Phase II Proof of Concept Study in Uncomplicated UTI

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03129295
• Other study ID #: MPC-SHRC-002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 19, 2017
• Last updated: April 21, 2017
• Start date: April 2017
• Est. completion date: September 2017

Study information

• Verified date: April 2017
• Source: Mission Pharmacal
• Contact: Hurley Consulting Associates
• Phone: 1-908-273-8490
• Email: info[@]hurleyconsulting.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections

Intervention

Drug:
• MPC-SHRC
Oral tablet four times a day for 3 days
• Placebo Oral Tablet
Oral tablet four times a day for 3 days

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Mission Pharmacal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on assessment instrument	Patient reported outcome	6 hours after the first dose of study drug
Secondary	Change from baseline on assessment instruments	Patient reported outcome	Three hour intervals after first dose of study drug
Secondary	Change from baseline on Pain Scale	Patient reported outcome	Three hour intervals after first dose of study drug