At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 481 enrolled
Drug / intervention
Vonoprazan +3 moredrug
Likely dose
Not stated in 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 Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis
In Brief
A Phase 3 clinical trial evaluating Vonoprazan, Lansoprazole, and 2 other interventions for Erosive Esophagitis. Completed, enrolled 481 participants across 64 sites in 4 countries.
Detailed Summary
The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Esophagitis
CountriesChina, Malaysia, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMar 2015
Primary CompletionJul 2017
TodayJul 2026
First PostedMar 17, 2015
Enrollment StartMar 24, 2015
Primary CompletionJul 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago
Interventions
Vonoprazandrug
Vonoprazan tablets
Lansoprazoledrug
Lansoprazole capsules
Vonoprazan Placebodrug
Vonoprazan placebo-matching tablets
Lansoprazole Placebodrug
Lansoprazole placebo-matching capsules