Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double‐blind, placebo‐controlled study

Background Clinical testing to determine a suitable dose of linaclotide for Japanese patients with irritable bowel syndrome with constipation ( IBS ‐C) was needed. Methods This was a randomized, double‐blind, placebo‐controlled, dose‐finding trial. Japanese patients with IBS ‐C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the...