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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
Instituto Goiano de Gastroenterologia
Goiânia, Goiás, Brazil
Centro de pesquisa Clínica do Serviço de gastroenterologia
Rio de Janeiro, Rio de Janeiro, Brazil
Mãe de Deus Center
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica de Campinas
Canpinas, São Paulo, Brazil
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.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil