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

Chronic Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00255983
• Other study ID #: REP-FAR-005
• Status: Terminated
• Phase: Phase 3
• First received: November 16, 2005
• Last updated: May 30, 2008
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2008
• Source: Replidyne
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 491
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

Drug:
• Faropenem medoxomil
600 mg BID for 5 days
• placebo
placebo tablets BID for 5 days

Locations

Country	Name	City	State
United States	Multicenter	New Hope	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Replidyne	INC Research Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Clinical response at test of cure.		Day 8 to 12	No