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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01471925
• Other study ID #: EF 095
• Status: Withdrawn
• Phase: Phase 3
• First received: October 31, 2011
• Last updated: July 24, 2015

Study information

• Verified date: November 2011
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Nexium®

• Esomeprazol (40mg) + Sdium Bicarbonate (721mg)

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica de Campinas	Canpinas	São Paulo
Brazil	Instituto Goiano de Gastroenterologia	Goiania	GO
Brazil	Centro de Estudos Clínicos do Interior Paulista	Jaú	São Paulo
Brazil	Mãe de Deus Center	Porto Alegre	Rio Grande do Sul
Brazil	Centro de pesquisa Clínica do Serviço de gastroenterologia	Rio de janeiro	RJ
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	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.	1 month	Yes