Research Article
Efficacy and Safety of Esolgafate, A Pre-Polymerized Cross-Linked Sucralfate Medical Device for NERD. A Randomized Double-Blind Placebo-Controlled Trial
Ricky Wayne McCullough1,2*
1Translational Medicine Clinic and Research Center, USA
2Department of Internal Medicine and Emergency Medicine, Warren Alpert Brown University School of Medicine, USA
Ricky Wayne McCullough, Translational Medicine Clinic and Research Center, Storrs Connecticut, USA.
Received Date: April 13, 2020; Published Date: April 22, 2020
Abstract
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.
Keywords: Polymerized sucralfate; NERD; Barrier therapy; Sucralfate suspension
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Ricky Wayne McCullough. Efficacy and Safety of Esolgafate, A Pre-Polymerized Cross-Linked Sucralfate Medical Device for NERD. A Randomized Double-Blind Placebo-Controlled Trial. Acad J Gastroenterol & Hepatol. 2(2): 2020. AJGH.MS.ID.000532.