Gastroesophageal Reflux DiseasePhase 3NCT01471925
Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
A Phase 3 study testing Nexium® and Esomeprazol (40mg) + Sodium Bicarbonate (721mg) in people with Gastroesophageal Reflux Disease, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Nexium® and Esomeprazol (40mg) + Sodium Bicarbonate (721mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesBrazil
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Centro de Pesquisa Clínica de Campinas
Canpinas, São Paulo
Instituto Goiano de Gastroenterologia
Goiânia, Goiás
Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo
Mãe de Deus Center
Porto Alegre, Rio Grande do Sul
Centro de pesquisa Clínica do Serviço de gastroenterologia
Rio de Janeiro, Rio de Janeiro
Hospital Israelita Albert Einstein
São Paulo, São Paulo
About this study
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
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).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Nexium®, Esomeprazol (40mg) + Sodium Bicarbonate (721mg)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexium®Drug
The medication, esomeprazole magnesium trihydrate (40 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml.
The study treatment will last a total of 28 days.
Esomeprazol (40mg) + Sodium Bicarbonate (721mg)Drug
The medication, Esomeprazol (40 mg) + Sdium Bicarbonate (721 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml.
The study treatment will last a total of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole (40mg) + Sodium Bicarbonate (721mg) | Experimental | Not described Receives: Drug: Esomeprazol (40mg) + Sodium Bicarbonate (721mg) |
| Nexium® | Active comparator | Not described Receives: Drug: Nexium® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
Why it stopped: Change company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471925
- Sponsor's protocol ID
- EF 095
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2011
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01471925
- Acronym / sponsor ID
- EF 095
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole (40mg) + Sodium Bicarbonate (721mg) | Experimental | Drug: Esomeprazol (40mg) + Sodium Bicarbonate (721mg) |
| Nexium® | Active comparator | Drug: Nexium® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexium®The medication, esomeprazole magnesium trihydrate (40 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml. The study treatment will last a total of 28 days. | Drug | Nexium® |
| Esomeprazol (40mg) + Sodium Bicarbonate (721mg)The medication, Esomeprazol (40 mg) + Sdium Bicarbonate (721 mg), should be administered once a day (before breakfast) and the capsules should be taken on an empty stomach (orally) with liquid (water at room temperature - 200 to 250 ml. The study treatment will last a total of 28 days. | Drug | Esomeprazole (40mg) + Sodium Bicarbonate (721mg) |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nexium® and Esomeprazol (40mg) + Sodium Bicarbonate (721mg) in people with Gastroesophageal Reflux Disease, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.