Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
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ClinicalTrials.gov Identifier: NCT01471925
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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).
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
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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);
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.