Phase II Proof of Concept Study in Uncomplicated UTI

Mission Pharmacal

Status and phase: Unknown; Phase 2

Conditions: Urinary Tract Infections

Treatments: Drug: Placebo Oral Tablet; Drug: MPC-SHRC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03129295

MPC-SHRC-002

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

MPC-SHRC

Experimental group

Description:

oral tablet four times a day for 3 days

Treatment:

Drug: MPC-SHRC

Placebo

Placebo Comparator group

Description:

oral tablet four times a day for 3 days

Treatment:

Drug: Placebo Oral Tablet