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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01243125
First received: November 15, 2010
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Urinary Catheter Blockage and Encrustation
Drug: NVC-422, 0.2%
Drug: Sterile normal saline, 0.9%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency

Resource links provided by NLM:


Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Catheter patency following treatment [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter


Secondary Outcome Measures:
  • Incidence of catheter blockage requiring early removal [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Catheters removed prior to completion of treatment regimen will be assessed for each treatment group

  • Assessment of biofilm of catheter [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed

  • Assessment of encrustation of catheter [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed


Enrollment: 67
Study Start Date: November 2010
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVC-422 Drug: NVC-422, 0.2%
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
Other Name: N,N-dichloro-2,2-dimethyltaurine
Placebo Comparator: Saline Drug: Sterile normal saline, 0.9%
Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
Other Name: 0.9% Sodium chloride for injection, USP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243125

Locations
United States, California
Los Amigos Research and Education Institute (LAREI)
Downey, California, United States, 90242
United States, Florida
Specialists in Urology
Naples, Florida, United States, 34102
United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Integrity Medical Research
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
Investigators
Study Director: Kenneth D. Krantz, MD, PhD NovaBay Pharmaceuticals / kkrantz@novabaypharma.com
  More Information

No publications provided

Responsible Party: NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01243125     History of Changes
Other Study ID Numbers: CL1001
Study First Received: November 15, 2010
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NovaBay Pharmaceuticals, Inc.:
Blockage
Encrustation
Catheter
Spinal Cord Injury
SCI

ClinicalTrials.gov processed this record on April 16, 2014