Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

Summary

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

Timeline

Start

2011-07

Primary completion

2011-10

Completion

2011-10

Drugs

Indications