Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC

Inclusion Criteria:

ICF signing;

• Age ≥ 18 years;

• Gastroesophageal reflux disease diagnosis;

• Grade 0 to grade III reflux esophagitis, assessed by means of upper gastrointestinalendoscopy;

• Ability to have the endoscopy, pH-metry and esophageal manometry examinationsperformed;

• Washout period of 1 week without using PPI, H2 antagonists and prokinetic agents andof at least 1 day without using antacids.

Exclusion Criteria:

• Presence of esophagitis requiring intervention (grade IV), esophageal varices,Barrett's esophagus, systemic sclerosis or ulcers (gastric or duodenal ulcers);

• Previous gastric or esophageal surgery;

• Dietary sodium restriction, metabolic alkalosis, hypokalemia, Barter syndrome;Pregnancy or breastfeeding;

• Concomitant diseases, such as kidney, liver and heart failure;

• Suspected or confirmed cancer of any type;

• Abusive drug or alcohol use;

• Abnormal values for white blood cells, platelets or hemoglobin;

• Significant changes in serum sodium, potassium, calcium or creatinineconcentrations;

• Treatment with PPI, H2 antagonists or prokinetic agents that may not be withheldduring the washout period of 1 week or during the study;

• Intolerance or allergy to any of the components in the drug products assessed in thestudy;

• Use of nonsteroidal anti-inflammatory drugs (NSAIDs), antiemetic agents, macrolideantibiotics and systemic corticoids for a period equal to or greater than 2 weeksbefore the study or that is expected to require prolonged use during studytreatment;

• Concomitant use or requirement of a gastric pH-dependent medication for optimalabsorption;

• Scheduled use of other medications metabolized by cytochrome CYP during the study;

• History of active peptic ulcer;

• Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption orsucrose-isomaltase insufficiency;

• Recent participation (within the last 12 months) in another clinical study.