drugset / Trial / NCT01471925
Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
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
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Esomeprazole | Small molecule | 40 mg | Oral |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 721 mg | Oral |