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 Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control

PHASE3CompletedINTERVENTIONAL

Enrollment

216

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

July 31, 2015

Conditions

Acute Lower Urinary Tract Infection

Interventions

DRUG

prulifloxacin

DRUG

Levofloxacin

Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.

DRUG

Prulifloxacin Placebo

Placebo of prulifloxacin film-coated tablet without active components.

DRUG

Levofloxacin Placebo

Placebo of levofloxacin hydrochloride tablet without active components.

Trial Locations (1)

Peking Medical Union Hospital, Beijing