At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
In Brief
A Phase 3 clinical trial evaluating Vonoprazan, Lansoprazole, and 2 other interventions for Erosive Esophagitis. Completed, enrolled 703 participants across 72 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Vonoprazan tablets
Lansoprazole capsules or tablets
Vonoprazan placebo-matching tablets
Lansoprazole placebo-matching capsules