drugset / Trial / NCT02679508

Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

NCT02679508

Phase 4 Completed 208 enrolled Takeda
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.

Timeline

Start
2016-03-20
Primary completion
2022-03-05
Completion
2022-03-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lansoprazole Other / unclassified 15 mg Oral
Comparator Lansoprazole Other / unclassified 30 mg Oral
Subject Vonoprazan Other / unclassified 10 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral

Indications