Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
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.