Sucampo Pharmaceuticals Inc. (SCMP) announced that it has closed enrollment and initial dosing of patients in two pivotal phase 3 trials of lubiprostone for the treatment of Opioid-Induced Bowel Dysfunction or OBD.
The OBD Pivotal Assessment of Lubiprostone program is designed to evaluate the effect of lubiprostone as a treatment for chronic pain patients suffering from constipation and associated symptoms as a result of chronic opioid therapy. Constipation and associated symptoms are a common side effect of the use of narcotic medications, such as morphine, codeine and hydrocodone, which are prescribed for chronic pain management. A total of 875 patients diagnosed with OBD were enrolled at 187 sites in the US and Canada. Patients will receive one 24-mcg gel capsule of lubiprostone twice a day or placebo for 12 weeks. The primary endpoint of the trial is the change from baseline in the frequency of spontaneous bowel movements at week 8.
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