drugset / Trial / NCT02157571

A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control

NCT02157571

Phase 3 Unknown 360 enrolled Lee's Pharmaceutical Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.

Timeline

Start
2013-06
Primary completion
2014-06
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levofloxacin Small molecule 500 mg Oral
Subject Prulifloxacin Small molecule 600 mg Oral

Indications