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

Inclusion Criteria:

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

Exclusion Criteria:

• Intake of PPI or Marial® during the last 28 days before the start of the study.
• Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs)including COX-2-inhibitors (≥ 3 consecutive days per week) during the last 28 daysbefore the start of the study; except regular intake of enteric coated aspirin dosagesup to 150 mg/d.
• Previously underwent acid-lowering surgery or other surgery of the oesophagus and/orupper gastrointestinal tract (excluding appendectomy, cholecystectomy andpolypectomy).
• History of co-existing disease that affects the esophagus (e.g. Barrett's esophagus,Zollinger-Ellison syndrome, esophageal stricture).
• History of active gastric or duodenal ulcers within 3 months of the first dose of thestudy drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
• Documented presence of severe renal or hepatic insufficiency (i.e. GOT, GPT elevatedover double the normal range).
• Known hypersensitivity to omeprazole, and/or Marial® and/or Gaviscon®.
• Concurrent (or within 30 days of study entry) participation in a clinical trial.
• Females who are pregnant, or planning a pregnancy, or lactating. Females of childbearing potential not using reliable methods of birth control.
• Clinically significant laboratory abnormality or disease which, in the opinion of theInvestigator, will create a risk for the patient, or interfere with study results (i.e. GOT, GPT elevated over double the normal range).
• Receiving any of the following drugs within 2 weeks before the baseline: theophylline,bismuth salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram,barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate,clopidogrel or protease inhibitors. Benzodiazepines could be allowed only inconcomitance with the endoscopy.
• Taking concomitant medications that rely on the presence of gastric acid for optimalbioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
• Drug or alcohol abuse within 12 months of Day 0
• Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except fortreated basal cell/squamous cell carcinoma of the skin).
• Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt orsuicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
• Presence of any clinically significant medical condition judged by the investigator topreclude the patient's inclusion in the study for its safety