NCT03883074

Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: SOFAR S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DEVICE	hyaluronic acid with chondroitin + sulphate + magnesium trisilicate	Melt in mouth tablets (1100 mg)
DEVICE	Placebo	tablets with the same aspect of the active device

Timeline

• Start date: 2018-12-20
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2019-03-20
• Last updated: 2022-05-06

Locations

1 site across 1 country: Belgium