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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Nexium®
Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Goiano de Gastroenterologia
  • Mãe de Deus Center
  • Centro de pesquisa Clínica do Serviço de gastroenterologia
  • Hospital Israelita Albert Einstein
  • Centro de Pesquisa Clínica de Campinas
  • Centro de Estudos Clínicos do Interior Paulista

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Nexium®

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2011
Last Updated
July 24, 2015
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01471925
Brief Title
Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Change company strategy
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole (40mg) + Sodium Bicarbonate (721mg)
Arm Type
Experimental
Arm Title
Nexium®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nexium®
Intervention Type
Drug
Intervention Name(s)
Esomeprazol (40mg) + Sdium Bicarbonate (721mg)
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Instituto Goiano de Gastroenterologia
City
Goiania
State/Province
GO
Country
Brazil
Facility Name
Mãe de Deus Center
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
Centro de pesquisa Clínica do Serviço de gastroenterologia
City
Rio de janeiro
State/Province
RJ
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Centro de Pesquisa Clínica de Campinas
City
Canpinas
State/Province
São Paulo
Country
Brazil
Facility Name
Centro de Estudos Clínicos do Interior Paulista
City
Jaú
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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