Randomized clinical trial: Randomized, controlled, single-blind, three-way crossover study to evaluate the efficacy and safety of a new preparation for post-prandial heartburn

Abstract

Heartburn is a prevalent symptom related to gastro-oesophageal reflux. Its treatment includes, amongst others, the use of alginates, which combine a rapid onset of action with a longer duration of symptom relief than antacids. The aim of this study was to investigate the time to onset of action of two alginate preparations, Reduflux® liquid sachets (RL) and Reduflux® chewable tablets (RT). This was a randomized, placebo-controlled, single-blind, three-way crossover clinical investigation with subjects prone to suffer from post-prandial heartburn. Heartburn was triggered by a refluxogenic meal and subjects were randomized to receive RL, RT or placebo. Subjects identified the onset of perception of soothing and cooling effects in the throat and oesophagus, by using a previously described dual-stopwatch method. 48 subjects were screened, 42 were randomized and 41 completed the study. Mean time to onset of soothing was 1.71, 1.92, and 29.43 min, for RL, RT and placebo, respectively (p < 0.001). Mean time to onset of cooling was 0.76, 0.78, and 28.83 min, for RL, RT and placebo, respectively (p < 0.001). Only 1 out of 41 subjects experienced reappearance of heartburn in the 4 h after symptoms relief in each of the RL and RT groups. RL and RT were considered highly efficacious and safe by both the investigator and subjects. In conclusion, Reduflux® chewable tablet and liquid sachet were efficacious in the treatment of post-prandial heartburn, providing a quick onset and a long duration of action, with sustained symptoms relief in 97% of the subjects.

Keywords: Gastro-oesophageal reflux, heartburn treatment, alginates, Reduflux®.