A randomized, double‐blind, placebo‐controlled trial to evaluate the efficacy, safety, and tolerability of long‐term treatment with prucalopride

Abstract

This trial did not show statistically significant improvements in primary or secondary outcomes with prucalopride compared with placebo over 24 or 12 weeks. This is in contrast to the results of four previous 12-week trials, which demonstrated prucalopride to be significantly more effective than placebo. An extensive evaluation did not provide an explanation for the null efficacy results of this study.