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

Eurofarma

Status and phase

Withdrawn

Phase 3

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Nexium®

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01471925

EF 095

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.