The study will compare the dose response of oral Amitiza (lubiprostone) with that of placebo in patients with chronic idiopathic constipation. Approximately 160 patients are expected to be enrolled at 13 sites. Patients will be randomized to one of three twice-daily doses of lubiprostone (8mcg, 16mcg or 24mcg capsule) or placebo. Patients will be dosed for 14 days. The primary endpoint of the study will be the number of spontaneous bowel movements after one week on treatment.
Ryuji Ueno, founder, chairman and CEO of Sucampo Pharmaceuticals, said: “Initiation of this study is a key step in our Amitiza commercialization strategy, which includes actively pursuing geographical expansion in addition to the expansion of indications and dosage formulations.”
Kunihiko Soneoka, president and CEO of Sucampo Pharma, said: “It is a great step forward for the company to have an opportunity to study the safety and efficacy of lubiprostone in Japanese patients, who may be unsatisfied with traditional treatment options for this condition, including lifestyle and dietary changes, laxatives and stool softeners.”