Phase II Proof of Concept Study in Uncomplicated UTI

April 21, 2017 updated by: Mission Pharmacal

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.

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • First Urology PSC
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB/GYN Clinical Research, LLC
      • Plainsboro, New Jersey, United States, 08536
        • Women's Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPC-SHRC
oral tablet four times a day for 3 days
Oral tablet four times a day for 3 days
Placebo Comparator: Placebo
oral tablet four times a day for 3 days
Oral tablet four times a day for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on assessment instrument
Time Frame: 6 hours after the first dose of study drug
Patient reported outcome
6 hours after the first dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on assessment instruments
Time Frame: Three hour intervals after first dose of study drug
Patient reported outcome
Three hour intervals after first dose of study drug
Change from baseline on Pain Scale
Time Frame: Three hour intervals after first dose of study drug
Patient reported outcome
Three hour intervals after first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Margaret E. Hurley, MD, Hurley Consulting Associates Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-SHRC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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