NCT04130659

Study to Evaluate the Performance and Safety of the MARIAL® in Association With PPI Versus PPI Alone

Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device Marial® In Association With Proton-Pump Inhibitors Versus PPI Alone In Patients Affected By Gastroesophageal Reflux Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nekkar Lab Srl · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Many patients with acid reflux disease do not improve with regular doses of proton pump inhibitors (e.g., omeprazole). The goals of this clinical trial is the to see if taking MARIAL®, in combination with omeprazole, for one month improves symptoms of acid reflux disease compared to taking omeprazole alone. Furthermore, this study will verify the effectiveness of MARIAL® as a maintenance treatment for the next five months. This trial is called by the registered name GENYAL®.

Detailed description

This is an open-label, comparative, multicenter study with two parallel groups of patients. The clinical trial has the registered name GENYAL® and will be conducted at five clinical sites. The study population will include patients affected by gastroesophageal reflux disease (GERD) with a diagnosis of Los Angeles Classification System Grade A reflux esophagitis confirmed by gastroscopy (performed within 1 month prior to baseline) and clinical symptoms in the past 2 weeks. Patients will be randomized to receive MARIAL® (E-Gastryal®+Magnesium Alginate) plus omeprazole versus omeprazole alone (1 month) followed by Marial® alone for an additional 5 months. The products will be administered following the respective Summary of Product Characteristics. The Investigators chosen the number of rescue medicine used (tablets of Gaviscon®) as a primary efficacy outcome to measure the performance between the two groups. The study will enroll 110 patients. MARIAL® is a class IIa medical device that is already marketed in several EU countries. It is a combination of E-Gastryal® (hyaluronic acid, hydrolyzed keratin, tara gum, xantan gum, purified water) and magnesium alginate (MgAlg). It has been proven to actively regenerate damaged tissues through its repair and regenerative properties on the mucous membranes and its mucoadhesive and film-forming properties, which prolong the contact time with the mucous membranes and consequently improve their effectiveness.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MARIAL® + PPI (generic Omeprazole)	MARIAL® administration: 1 stick twice daily after meals from day 1 to 28. Omeprazole administration: 20 mg cps once daily from day 1 to day 28
DRUG	PPI alone (generic omeprazole)	Omeprazole administration: 20 mg cps once daily from day 1 to day 28
DEVICE	MARIAL® alone	MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.

Timeline

• Start date: 2019-08-08
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2019-10-17
• Last updated: 2023-12-15

Locations

5 sites across 2 countries: Italy, Romania