drugset / Trial / NCT02388737

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

NCT02388737

Phase 3 Completed 703 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

Timeline

Start
2015-04-01
Primary completion
2018-12-24
Completion
2018-12-31

Drugs

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

Indications