Phase II Proof of Concept Study in Uncomplicated UTI

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infections

In brief

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

Key facts

Study ID

NCT03129295

Run by

Mission Pharmacal

People needed

200

Starts

2017-04-01

Expected to finish

2017-09-01

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• First Urology PSC — Jeffersonville, Indiana, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Lawrence OB/GYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• Women's Health Research Center — Plainsboro, New Jersey, United States

Full record on ClinicalTrials.gov

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