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Anti-microbial

Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation

Phase 2
Waitlist Available
Research Sponsored by NovaBay Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 days

Summary

NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others. The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life. The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage. Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Catheter patency following treatment
Secondary study objectives
Assessment of biofilm of catheter
Assessment of encrustation of catheter
Incidence of catheter blockage requiring early removal

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NVC-422Experimental Treatment1 Intervention
Group II: SalinePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auriclosene
Not yet FDA approved

Find a Location

Who is running the clinical trial?

NovaBay Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,459 Total Patients Enrolled
1 Trials studying Urinary Catheter Blockage and Encrustation
140 Patients Enrolled for Urinary Catheter Blockage and Encrustation
Kenneth D. Krantz, MD, PhDStudy DirectorNovaBay Pharmaceuticals / kkrantz@novabaypharma.com
1 Previous Clinical Trials
129 Total Patients Enrolled
~4 spots leftby Jan 2026