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Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

NCT01406587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2011-10-19

No results posted yet for this study

Summary

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

Conditions

Interventions

DRUG

PP4001

50 mg, 1 dose every 12 hours x 4 doses

DRUG

PP4001

100 mg, 1 dose every 12 hours x 4 doses

DRUG

PP4001

200 mg, 1 dose every 12 hours x 4 doses

DRUG

Placebo

Placebo, 1 dose every 12 hours x 4 doses

Sponsors & Collaborators

  • Pinnacle Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Suma Krishnan · Pinnacle Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406587 on ClinicalTrials.gov