Status:
TERMINATED
A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
Lead Sponsor:
Replidyne
Collaborating Sponsors:
INC Research Limited
Conditions:
Chronic Bronchitis
Eligibility:
All Genders
35+ years
Phase:
PHASE3
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 ha...
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 tr...
Eligibility Criteria
Inclusion
- 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
- Gold criteria III
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT00255983
Start Date
December 1 2005
End Date
June 1 2008
Last Update
June 3 2008
Active Locations (1)
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1
Multicenter
New Hope, Pennsylvania, United States, 18938