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Recruitment Status : Withdrawn (Change company strategy)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.

October 31, 2011
November 16, 2011
July 27, 2015
Not Provided
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01471925 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
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
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).
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: Nexium®
  • Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
  • Experimental: Esomeprazole (40mg) + Sodium Bicarbonate (721mg)
    Intervention: Drug: Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
  • Active Comparator: Nexium®
    Intervention: Drug: Nexium®
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EF 095
Not Provided
Not Provided
Eurofarma Laboratorios S.A.
Eurofarma Laboratorios S.A.
Not Provided
Not Provided
Eurofarma Laboratorios S.A.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP