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WITHDRAWN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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1
Instituto Goiano de Gastroenterologia
Goiânia, Goiás, Brazil
2
Centro de pesquisa Clínica do Serviço de gastroenterologia
Rio de Janeiro, Rio de Janeiro, Brazil
3
Mãe de Deus Center
Porto Alegre, Rio Grande do Sul, Brazil
4
Centro de Pesquisa Clínica de Campinas
Canpinas, São Paulo, Brazil