NovaBay Pharmaceuticals has initiated a Phase II trial of a compound to prevent urinary catheter blockage and encrustation (UCBE), a major factor behind urinary tract infections.
The multi-centre, randomised, double-blind proof-of-concept trial will compare the use of a catheter irrigation solution containing the compound, NVC-422, against the use of a saline irrigation, the commonly used option for UCBE treatment.
The study will involve subjects with a history of chronic episodes of UCBE.
The trial design is a crossover study in which the patient serves as his or 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 the catheter, and assessment of encrustation of catheter.
NovaBay expects the trial to be completed in the third quarter of 2011 with results available in the fourth quarter. The company has plans to initiate a Phase III registration study for UCBE in 2012.