NCT00255983

A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis

Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Replidyne · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.

Detailed description

This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Faropenem medoxomil	600 mg BID for 5 days
DRUG	placebo	placebo tablets BID for 5 days

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-05-01
• Completion: 2008-06-01
• First posted: 2005-11-21
• Last updated: 2008-06-03

Locations

1 site across 1 country: United States