Phase II Proof of Concept Study in Uncomplicated UTI | NCT03129295

Studies
Phase II Proof of Concept Study in Uncomplicated UTI

NCT03129295

Sponsor

Mission Pharmacal

Status

Unknown status

Last Update Posted

Apr 26, 2017Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Urinary Tract Infections

Interventions

MPC-SHRC
Placebo Oral Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2017Estimated

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Apr 19, 2017

First Submission Date that Met QC Criteria

Apr 21, 2017

First Posted Date

Apr 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MPC-SHRC	Experimental	oral tablet four times a day for 3 days	Drug: MPC-SHRC
Placebo	Placebo Comparator	oral tablet four times a day for 3 days	Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MPC-SHRC	Drug	Oral tablet four times a day for 3 days	MPC-SHRC
Placebo Oral Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline on assessment instrument	Patient reported outcome	6 hours after the first dose of study drug

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline on assessment instruments	Patient reported outcome	Three hour intervals after first dose of study drug
Change from baseline on Pain Scale	Patient reported outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hurley Consulting Associates	Contact	1-908-273-8490		info@hurleyconsulting.com

Overall Officials

Name	Affiliation	Role
Margaret E. Hurley, MD	Hurley Consulting Associates Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Urology PSC		Jeffersonville	Indiana	47130	United States
Beyer Research

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided