Efficacy and Safety of Esolgafate, A Pre-Polymerized Cross-Linked Sucralfate Medical Device for NERD. A Randomized Double-Blind Placebo-Controlled Trial

Background: Unlike those with erosive reflux disease, patients with non-erosive reflux disease fail to adequately respond to proton pump inhibitors (PPI’s). Pre-polymerized sucralfate barrier therapy (PPSBT) recognized by US FDA as a medical device has significantly enhanced mucosal bioadherence compared to standard sucralfate drug. Aim: To evaluate whether enhanced mucosal protection by PPSBT can provide relevant symptom relief for NERD compared to placebo, even in undifferentiated population of NERD patients. Methods: In a multi-center randomized double-blind placebo controlled trial 42 patient with NERD were randomized to receive Esolgafate, a pre-polymerized cross-linked sucralfate barrier therapy or placebo. No pH monitoring was conducted to determine representative proportion of the 3 sub-types of NERD. Antacids were available to each group as rescue medication. Symptoms of heartburn, reflux sensation, retrosternal discomfort were evaluated before and after treatment. Adverse events were assessed. Results: At the end of the trial, for patients taking PPSBT primary endpoints were met in 90% for heartburn, 83.3% for reflux sensation and 88.2 % for retrosternal discomfort compared to 11.1%, 25% and 20% for those using placebo (p <0.01). Conclusion: The barrier effect of Esolgafate suggests that enhanced mucosal protection by PPSBT alone could improve symptom control in NERD patients undifferentiated by sub-type of non-erosive heartburn.