Salix Initiates Phase III Irritable Bowel Syndrome Trial

Posted on: Tuesday, 1 July 2008, 06:00 CDT Salix Pharmaceuticals has initiated patient enrollment in Target 1 and Target 2, its Phase III, randomized, double-blind, placebo-controlled, multicenter studies to assess the efficacy and safety of rifaximin 550mg, dosed three times daily, in the treatment of subjects with non-constipation irritable bowel syndrome. According to the company, two 600-subject trials will be conducted simultaneously in approximately 180 study centers throughout the US and Canada. Subjects will receive rifaximin or placebo (1:1 randomization) for 14 days and then be followed for 10 weeks for a study duration of 12 weeks. Target 1 and Target 2 are intended to assess the clinical efficacy and safety of a 550mg TID dosing regimen of rifaximin (1,650mg/day) compared with placebo in subjects with irritable... [read full story]