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

This study has been terminated.
(financial reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255983
First Posted: November 21, 2005
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
INC Research Limited
Information provided by:
Replidyne
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Replidyne:

Primary Outcome Measures:
  • • Clinical response at test of cure. [ Time Frame: Day 8 to 12 ]

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
Experimental: 1
faropenem medoxomil
Drug: Faropenem medoxomil
600 mg BID for 5 days
Placebo Comparator: 2 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robert Tosiello, Replidyne
ClinicalTrials.gov Identifier: NCT00255983     History of Changes
Other Study ID Numbers: REP-FAR-005
First Submitted: November 16, 2005
First Posted: November 21, 2005
Last Update Posted: June 3, 2008
Last Verified: May 2008

Keywords provided by Replidyne:
bronchitis
AECB

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents