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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Nexium®
* Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole (40mg) + Sodium Bicarbonate (721mg)<br> | Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)<br> <br> |
| Active Comparator: Nexium®<br> | Drug: Nexium®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Primary efficacy analysis the value for intragastric pH 10 centimeters distant from the lower esophageal sphincter and the pH value 1 hour after using study medication during randomization visit will be considered for primary study assessment. | 1 month |