Trial | NCT03129295  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cow milk ...

  • Study Participants

    200
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
Study Started
Apr 30
2017
Anticipated
Primary Completion
Sep 30
2017
Anticipated
Study Completion
Sep 30
2017
Anticipated
Last Update
Apr 26
2017

Drug MPC-SHRC

Oral tablet four times a day for 3 days

Drug Placebo Oral Tablet

Oral tablet four times a day for 3 days

MPC-SHRC Experimental

oral tablet four times a day for 3 days

Placebo Placebo Comparator

oral tablet four times a day for 3 days

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
No Results Posted