July 1, 2008
Salix Initiates Phase III Irritable Bowel Syndrome Trial
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 bowel syndrome (IBS) who are not currently experiencing symptoms of constipation, referred to as non-constipation IBS.
The primary efficacy endpoint of Target 1 and Target 2 is the proportion of subjects who achieve adequate relief of IBS symptoms for at least two weeks during the first four weeks of the 10-week follow-up phase.
Bill Forbes, vice president of R&D at Salix, said: "We are very pleased to now initiate these two multicenter trials - Target 1 and Target 2 - to further evaluate the efficacy of rifaximin as a treatment option in this disease which is associated with widespread prevalence, incapacitating symptoms and substantial medical costs."