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

Primary Purpose

Chronic Bronchitis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Faropenem medoxomil
placebo
Sponsored by
Replidyne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring bronchitis, AECB

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Multicenter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

faropenem medoxomil

Outcomes

Primary Outcome Measures

• Clinical response at test of cure.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2005
Last Updated
May 30, 2008
Sponsor
Replidyne
Collaborators
INC Research Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00255983
Brief Title
A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
financial reasons
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Replidyne
Collaborators
INC Research Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
bronchitis, AECB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
491 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
faropenem medoxomil
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Faropenem medoxomil
Intervention Description
600 mg BID for 5 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablets BID for 5 days
Primary Outcome Measure Information:
Title
• Clinical response at test of cure.
Time Frame
Day 8 to 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger M Echols, MD
Organizational Affiliation
Replidyne, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Multicenter
City
New Hope
State/Province
Pennsylvania
ZIP/Postal Code
18938
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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