Phase II Proof of Concept Study in Uncomplicated UTI

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03129295

Enrollment

200

Registered

2017-04-26

Start date

2017-04-30

Completion date

2017-09-30

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Brief summary

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

Interventions

DRUGMPC-SHRC

Oral tablet four times a day for 3 days

DRUGPlacebo Oral Tablet

Oral tablet four times a day for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactHurley Consulting Associates

info@hurleyconsulting.com1-908-273-8490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026