Phase 3 study of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD)
Sucampo and Takeda Pharmaceuticals announced the dosing of the first patient in the third Phase 3 trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone.
Sucampo plans to enroll a total of 420 patients at up to 140 sites in the U.S. and Europe. Patients will be randomized to receive either placebo or lubiprostone 24 mcg gel capsule twice daily throughout the 12-week treatment period. Patients must have been treated for chronic, non-cancer related pain with any opioid other than methadone for at least 30 days prior to screening, and will continue opioid therapy throughout the study. Patients must have OBD, which is defined as having an average of fewer than 3 spontaneous bowel movements (SBMs) per week during the 3-week screening period with hard or very hard stools, sensation of incomplete evacuation, or moderate to very severe straining with at least 25% of their SBMs while on opioid-based therapy. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of SBMs.
Lubiprostone (marketed as Amitiza by Sucampo and Takeda), is a chloride channel activator currently indicated for the treatment chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation (IBS-C) in women ≥18 years of age.