Erosive Esophagitis Clinical Trial
Official title:
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
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.
The drug being tested in this study is called vonoprazan. Vonoprazan is being tested to treat
people who have erosive esophagitis. This study will look at mucosal healing of people who
take vonoprazan versus lansoprazole.
This study will enroll approximately 480 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the two treatment groups—which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- Vonoprazan 20 mg
- Lansoprazole 30 mg
All participants will be asked to take one tablet and one capsule at the same time each day
throughout the study. All participants will be asked to record daytime and nighttime (during
sleep) subjective symptoms in a diary on a daily basis.
This multi-center trial will be conducted worldwide. The overall time to participate in this
study is up to 11 weeks. Participants will make multiple visits to the clinic, and will be
contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment.
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