Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04130659
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2019-10-14
Brief Title:
Study to Evaluate the Performance and Safety of the MARIAL in Association With PPI Versus PPI Alone
Sponsor:
Nekkar Lab Srl
Organization:
Nekkar Lab Srl
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENYAL
Brief Summary:
Many patients with acid reflux disease do not improve with regular doses of proton pump inhibitors eg 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
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-GastryalMagnesium 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
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-GastryalMagnesium 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004062-17 | EUDRACT_NUMBER | None | None |