Urinary Tract InfectionsPhase 2NCT03129295
Phase II Proof of Concept Study in Uncomplicated UTI
A Phase 2 study testing MPC-SHRC in people with Urinary Tract Infections, run by Mission Pharmacal at 4 sites in United States.
Trial summary
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- MPC-SHRC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2017to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
- On adequate birth control
- Normal ECG
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
First Urology PSC
Jeffersonville, Indiana, 47130
Beyer Research
Kalamazoo, Michigan, 49009
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
Women's Health Research Center
Plainsboro, New Jersey, 08536
About this study
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
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
- Conditions
- Urinary Tract Infections
- Being tested
- MPC-SHRC, Placebo Oral Tablet
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPC-SHRCDrug
Oral tablet four times a day for 3 days
Placebo Oral TabletDrug
Oral tablet four times a day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| MPC-SHRC | Experimental | oral tablet four times a day for 3 days Receives: Drug: MPC-SHRC |
| Placebo | Placebo comparator | oral tablet four times a day for 3 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on assessment instrument
Patient reported outcome
Measured: 6 hours after the first dose of study drug
Secondary outcomes (2)
Change from baseline on assessment instruments
Patient reported outcome
Measured: Three hour intervals after first dose of study drug
Change from baseline on Pain Scale
Patient reported outcome
Measured: Three hour intervals after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mission Pharmacal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret E. Hurley, MD, Study director, Hurley Consulting Associates Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129295
- Sponsor's protocol ID
- MPC-SHRC-002
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03129295
- Acronym / sponsor ID
- MPC-SHRC-002
- Conditions
- Urinary Tract Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mission PharmacalIndustry (pharma, biotech, devices)
- Study start
- Apr 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPC-SHRC | Experimental | Drug: MPC-SHRCoral tablet four times a day for 3 days |
| Placebo | Placebo comparator | Drug: Placebo Oral Tabletoral tablet four times a day for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
- On adequate birth control
- Normal ECG
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPC-SHRCOral tablet four times a day for 3 days | Drug | MPC-SHRC |
| Placebo Oral TabletOral tablet four times a day for 3 days | Drug | Placebo |
Primary outcome
Change from baseline on assessment instrument
Time frame: 6 hours after the first dose of study drug
Patient reported outcome
2 secondary outcomes
Change from baseline on assessment instruments
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret E. Hurley, MD study director
Hurley Consulting Associates Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MPC-SHRC in people with Urinary Tract Infections, run by Mission Pharmacal at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hurley Consulting Associates (1-908-273-8490, info@hurleyconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on assessment instrument (time frame: 6 hours after the first dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.