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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471925
Recruitment Status : Withdrawn (Change company strategy)
First Posted : November 16, 2011
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Brief 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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Esomeprazole (40mg) + Sodium Bicarbonate (721mg) Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
Active Comparator: Nexium® Drug: Nexium®

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 1 month ]
    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:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471925

Instituto Goiano de Gastroenterologia
Goiania, GO, 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, Brazil
Centro de Pesquisa Clínica de Campinas
Canpinas, São Paulo, Brazil
Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.

Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01471925     History of Changes
Other Study ID Numbers: EF 095
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: November 2011

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action