Sucampo, Takeda Begin Constipation Trials

Sucampo Pharmaceuticals and development and commercialization partner Takeda Pharmaceuticals have begun global pivotal Phase III program to study lubiprostone in pediatric functional constipation. Functional constipation is a very common gastrointestinal complaint in children and is on the rise. An analysis of longitudinal data in the U.S. showed a nearly fourfold increase in rates of constipation over the last decade.

Lubiprostone is the world’s first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. This Phase III program was preceded by an open-label trial in 124 patients aged three to 17 years, which suggested that lubiprostone warrants further investigation as a potential treatment for children and adolescents with functional constipation.

The first Phase III trial in the program, which has just been initiated, is a randomized, placebo-controlled, double-blind study of the efficacy, safety and pharmacokinetics of lubiprostone in pediatric subjects between the ages of 6 to 17. The trial is expected to enroll more than 500 patients with pediatric functional constipation at up to 100 sites across the U.S., Canada, and Europe. Subjects will be treated for 12 weeks with weight-based dosages of 12 mcg or 24 mcg twice daily (BID). The primary endpoint for this trial is overall spontaneous bowel movement (SBM) response. An SBM is a bowel movement that occurs without the use of another constipation treatment such as a laxative, enema, or suppository, during the 24 hours prior to occurrence.

This clinical program consists of two well-controlled pivotal studies with similar design,  the one mentioned above and another testing lubiprostone liquid formulation in patients aged 6 months to under 6 years. Sucampo also plans to evaluate the long-term safety of lubiprostone in these populations through two open-label extension studies. Sucampo plans to file an sNDA with the FDA following program completion, which is anticipated by early 2016.