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

This study is not yet open for participant recruitment.
Verified November 2011 by Eurofarma Laboratorios S.A.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01471925
First received: October 31, 2011
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: Nexium®
Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 188
Arms Assigned Interventions
Experimental: Esomeprazole (40mg) + Sodium Bicarbonate (721mg) Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
Active Comparator: Nexium® Drug: Nexium®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471925

Contacts
Contact: Carine Sanches +551141449682 carine.martins@eurofarma.com.br

Locations
Brazil
Instituto Goiano de Gastroenterologia Not yet recruiting
Goiania, GO, Brazil
Principal Investigator: Mauro Bafutto, MD            
Mãe de Deus Center Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Carlos Fernando Francesconi, MD            
Principal Investigator: Carlos Fernando Francesconi, MD            
Centro de pesquisa Clínica do Serviço de gastroenterologia Not yet recruiting
Rio de janeiro, RJ, Brazil
Principal Investigator: Cyrla Zaltman, MD            
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, SP, Brazil
Principal Investigator: Flavio Steinwurz, MD            
Centro de Pesquisa Clínica de Campinas Not yet recruiting
Canpinas, São Paulo, Brazil
Principal Investigator: Flavio Quilici, MD            
Centro de Estudos Clínicos do Interior Paulista Not yet recruiting
Jaú, São Paulo, Brazil
Principal Investigator: Rodrigo José Polonio, MD            
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01471925     History of Changes
Other Study ID Numbers: EF 095
Study First Received: October 31, 2011
Last Updated: November 10, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013