Status:
COMPLETED
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
Lead Sponsor:
NovaBay Pharmaceuticals, Inc.
Conditions:
Urinary Catheter Blockage and Encrustation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01243125
Start Date
November 1 2010
End Date
August 1 2013
Last Update
August 7 2014
Active Locations (8)
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1
Los Amigos Research and Education Institute (LAREI)
Downey, California, United States, 90242
2
Specialists in Urology
Naples, Florida, United States, 34102
3
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
4
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203