NCT01128530

Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)

A Randomized, Controlled, Double-Blind, Double Dummy, Multicenter Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Linezolid (Zyvox) for the Treatment of Complicated Skin and Skin Structure Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Furiex Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (cSSSIs).

Conditions

• Complicated Skin and Skin Structure Infections

Interventions

Type	Name	Description
DRUG	JNJ-32729463	250 mg tablet twice daily
DRUG	linezolid	600 mg tablet twice daily
DRUG	JNJ-32729463 placebo	1 placebo tablet twice daily
DRUG	linezolid placebo	1 placebo tablet, twice daily

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-05-24
• Last updated: 2011-12-16

Locations

27 sites across 1 country: United States