NCT03050307

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

A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20mg Compared to Lansoprazole 30mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Gastric Ulcer Subjects With or Without Helicobacter Pylori Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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 groups-which 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 12 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.

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	TAK-438	TAK-438 tablets
DRUG	Lansoprazole	Lansoprazole capsules
DRUG	TAK-438 Placebo	TAK-438 placebo-matching tablets
DRUG	Lansoprazole Placebo	Lansoprazole placebo-matching capsules
DRUG	Bismuth-Containing Quadruple Therapy	1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).

Timeline

• Start date: 2017-04-17
• Primary completion: 2020-02-19
• Completion: 2020-05-26
• First posted: 2017-02-10
• Last updated: 2021-06-18
• Results posted: 2021-06-18

Locations

81 sites across 4 countries: China, Philippines, South Korea, Taiwan