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Phase II Proof of Concept Study in Uncomplicated UTI

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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

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date April 26, 2017
Estimated Study Start Date  ICMJE April 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Change from baseline on assessment instrument [ Time Frame: 6 hours after the first dose of study drug ]
Patient reported outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Change from baseline on assessment instruments [ Time Frame: Three hour intervals after first dose of study drug ]
    Patient reported outcome
  • Change from baseline on Pain Scale [ Time Frame: Three hour intervals after first dose of study drug ]
    Patient reported outcome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Proof of Concept Study in Uncomplicated UTI
Official Title  ICMJE 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
Brief Summary A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MPC-SHRC
    oral tablet four times a day for 3 days
    Intervention: Drug: MPC-SHRC
  • Placebo Comparator: Placebo
    oral tablet four times a day for 3 days
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 21, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03129295
Other Study ID Numbers  ICMJE MPC-SHRC-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mission Pharmacal
Study Sponsor  ICMJE Mission Pharmacal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Margaret E. Hurley, MD Hurley Consulting Associates Ltd.
PRS Account Mission Pharmacal
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP