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Phase II Proof of Concept Study in Uncomplicated UTI

Primary Purpose

Urinary Tract Infections

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MPC-SHRC

Placebo Oral Tablet

About this trial

This is an interventional supportive care trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

First Urology PSC
Beyer Research
Lawrence OB/GYN Clinical Research, LLC
Women's Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MPC-SHRC

Placebo

Arm Description

oral tablet four times a day for 3 days

Outcomes

Primary Outcome Measures

Change from baseline on assessment instrument

Patient reported outcome

Secondary Outcome Measures

Change from baseline on assessment instruments

Patient reported outcome

Change from baseline on Pain Scale

Patient reported outcome

Full Information

NCT ID

NCT03129295

First Posted

April 19, 2017

Last Updated

April 21, 2017

Sponsor

Mission Pharmacal

1. Study Identification

Unique Protocol Identification Number

NCT03129295

Brief Title

Phase II Proof of Concept Study in Uncomplicated UTI

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2017 (Anticipated)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mission Pharmacal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MPC-SHRC

Arm Type

Experimental

Arm Description

oral tablet four times a day for 3 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

oral tablet four times a day for 3 days

Intervention Type

Drug

Intervention Name(s)

MPC-SHRC

Intervention Description

Oral tablet four times a day for 3 days

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Oral tablet four times a day for 3 days

Primary Outcome Measure Information:

Title

Change from baseline on assessment instrument

Description

Patient reported outcome

Time Frame

6 hours after the first dose of study drug

Secondary Outcome Measure Information:

Title

Change from baseline on assessment instruments

Description

Patient reported outcome

Time Frame

Three hour intervals after first dose of study drug

Title

Change from baseline on Pain Scale

Description

Patient reported outcome

Time Frame

Three hour intervals after first dose of study drug

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hurley Consulting Associates

Phone

1-908-273-8490

info@hurleyconsulting.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret E. Hurley, MD

Organizational Affiliation

Hurley Consulting Associates Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

First Urology PSC

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

Beyer Research

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Lawrence OB/GYN Clinical Research, LLC

City

Lawrenceville

State/Province

New Jersey

ZIP/Postal Code

08648

Country

United States

Facility Name

Women's Health Research Center

City

Plainsboro

State/Province

New Jersey

ZIP/Postal Code

08536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase II Proof of Concept Study in Uncomplicated UTI

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