Sucampo Pharma Begins Lubiprostone Study
Sucampo Pharma Ltd. has started a Phase IIb dose-ranging study in Japan to evaluate the safety and efficacy of lubiprostone for adult chronic idiopathic constipation.
The multicenter, randomized, parallel-group, double-blind, placebo-controlled study will compare the dose response of oral lubiprostone with placebo. Approximately 160 patients will be enrolled at 13 sites.
Patients will receive one of three twice-daily doses of lubiprostone or placebo for 14 days. The primary endpoint of the study will be the number of spontaneous bowel movements after one week on treatment, Sucampo said.
The company co-markets lubiprostone in the U.S. as Amitiza, which was launched in April 2006.