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Phase 3 Withdrawn Eurofarma Laboratorios S.A.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
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Primary completion
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Completion
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Outcome

Outcome not reported

Stopped (Business): “Change company strategy”

Drugs

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