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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm (total of 188 patients).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

ICF signing;

• Age ≥ 18 years;

• Gastroesophageal reflux disease diagnosis;

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

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

• Washout period of 1 week without using PPI, H2 antagonists and prokinetic agents and of 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 creatinine concentrations;

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

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

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

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

• 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 or sucrose-isomaltase insufficiency;

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