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news.Sucampo Pharmaceuticals and Abbott have reported positive results from a 48-week Phase III long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC).
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The study results showed that lubiprostone was safe and well-tolerated.
The long-term Phase III safety trial was an open-label, multi-centre study which enrolled 209 Japanese patients with a history of fewer than three SBMs per week for at least six months.
During the study, the patients received one 24mcg lubiprostone capsule twice a day for a period of 48 weeks.
The safety results of the study showed that the most common adverse drug reactions were diarrhea (37.3%), chest discomfort (7.2%), nausea (27.3%) and abdominal pain (5.3%) which were transient in duration.
In February 2009, Sucampo entered into a drug development partnership with Abbott Japan under which Abbott will have exclusive rights to commercialise lubiprostone in Japan for CTC treatment.