drugset / Trial / NCT01471925

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

NCT01471925

Phase 3 Withdrawn Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg Oral
Subject sodium bicarbonate Diagnostic / imaging agent 721 mg Oral