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

NCT02439632 Phase 3 COMPLETED

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

Details

Lead sponsor	Lee's Pharmaceutical Limited
Phase	Phase 3
Status	COMPLETED
Enrolment	216
Start date	2014-02
Completion	2015-07

Conditions

• Acute Lower Urinary Tract Infection

Interventions

• prulifloxacin
• Levofloxacin
• Prulifloxacin Placebo
• Levofloxacin Placebo

Primary outcomes

• The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured — 3 days
  600mg single dose prolifloxacin is not inferior to Levoflxacin on low urine infection in Chinese

Countries

China