NCT02388724

Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan tablets
DRUG	Lansoprazole	Lansoprazole capsules
DRUG	Vonoprazan Placebo	Vonoprazan placebo-matching tablets
DRUG	Lansoprazole Placebo	Lansoprazole placebo-matching capsules

Timeline

• Start date: 2015-03-24
• Primary completion: 2017-07-27
• Completion: 2017-07-27
• First posted: 2015-03-17
• Last updated: 2019-06-03
• Results posted: 2019-06-03

Locations

64 sites across 4 countries: China, Malaysia, South Korea, Taiwan