At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 208 enrolled
Drug / intervention
Vonoprazan +1 moredrug
Likely dose
Vonoprazan 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Vonoprazan and Lansoprazole for Erosive Esophagitis. Completed, enrolled 208 participants across 36 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Esophagitis
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionMar 2022
TodayJul 2026
First PostedFeb 10, 2016
Enrollment StartMar 20, 2016
Primary CompletionMar 5, 2022
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 10.4 years ago
Interventions
Vonoprazandrug
Vonoprazan fumarate 10 mg or 20 mg capsules
Lansoprazoledrug
Lansoprazole 15 mg or 30 mg capsules