Clinical Trials Directory

Trials / Completed

CompletedNCT01658020

A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg

Clinical Trials to Evaluate Efficacy and Safety of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg After Multi-dose Oral Administration in Patients With Acute Bacterial Exacerbation of Chronic Obstructive Pulmonary Disease.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
345 (actual)
Sponsor
Dong Wha Pharmaceutical Co. Ltd. · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.

Detailed description

A Phase 3, Multicenter, Double Blind, Active Controlled, Randomized Study to Evaluate the Efficacy and Safety of Zabofloxacin for Patients with acute bacterial exacerbation of Chronic obstructive pulmonary disease.

Conditions

Interventions

TypeNameDescription
DRUGZabofloxacinZabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
DRUGMoxifloxacinMoxifloxacin 400mg tablet P.O. once daily for 7days

Timeline

Start date
2012-08-01
Primary completion
2014-01-01
Completion
2014-08-01
First posted
2012-08-06
Last updated
2014-10-13
Results posted
2014-09-17

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01658020. Inclusion in this directory is not an endorsement.