- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129295
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
Conditions
Intervention / Treatment
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
- Name: Hurley Consulting Associates
- Phone Number: 1-908-273-8490
- Email: info@hurleyconsulting.com
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.
Sponsor
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.
Clinical Trials on Urinary Tract Infections
-
GlaxoSmithKlineCompletedInfections, Urinary TractEgypt
-
University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Iterum Therapeutics, International LimitedCompletedComplicated Urinary Tract InfectionsUnited States, Estonia, Hungary, Georgia, Latvia
-
Shandong Branden Med.Device Co.,LtdTerminatedUrinary Tract Infection | Urinary CathetersChina
-
Newcastle-upon-Tyne Hospitals NHS TrustCambridge University Hospitals NHS Foundation Trust; University of Southampton and other collaboratorsCompletedUrinary Tract Infections, RecurrentUnited Kingdom
-
AbbottCompletedUrinary Tract Infections (UTIs)Pakistan
-
Lawson Health Research InstituteCompletedUrinary Tract InfectionCanada
-
National Institute of Diabetes and Digestive and...Completed
-
Inmunotek S.L.CompletedUrinary Tract Infection BacterialSpain, United Kingdom
-
Omri Schwarztuch GildorEnrolling by invitationUrologic Diseases | Urinary Tract DiseaseIsrael
Clinical Trials on MPC-SHRC
-
Myrexis Inc.CompletedBrain NeoplasmsUnited States
-
Myrexis Inc.TerminatedAlzheimer's DiseaseUnited States, Canada
-
The Filatov Institute of Eye Diseases and Tissue...Linkoeping UniversityCompletedCorneal Ulcer | LeukomaUkraine
-
Myrexis Inc.CompletedHIV-1 InfectionUnited States
-
Myriad Therapeutics, Inc.Terminated
-
Myrexis Inc.CompletedRefractory Solid TumorsUnited States
-
Myrexis Inc.Completed
-
L.V. Prasad Eye InstituteLinkoeping UniversityCompleted
-
Myrexis Inc.Completed
-
Columbia UniversityRecruitingNeurodegenerative Diseases | Amyotrophic Lateral Sclerosis | Alzheimer DiseaseUnited States