Last updated on March 2019

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection


Brief description of study

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with gastric ulcer.

Detailed Study Description

The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have stomach ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at stomach ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole.

The study will enroll approximately 830 patients.

Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groupswhich will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):

  • TAK-438 20 mg
  • Lansoprazole 30 mg

Study treatment will depend upon the Helicobacter pylori infection status of the participant, and include bismuth-containing quadruple therapy for the first 2 weeks in H pylori infected (HP+) participants. HP+ participants will be asked to take a TAK- 438 tablet or a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet or a lansoprazole capsule once daily for up to 6 weeks. HP- participants will be asked to take a TAK-438 tablet or a lansoprazole capsule once daily for up to 8 weeks.

This multi-center trial will be conducted in China, Korea, Taiwan and Philippines. The overall time to participate in this study is up to 16 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT03050307

Find a site near you

Start Over

Korea University Ansan Hospital

Ansan-si, Korea, Republic of
  Connect »

Wonkwang University Hospital

Iksan-si, Korea, Republic of
  Connect »

Dong-A University Hospital

Busan, Korea, Republic of
  Connect »

Kangbuk Samsung Hospital

Seoul, Korea, Republic of
  Connect »

De La Salle University Medical Center

Dasmarinas City, Cavite, Philippines
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.