NCT00255983

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

November 16, 2005

Last Update Submit

May 30, 2008

Conditions

Chronic Bronchitis

Keywords

bronchitisAECB

Outcome Measures

Primary Outcomes (1)

  • • Clinical response at test of cure.

    Day 8 to 12

Study Arms (2)

1

EXPERIMENTAL

faropenem medoxomil

Drug: Faropenem medoxomil

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

Faropenem medoxomilDRUG

600 mg BID for 5 days

1
placeboDRUG

placebo tablets BID for 5 days

2

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Gold criteria III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multicenter

New Hope, Pennsylvania, 18938, United States

Location

MeSH Terms

Conditions

Bronchitis, ChronicBronchitis

Interventions

faropenem medoxomil

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roger M Echols, MD

    Replidyne, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

December 1, 2005

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

US(1)