A randomized, double-blind, placebo-controlled pilot study to evaluate the efficacy and tolerability of a novel oral bioadhesive formulation for the treatment of nonerosive reflux disease-related symptoms

Objective The use of antisecretory drugs can provide symptomatic relief in 70–80% of patients suffering from gastro-oesophageal reflux disease (GORD), although this benefit is reduced by 20–30% in the case of nonerosive reflux disease (NERD). The current study evaluates the efficacy and safety of a patented oral formulation (liquid sachets containing hyaluronic acid, a mixture of amino acids including proline, hydroxyl-proline and glutamine, and rice extract dispersed in a bioadhesive polymer matrix) for relieving the symptoms of NERD. Methods A single-centre, randomized, double-blind, parallel group, placebo-controlled clinical study was performed. Patients who experienced at least three episodes of moderate-severity heartburn during the 7-day run-in period were included and treated with three liquid sachets per day for 14 days. The primary objective was to evaluate the proportion of patients with at least a three-point reduction in the total symptom score (TSS). Results Overall, 20 patients were randomized to receive the investigational product and 20 to receive the placebo. At the end of treatment, a three-point reduction in the TSS was achieved by 95% of patients treated with the investigational product and by 20% of patients treated with placebo (P
Source: European Journal of Gastroenterology and Hepatology - Category: Gastroenterology Tags: Original Articles: Gastroenterology Source Type: research