NCT00801021

Treatment and/or Prevention of Urinary Tract Infections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Biomedical Development Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.

Detailed description

A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.

Conditions

• Cystitis
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Frio Mouth Rinse	Rinse with 15ml twice daily then expectorate

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-12-03
• Last updated: 2010-03-08

Locations

1 site across 1 country: United States