Phase II Proof of Concept Study in Uncomplicated UTI

Phase 2

• Conditions: Urinary Tract Infections
• Interventions: Drug: MPC-SHRC; Drug: Placebo Oral Tablet

• Registration Number: NCT03129295
• Lead Sponsor: Mission Pharmacal

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Study First Posted: 2017-04-26
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPC-SHRC	MPC-SHRC	oral tablet four times a day for 3 days
Placebo	Placebo Oral Tablet	oral tablet four times a day for 3 days

Primary Outcome Measures

Name	Time	Method
Change from baseline on assessment instrument	6 hours after the first dose of study drug	Patient reported outcome

Secondary Outcome Measures

Name	Time	Method
Change from baseline on assessment instruments	Three hour intervals after first dose of study drug	Patient reported outcome
Change from baseline on Pain Scale	Three hour intervals after first dose of study drug	Patient reported outcome

Trial Locations

Locations (4)

Beyer Research; 🇺🇸 Kalamazoo, Michigan, United States

First Urology PSC; 🇺🇸 Jeffersonville, Indiana, United States

Lawrence OB/GYN Clinical Research, LLC; 🇺🇸 Lawrenceville, New Jersey, United States

Women's Health Research Center; 🇺🇸 Plainsboro, New Jersey, United States