Date: 2015-05-07
Type of information: Clinical trial autorization
phase: 2
Announcement: clinical trial authorisation
Company: Sucampo Pharmaceuticals (USA - MD)
Product: Amitiza® (lubiprostone)
Action
mechanism: prostaglandin. Amitiza® (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated in the United States (U.S.) for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. Amitiza® is also indicated in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan , Amitiza® (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the U.K. , Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In Switzerland, Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of Amitiza® for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.
Disease: prevention of oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy
Therapeutic area: Cancer - Oncology - Inflammatory diseases
Country: USA
Trial details:
Latest
news: * On May 7, 2015, Sucampo Pharmaceutical announced that the FDA has accepted the company\'s Investigational New Drug (IND) application to initiate a phase 2 clinical trial of cobiprostone for the prevention of oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy. The company plans to initiate this proof-of-concept, Phase 2 study for cobiprostone in oral mucositis by the end of the quarter.
