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

Gastroesophageal Reflux Disease research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastroesophageal Reflux Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Nexium®

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Esomeprazole (40mg) + Sodium Bicarbonate (721mg)

Nexium®

Study Status

Withdrawn

Start Date:

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Efficacy

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Eurofarma Laboratorios S.A.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01471925

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