A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis - Full Text View

Sponsors and Collaborators:	Replidyne INC Research Limited
Information provided by:	Replidyne
ClinicalTrials.gov Identifier:	NCT00255983

Purpose

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.

Condition	Intervention	Phase
Chronic Bronchitis	Drug: Faropenem medoxomil Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis

Drug Information available for: Fropenem Faropenem medoxomil

U.S. FDA Resources

Further study details as provided by Replidyne:

Primary Outcome Measures:

• Clinical response at test of cure. [ Time Frame: Day 8 to 12 ] [ Designated as safety issue: No ]

Enrollment:	491
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental faropenem medoxomil	Drug: Faropenem medoxomil 600 mg BID for 5 days
2: Placebo Comparator	Drug: placebo placebo tablets BID for 5 days

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255983

Locations

United States, Pennsylvania
Multicenter
New Hope, Pennsylvania, United States, 18938

Sponsors and Collaborators

Replidyne

INC Research Limited

Investigators

Study Director:

Roger M Echols, MD

Replidyne, Inc.

More Information

No publications provided

Responsible Party:	Replidyne ( Robert Tosiello )
Study ID Numbers:	REP-FAR-005
Study First Received:	November 16, 2005
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00255983 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Replidyne:

bronchitis
AECB

Study placed in the following topic categories:

Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Bronchial Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Acute Disease
Bronchitis, Chronic
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Infections

Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 02, 2009