Cobiprostone for Prevention of Severe Oral Mucositis in Head and Neck Cancer

Phase 2, randomised, double-blind trial in oral mucositis (OM) comparing Cobiprostone with Placebo (2 arms). Primary endpoints: Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy up to 12 weeks and Overall mean Area Under the Curve (AUC) of oral mucositis severity over time up to 12 weeks. Started Jun 2015; status: terminated.