NCT02439632

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese

Conditions

• Acute Lower Urinary Tract Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2015-05-12
• Last updated: 2015-07-16

Locations

1 site across 1 country: China