NCT04202692

Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

Evaluation of the Performance and Safety of an Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and Magnesium Trisilicate (GERDOff® Plus) in Patients With Gastro-Esophageal Reflux Disease: A Double-blind, Placebo-controlled, Randomized, Cross-over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: SOFAR S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs. Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet	1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
DEVICE	Placebo 1100 mg, identically-looking melt in mouth tablet	1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks

Timeline

• Start date: 2019-11-05
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2019-12-17
• Last updated: 2023-04-12

Locations

2 sites across 1 country: Germany