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NCT02130518
A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
Phase 2 trial testing Auriclosene Irrigation Solution, 0.2% in Urinary Catheter Blockage and Encrustation in 140 participants. Status unknown.
1 December 2015
Quick facts
| Lead sponsor | NovaBay Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 1 September 2014 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 January 2016 |
| Sites | 17 locations across United States |
Drugs / interventions tested
- Auriclosene Irrigation Solution, 0.2% — full drug profile →
- Auriclosene Vehicle Solution
Conditions studied
- Urinary Catheter Blockage and Encrustation — all drugs for Urinary Catheter Blockage and Encrustation →
Sponsor
NovaBay Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Urinary Catheter Blockage and Encrustation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percent flow rate reduction of study catheters at time of removal
Time frame: Up to 29 Days
Sponsor's own description
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur. 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. Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis. Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Washout policies in long-term indwelling urinary catheterisation in adults.
Shepherd AJ, Mackay WG, Hagen S. · · 2017 · cited 23× · PMID 28262925 · DOI 10.1002/14651858.cd004012.pub5
Verify or expand the search:
- PubMed search for NCT02130518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02130518 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NovaBay Pharmaceuticals, Inc.
- Last refreshed: 30 November 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02130518.
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