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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Exacerbations of Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Prulifloxacin	600 mg/tablet, oral administration of a single tablet.
DRUG	Levofloxacin	500 mg/tablet, oral administration of a tablet daily.
DRUG	Levofloxacin Placebo	Placebo of levofloxacin hydrochloride tablet, without active components.
DRUG	Prulifloxacin placebo	Placebo of prulifloxacin film-coated tablet without active components.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-09-01
• First posted: 2014-06-06
• Last updated: 2014-06-06

Locations

1 site across 1 country: China