At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,027 enrolled
Drug / intervention
Vonoprazan +1 moredrug
Likely dose
Vonoprazan 240 mLfrom 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.
A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis
In Brief
A Phase 3 clinical trial evaluating Vonoprazan and Lansoprazole for Erosive Esophagitis. Completed, enrolled 1,027 participants across 157 sites in 6 countries.
Detailed Summary
To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Esophagitis
CountriesBulgaria, Czechia, Hungary, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionJul 2021
Study CompletionAug 2021
TodayJul 2026
First PostedOct 14, 2019
Enrollment StartOct 28, 2019
Primary CompletionJul 29, 2021
Study CompletionAug 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.7 years ago
Interventions
Vonoprazandrug
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Lansoprazoledrug
Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.