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
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®.
• Male or non-pregnant female, both aged ≥ 18 to ≤ 65 years.
• Diagnosis of GERD Grade A esophagitis on Los Angeles Classification System grades reflux esophagitis by:
‣ gastroscopy (done within 1-month prior baseline).
⁃ episodic heartburn and/or acid regurgitation (at least 3 times per week in the last 2 weeks);
• Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
• Capable of and freely willing to provide written informed consent prior to participating in the study.