Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Drug: Esomeprazol (40mg) + Sodium Bicarbonate (721mg)
- Registration Number
- NCT01471925
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esomeprazole (40mg) + Sodium Bicarbonate (721mg) Esomeprazol (40mg) + Sodium Bicarbonate (721mg) - Nexium® Nexium® -
- Primary Outcome Measures
Name Time Method Efficacy 1 month 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Hospital Israelita Albert Einstein
🇧🇷São Paulo, SP, Brazil
Instituto Goiano de Gastroenterologia
🇧🇷Goiania, GO, Brazil
Centro de Pesquisa Clínica de Campinas
🇧🇷Canpinas, São Paulo, Brazil
Centro de Estudos Clínicos do Interior Paulista
🇧🇷Jaú, São Paulo, Brazil
Centro de pesquisa Clínica do Serviço de gastroenterologia
🇧🇷Rio de janeiro, RJ, Brazil
Mãe de Deus Center
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil