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NCT01243125 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
A Phase 2 study of Urinary Catheter Blockage and Encrustation, sponsored by NovaBay Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 8
- Study locations
NCT01243125: Completed Phase 2 study of Urinary Catheter Blockage and Encrustation, sponsored by NovaBay Pharmaceuticals.
NCT01243125 is a Phase 2 study of Urinary Catheter Blockage and Encrustation that has completed, run by NovaBay Pharmaceuticals. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243125, a Phase 2 study of Urinary Catheter Blockage and Encrustation, has completed, sponsored by NovaBay Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter
Conditions Studied
Interventions
- DRUG NVC-422, 0.2%
- DRUG Sterile normal saline, 0.9%
Study Locations (8)
California
- Los Amigos Research and Education Institute (LAREI) - Downey
Florida
- Specialists in Urology - Naples
New Jersey
- Kessler Institute for Rehabilitation - West Orange
North Carolina
- Carolinas Medical Center - Charlotte
Pennsylvania
- Thomas Jefferson University - Philadelphia
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
Virginia
- McGuire Veterans Affairs Medical Center - Richmond
Washington
- Integrity Medical Research - Mountlake Terrace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01243125 record still lists
NCT01243125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Urinary Catheter Blockage and Encrustation appearing as the primary indexed condition, and to 2 interventions - of which NVC-422, 0.2% is the first listed.
NCT01243125 lists 8 locations in 8 states (California, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01243125 about?
NCT01243125 is a clinical study titled "Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation". 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 ...
What is the current status of trial NCT01243125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2010-11. Estimated completion is 2013-08.
What conditions does trial NCT01243125 study?
This clinical trial studies the following conditions: Urinary Catheter Blockage and Encrustation.
What interventions are being tested in trial NCT01243125?
The interventions under investigation include: NVC-422, 0.2% (DRUG), Sterile normal saline, 0.9% (DRUG).
Who is sponsoring clinical trial NCT01243125?
This trial is sponsored by NovaBay Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01243125 being conducted?
This trial has 8 study locations across California, Florida, New Jersey, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01243125's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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