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®.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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
Omeprazole administration: 20 mg cps once daily from day 1 to day 28
MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.
UOC Endoscopia Digestiva Chirurgica Policlinico Gemelli - Universita Cattolica
Roma, Italy
RECRUITINGCabinet Particular Policlinic Algomed
Timișoara, Timiș County, Romania
COMPLETEDSocietatea Civilă Medicală Gados
Timișoara, Romania
COMPLETEDTotal Gaviscon® tablets consumption by patients using alginate as rescue medication
The 28-day visit will assess the outcome by reviewing the patients' diary card. This diary card records their usage of Gaviscon® tablets and calculates the number of unused Gaviscon® tablets they received during baseline. The consumption of Gaviscon® tablets from baseline to the final visit in the Marial® + PPI group will be compared to that of the PPI-only group.
Time frame: 28 days
Reflux Symptoms Index (RSI)
RSI is a nine-item self-administered outcome instrument with a maximum total score of 45. The total score can range from zero to 45, with each item being measured using a 6-point rating scale from no problem (0) to severe problem (5). If the score is greater than 13, the RSI will be clinically significant and indicative of reflux disease.
Time frame: 180 days
GERD Impact Scale (GIS)
The GERD Impact Scale (GIS) consists of nine questions that cover acid-related symptoms, chest pain, extra-esophageal symptoms, and how the symptoms affect a patient's daily life, including sleep, work, meals, social occasions, and use of over-the-counter medications. The patient will provide their responses using the following four-point Likert scale; 1=none of the time, 2=a little of the time, 3=some of the time, and 4=all of the time for the seven days leading up to the study visit.
Time frame: 180 days
GERD Health-Related Quality of Life (GERD-HRQL)
This study employs the 10-item version of the GERD-HRQL questionnaire (Velanovich, V. Diseases of the Esophagus, 2007), which measures intensity and frequency of heartburn, difficulty in swallowing, bloating, and burden of GERD medications. . Responses are rated on a scale of 1 to 5. 0 = No symptoms, 1 = Noticeable but not bothersome, 2 = Noticeable and bothersome but not occurring every day, 3 = Bothersome on a daily basis, 4 = Bothersome and affecting daily activities, 5 = Incapacitating in terms of daily activities. An additional patient-reported global satisfaction score is not added to the total GERD-HRQL score. Hence, the maximum score for this test is 50 and higher scores indicate more severe symptoms and a reduced health-related quality of life.
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Medlife SA
Timișoara, Romania
COMPLETEDCentrul Medical Salvosan Ciobanca
Zalău, Romania
COMPLETEDTime frame: 180 days
Investigator Global Assessment of the Performance (IGAP)
Investigator Global Assessment of the Performance (IGAP) will be scored by Investigator as: 1= very good performance, 2 = good performance, 3 = moderate performance and 4 = poor performance. IGAP will be evaluated at day 28 and day 180, only.
Time frame: 180 days
Investigator Global Assessment of Safety (IGAS)
Investigator Global Assessment of Safety (IGAS) will be measured using the following 4-point verbal rating scale:1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAP will be evaluated at day 28 and day 180, only.
Time frame: 180 days
Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE), and Device Deficiency (DD)
Serious Adverse Device Effects (SADE), Serious Adverse Events (SAE), Adverse Device Effects (ADE), Adverse Events (AE), and Device Deficiency (DD) will be collected and reported by the investigators during the study period. Their incidence will be assessed based on the change from the baseline.
Time frame: 180 days
Esophagogastroduodenoscopy (EGD)
Esophagogastroduodenoscopy (EGD) will be evaluated as exploratory outcome. It is a minimally invasive diagnostic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Prior to the procedure, benzodiazepine will be administered for sedation. EGD will be performed at baseline and on day 28 for the 16 patients included in the Italian site only.
Time frame: 28 days
GERD recurrence rate
GERD recurrence rate will be evaluated as an exploratory outcome. The rate of GERD recurrence will be assessed by comparing the change from day 28 to day 180.
Time frame: 150 days