A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)
Abstract
The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.
Conditions: Erosive Esophagitis.
Primary outcome: Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment.
Enrollment: 607 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 607 participants or records.
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