BioXell fully enrolled for bladder drug trial

Italy's BioXell has completed enrollment for a Phase IIb trial of its lead compound elocalcitol in overactive bladder.

The urodynamic, multicenter, double-blind, placebo controlled study has recruited 257 patients who have been randomized into three groups, placebo, 75mcg and 150mcg, and treated daily for four weeks. The primary endpoint is to evaluate the effect of elocalcitol on bladder volume at the first involuntary detrusor contraction. Secondary endpoints include additional urodynamic parameters, symptoms severity and patient's perception of bladder condition. Preliminary results are expected in the second quarter of 2009.

"Compared to clinical trials based on subjective criteria only, urodynamic studies allow the reduction of the usually high placebo response shown in patients with detrusor overactivity," said chief executive Francesco Sinigaglia.