Last updated on December 2018

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis


Brief description of study

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

Detailed Study Description

The drug being tested in this study is called vonoprazan. Vonoprazan is being tested as a maintenance treatment for people with healed erosive esophagitis (EE). This study will look at participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to Lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

The study will enroll approximately 693 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groupswhich will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • TAK-438 10 mg
  • TAK-438 20 mg
  • Lansoprazole 15 mg

Participants with ongoing erosive esophagitis (EE) will receive lansoprazole 30 mg once daily for 4 or 8 weeks (the Healing phase) until healing of EE is confirmed by endoscopy performed at either Week -4 and/or Day 1 before eligible for randomization to maintenance phase. In Maintenance phase, participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast 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-centre trial will be conducted worldwide. The overall time to participate in this study is 8 months. 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.

Clinical Study Identifier: NCT02388737

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Takeda Study Registration Call Center

Peking Union Medical College Hospital
Beijing, China
0.49miles
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Peking University First Hospital
Beijing, China
0.97miles
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PLA.The Military General Hospital of Beijing
Beijing, China
2.27miles
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Beijing Friendship Hospital, Capital Medical University
Beijing, China
2.75miles
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Takeda Study Registration Call Center

Beijing Chao Yang Hospital
Beijing, China
4.62miles
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The General Hospital of Peoples Armed Police Forces China
Beijing, China
5.2miles
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Beijing Tongren Hospital, Capital Medical Univeristy
Beijing, China
5.57miles
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Recruitment Status: Open


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