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

NCT01243125 | Completed Phase 2

• 1 other identifier: CL1001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Urinary Catheter Blockage and Encrustation

Keywords

Blockage; Encrustation; Catheter; Spinal Cord Injury; SCI

Outcome Measures

Primary Outcomes (1)

• Catheter patency following treatment

  Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter

  26 days

Secondary Outcomes (3)

• Incidence of catheter blockage requiring early removal

  26 days

• Assessment of biofilm of catheter

  26 days

• Assessment of encrustation of catheter

  26 days

Study Arms (2)

NVC-422

EXPERIMENTAL

Drug: NVC-422, 0.2%

Saline

PLACEBO COMPARATOR

Drug: Sterile normal saline, 0.9%

Interventions

NVC-422, 0.2% DRUG

0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period

Also known as: N,N-dichloro-2,2-dimethyltaurine

NVC-422

Sterile normal saline, 0.9% DRUG

Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period

Also known as: 0.9% Sodium chloride for injection, USP

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
• Screening within 30 days of first treatment

You may not qualify if:

• Systemic antibiotics within 7 days of first treatment
• Investigational drug or device within 30 days of enrollment
• Current infection that requires treatment with systemic antibiotics
• Recent history of significant autonomic dysreflexia (requiring intervention or treatment)

Sponsors & Collaborators

• NovaBay Pharmaceuticals, Inc.: lead

Study Sites (8)

Los Amigos Research and Education Institute (LAREI)

Downey, California, 90242, United States

Location

Specialists in Urology

Naples, Florida, 34102, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Integrity Medical Research

Mountlake Terrace, Washington, 98043, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

NVC-422; Sodium Chloride; Injections

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kenneth D. Krantz, MD, PhD

  NovaBay Pharmaceuticals / kkrantz@novabaypharma.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 18, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (8)