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

Status:

WITHDRAWN

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

Lead Sponsor:

Eurofarma Laboratorios S.A.

Conditions:

Gastroesophageal Reflux Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 gastroesophag...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01471925

Last Update

April 1 2025

Active Locations (6)

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Page 1 of 2 (6 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