Symptomatic response to GERDOFF® in patients with gastro-esophageal reflux disease and poor response to alginates: An exploratory, post-market, open-label study

Abstract

Background/Aims: A novel medical device based on hyaluronic acid, chondroitin sulfate plus aluminum hydroxide [GERDOFF® (SOFAR S.p.A., Trezzano Rosa, Italy), melt-in-mouth tablets] showed efficacy in reducing gastroesophageal reflux (GER)-related symptoms. This exploratory, open-label study aimed to evaluate symptomatic effects of a 14-day treatment with GERDOFF® in gastroesophageal reflux disease (GERD) patients. Materials and Methods: GERD Impact Scale (GIS) questionnaire was filled at baseline visit and after 7 and 14 days of treatment; patients' global satisfaction was evaluated at the final visit. Primary endpoint was the reduction of heartburn episodes per week; secondary endpoints were GERD-related symptoms, patients' satisfaction, and safety. Results: A total of 40 patients were included, of which, 22 were on stable therapy with proton pump inhibitor (PPI). Compared with baseline, the days with heartburn episodes and the GIS score progressively decreased during the first (p<0.0001) and the second weeks of treatment (p<0.0001). Heartburn episodes per week (p<0.0001) and the GIS score (p<0.0001) decreased in the first and the last 7 days of the 14-day treatment and did not differ between patients on and off PPI. The treatment was safe and well-tolerated, and it was rated as very good (46.2%) or good (43.6%) on the satisfaction questionnaire. Conclusion: GERDOFF® could effectively treat GER symptoms in patients not responding to PPI or alginate-based formulation. ISRCTN 15143752.