ARTICLE | Clinical News

Linaclotide: Completed Phase III enrollment

August 30, 2010 7:00 AM UTC

Ironwood completed enrollment of about 800 patients in each of two double-blind, placebo-controlled North American Phase III trials of linaclotide. One study is evaluating 266 µg oral linaclotide given once daily for 26 weeks, while the other study is evaluating similar dosing of linaclotide for 12 weeks, followed by a 4-week randomized withdrawal period. Ironwood and U.S. partner Forest also amended the protocol to add an endpoint measuring abdominal pain and CSBM responsiveness for 6 out of the 12 weeks, in addition to 9 out of the 12 weeks as originally designed. The companies said the change was made to be consistent with FDA draft guidance that was issued this year on IBS-C studies. ...