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news.Sucampo Pharmaceuticals has completed Phase 3 double blind trial of Lubiprostone (marketed as Amitiza in the US) for chronic idiopathic constipation (CIC) in Japanese patients.
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Sucampo claimed that the trial met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.
The primary endpoint of the trial was a change in the number of spontaneous bowel movements (SBMs) at the end of the first week of treatment. The pivotal, double-blinded, placebo-controlled trial evaluated 124 Japanese CIC patients each of whom received one Lubiprostone 24-mcg, or placebo, capsule twice daily for 28 days.
Sucampo said that it would continue to conduct a long-term, open-label, multi-center, confirmatory, safety trial in 209 Japanese CIC patients. Top-line results from the safety trial are expected during the fourth quarter of 2010.
R-Tech Ueno has an agreement with Sucampo Pharma (SPL), a wholly owned subsidiary of Sucampo, under which it has the exclusive right to manufacture and supply Lubiprostone (marketed as Amitiza in the US) in Japan, Asia, Oceania and other regions.