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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:
Collaborator:
INC Research Limited
Information provided by:
Replidyne
ClinicalTrials.gov Identifier:
NCT00255983
First received: November 16, 2005
Last updated: May 30, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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
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

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
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, see Learn About Clinical Studies.

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

Keywords provided by Replidyne:
bronchitis
AECB

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

ClinicalTrials.gov processed this record on November 20, 2014