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news.NovaBay Pharmaceuticals has initiated a Phase II trial of NVC-422, a compound used to prevent urinary catheter blockage and encrustation (UCBE), a major factor behind urinary tract infections.
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The multi-centre, randomised, double-blind proof-of-concept clinical trial will compare the use of a catheter irrigation solution containing NVC-422 versus the use of a saline irrigation, the commonly used option for UCBE treatment.
The study will involve subjects have a history of chronic episodes of UCBE.
The trial design is a crossover study in which the patient serves as his/her own control, where patients will receive either NVC-422 or saline solution followed by a treatment with the other solution.
The primary outcome measures include catheter patency following treatment, while secondary outcome measures include incidence of catheter blockage requiring early removal, assessment of biofilm of catheter, and assessment of encrustation of catheter.
NovaBay expects the trial to be completed in Q3 2011 with results available in Q4 2011, and plans to initiate a Phase III registration study for UCBE in 2012.