Gastroesophageal Reflux Disease
Conditions
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).
Interventions
DRUGNexium®
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.
DRUGEsomeprazol (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.
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 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. |
Countries
Brazil
Outcome results
None listed