Phase II Proof of Concept Study in Uncomplicated UTI

NCT03129295 — Phase 2, Unknown, 200 participants, Mission Pharmacal

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03129295
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	200 (Estimated)
Sponsor	Mission Pharmacal (Industry)
Conditions	Urinary Tract Infections
Interventions	MPC-SHRC, Placebo Oral Tablet (Drug)
Dates	start 2017-04-01 (estimated), primary completion 2017-09-01 (estimated), completion 2017-09-01 (estimated), first posted 2017-04-26, last updated 2017-04-26
Locations	4 sites in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
MPC-SHRC	Experimental	Drug: MPC-SHRC	oral tablet four times a day for 3 days
Placebo	Placebo comparator	Drug: Placebo Oral Tablet	oral tablet four times a day for 3 days

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

+Outcome measures

Primary outcomes

Change from baseline on assessment instrument [6 hours after the first dose of study drug]: Patient reported outcome

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
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

+Investigators

Margaret E. Hurley, MD, Study director, Hurley Consulting Associates Ltd.

My Notes

Public

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