NCT01406587

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of 50 mg, 100 mg and 200 mg PP4001 Twice Daily for the Treatment of Burning During Urination, Pain, and Urination Frequency Associated With Uncomplicated Urinary Tract Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Pinnacle Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	PP4001	50 mg, 1 dose every 12 hours x 4 doses
DRUG	PP4001	100 mg, 1 dose every 12 hours x 4 doses
DRUG	PP4001	200 mg, 1 dose every 12 hours x 4 doses
DRUG	Placebo	Placebo, 1 dose every 12 hours x 4 doses

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-08-01
• Last updated: 2011-10-19

Locations

25 sites across 1 country: United States