drugset / Trial / NCT01132638

Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease

NCT01132638

Phase 3 Completed 713 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.

Timeline

Start
2011-08
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg Oral
Comparator Pantoprazole Other / unclassified 40 mg Oral