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

NCT ID: NCT01471925

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

Brief 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).

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esomeprazole (40mg) + Sodium Bicarbonate (721mg)

Group Type: EXPERIMENTAL

Esomeprazol (40mg) + Sodium Bicarbonate (721mg)

Intervention Type: DRUG

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.

Nexium®

Group Type: ACTIVE_COMPARATOR

Nexium®

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Goiano de Gastroenterologia

Goiânia, Goiás, Brazil

Centro de pesquisa Clínica do Serviço de gastroenterologia

Rio de Janeiro, Rio de Janeiro, Brazil

Mãe de Deus Center

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisa Clínica de Campinas

Canpinas, São Paulo, Brazil

Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF 095

Identifier Type: -

Identifier Source: org_study_id