NCT01519778

A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Detailed description

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Conditions

• Major Cutaneous Abscess
• Cellulitis
• Erysipelas

Interventions

Type	Name	Description
DRUG	TR701 FA	1 tablet 200 mg once daily

Timeline

• Start date: 2012-02-15
• Primary completion: 2012-08-27
• Completion: 2012-08-27
• First posted: 2012-01-27
• Last updated: 2018-08-29
• Results posted: 2015-03-12

Locations

10 sites across 1 country: United States