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

Phase 3

Terminated

• Conditions: Chronic Bronchitis
• Interventions: Drug: placebo; Drug: Faropenem medoxomil

• Registration Number: NCT00255983
• Lead Sponsor: Replidyne

Brief 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.

Study Timeline

• Study First Submitted: 2005-11-16
• Study First Submitted QC: 2005-11-16
• Study First Posted: 2005-11-21
• Study Start: 2005-12
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Last Update Submitted: 2008-05-30
• Study Completion: 2008-06
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

• Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation

Exclusion Criteria

• Gold criteria III

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	Faropenem medoxomil	faropenem medoxomil

Primary Outcome Measures

Name	Time	Method
• Clinical response at test of cure.	Day 8 to 12

Trial Locations

Locations (1)

Multicenter; 🇺🇸 New Hope, Pennsylvania, United States