Prostatitis Treatment examine the effect of a peripherally active fatty acid amide hydrolase (FAAH-) inhibitor ASP3652 on safety and efficacy outcomes in Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). Inhibition of FAAH is hypothesized to reduce the excitability of urinary tract afferents including nociceptors.
In this adaptive, randomized, double-blind, placebo-controlled study adult male patients with moderate to severe CP/CPPS were treated for 12 weeks with an oral dose of ASP3652 (25, 75, 150 or 300mg twice daily [BID], or 300mg once daily) or placebo. A Bayesian model was used for adaptive prospective modeling of randomization, study continuation decisions and analysis of the efficacy variables Chronic Pelvic Pain Syndrome .
The study was stopped for futility at pre-planned interim analysis when 239 patients were randomized (226 were included in the intention-to-treat set): the 25mg group showed the largest reduction of the primary endpoint NIH-CPSI total score (7.0 points), Chronic Prostatitis but the placebo group showed a mean reduction of 7.3 points (difference: 0.3 [95% confidence interval: -1.9 to 2.6]). Micturition outcomes improved compared to placebo in all ASP3652 groups, e.g., in the 300mg bis in die (BID, twice daily) group voiding frequency decreased by -1.10 (95% CI -2.0 to -0.2) voids/24hr vs. placebo. Safety outcomes were comparable across the treatment groups.
ASP3652 was generally safe and well-tolerated. It did not show efficacy on pain symptoms in patients with CP/CPPS. However, BPH results indicate that FAAH-inhibition may attenuate lower urinary tract symptoms. Dedicated studies in patients with lower urinary tract dysfunction are needed to confirm this.
By . Prostatitis
Prostatitis Symptoms :
Blood in the semen
Blood in the Urine
Burning While Urinating
Pain While Urinating