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
1 other identifier
interventional
200
1 country
4
Brief Summary
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2017
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedApril 26, 2017
April 1, 2017
5 months
April 19, 2017
April 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline on assessment instrument
Patient reported outcome
6 hours after the first dose of study drug
Secondary Outcomes (2)
Change from baseline on assessment instruments
Three hour intervals after first dose of study drug
Change from baseline on Pain Scale
Three hour intervals after first dose of study drug
Study Arms (2)
MPC-SHRC
EXPERIMENTALoral tablet four times a day for 3 days
Placebo
PLACEBO COMPARATORoral tablet four times a day for 3 days
Interventions
Eligibility Criteria
You may qualify if:
- Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
- On adequate birth control
- Normal ECG
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
First Urology PSC
Jeffersonville, Indiana, 47130, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
Women's Health Research Center
Plainsboro, New Jersey, 08536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Margaret E. Hurley, MD
Hurley Consulting Associates Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 26, 2017
Study Start
April 1, 2017
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
April 26, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share