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Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients

NCT00781339 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-09-12

No results posted yet for this study

Summary

The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.

Conditions

  • Asymptomatic Bacteriuria

Interventions

DRUG

sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

0.1% NVC-422 in saline, up to 100 mL, Study Part 1 - once on Day 1 held in the bladder for 1 hour; Study Part 2 (Part 2a - 0.1% NVC-422, Part 2b - 0.2% NVC-422), once daily for 7 days, held in the bladder for 1 hour

Sponsors & Collaborators

  • NovaBay Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Rabih O. Darouiche, M.D. · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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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 NCT00781339 on ClinicalTrials.gov