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

NCT01471925 | Withdrawn Phase 3

• 1 other identifier: EF 095
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Nexium®

ACTIVE COMPARATOR

Drug: Nexium®

Interventions

Nexium® 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.

Nexium®

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (6)

Instituto Goiano de Gastroenterologia

Goiânia, Goiás, Brazil

Location

Centro de pesquisa Clínica do Serviço de gastroenterologia

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Mãe de Deus Center

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Pesquisa Clínica de Campinas

Canpinas, São Paulo, Brazil

Location

Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole; Omeprazole; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 16, 2011
• Last Updated: April 1, 2025

Record last verified: 2011-11

Locations

BR (6)