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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Esomeprazol (40mg) + Sodium Bicarbonate (721mg); Drug: Nexium®

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Goiania, GO, Brazil
      • Instituto Goiano de Gastroenterologia
  • RJ
    • Rio de janeiro, RJ, Brazil
      • Centro de pesquisa Clínica do Serviço de gastroenterologia
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Mãe de Deus Center
  • SP
    • São Paulo, SP, Brazil
      • Hospital Israelita Albert Einstein
  • São Paulo
    • Canpinas, São Paulo, Brazil
      • Centro de Pesquisa Clínica de Campinas
    • Jaú, São Paulo, Brazil
      • Centro de Estudos Clinicos do Interior Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esomeprazole (40mg) + Sodium Bicarbonate (721mg)	Drug: Esomeprazol (40mg) + Sodium Bicarbonate (721mg); The medication, Esomeprazol (40 mg) + Sdium Bicarbonate (721 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml. The study treatment will last a total of 28 days.
Active Comparator: Nexium®	Drug: Nexium®; The medication, esomeprazole magnesium trihydrate (40 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml. The study treatment will last a total of 28 days.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimated): November 16, 2011

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Gastroenteritis; Duodenal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophagitis; Peptic Ulcer; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: EF 095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No