The USA's Lexicon Pharmaceuticals has initiated a Phase II trial of LX1031, its oral drug candidate for the treatment of irritable bowel syndrome.
The trial, which began at the end of last year, is a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. The study will include 150 patients with either diarrhea-predominant IBS or mixed IBS. Two dose levels will be evaluated: 250mg and 1,000mg, each administered four times daily. The endpoints will include assessments of the effects of LX1031 on specific symptoms associated with IBS, as well as a global assessment of adequate relief.
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