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

PHASE3UnknownINTERVENTIONAL

Enrollment

360

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

September 30, 2014

Conditions

Acute Exacerbations of Chronic Bronchitis

Interventions

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.

Trial Locations (1)

RECRUITING

Nei Mongo medical University, Nei Mongo