Phase II Proof of Concept Study in Uncomplicated UTI

A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of the Efficacy and Safety of MPC-SHRC for the Relief of Symptoms Associated With Uncomplicated Urinary Tract Infections

A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.

Inclusion Criteria:

• Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
• On adequate birth control
• Normal ECG

Exclusion Criteria:

• Participated in any other trial within 30 days of visit 1
• Known or suspected allergy to investigational drug
• Narrow angle glaucoma
• Recovering from chicken pox or flu-like symptoms
• History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption
• Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections
• Currently taking prohibited drugs
• Taken an antibiotic within 7 days of Visit 1
• Are ineligible to receive an antibiotic
• History of urinary retention
• History of interstitial cystitis
• History of impaired renal function
• History of impaired hepatic function
• Diagnosis or suspicion of complicated urinary tract infection or systemic infection
• History of substance abuse