Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety: A Study to Evaluate the Safety of Long-term Administration of Vonoprazan in Maintenance Treatment in Patients With Erosive Esophagitis (EE)
Abstract
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.
Conditions: Erosive Esophagitis.
Primary outcome: Number of Participants With Malignant Alteration of Epithelial Cells; Number of Participants With Parietal Cell Protrusion/Hyperplasia; Number of Participants With Foveolar Hyperplasia; Number of Participants With Enterochromaffin-like-cell Hyperplasia; Number of Participants With G-cell Hyperplasia.
Enrollment: 208 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 208 participants or records.
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