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Phase II Proof of Concept Study in Uncomplicated UTI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03129295
Recruitment Status : Unknown
Verified April 2017 by Mission Pharmacal.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mission Pharmacal

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

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: MPC-SHRC Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MPC-SHRC
oral tablet four times a day for 3 days
Drug: MPC-SHRC
Oral tablet four times a day for 3 days

Placebo Comparator: Placebo
oral tablet four times a day for 3 days
Drug: Placebo Oral Tablet
Oral tablet four times a day for 3 days




Primary Outcome Measures :
  1. Change from baseline on assessment instrument [ Time Frame: 6 hours after the first dose of study drug ]
    Patient reported outcome


Secondary Outcome Measures :
  1. Change from baseline on assessment instruments [ Time Frame: Three hour intervals after first dose of study drug ]
    Patient reported outcome

  2. Change from baseline on Pain Scale [ Time Frame: Three hour intervals after first dose of study drug ]
    Patient reported outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129295


Contacts
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Contact: Hurley Consulting Associates 1-908-273-8490 info@hurleyconsulting.com

Locations
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United States, Indiana
First Urology PSC Not yet recruiting
Jeffersonville, Indiana, United States, 47130
United States, Michigan
Beyer Research Not yet recruiting
Kalamazoo, Michigan, United States, 49009
United States, New Jersey
Lawrence OB/GYN Clinical Research, LLC Not yet recruiting
Lawrenceville, New Jersey, United States, 08648
Women's Health Research Center Not yet recruiting
Plainsboro, New Jersey, United States, 08536
Sponsors and Collaborators
Mission Pharmacal
Investigators
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Study Director: Margaret E. Hurley, MD Hurley Consulting Associates Ltd.

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Responsible Party: Mission Pharmacal
ClinicalTrials.gov Identifier: NCT03129295     History of Changes
Other Study ID Numbers: MPC-SHRC-002
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases