Duodenal Ulcer Clinical Trial
Official title:
A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helicobacter Pylori Infection
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat
people who have duodenal ulcers and also may or may not have Helicobacter pylori (HP)
infection. This study will look at duodenal ulcer healing and also the elimination of HP in
people who take TAK-438 versus lansoprazole. The study will enroll approximately 530
patients.
Participants were randomly assigned (by chance, like flipping a coin) to one of the two
treatment groups—which remained undisclosed to the participant and study doctor during the
study (unless there is an urgent medical need):
- TAK-438 20 mg
- Lansoprazole 30 mg
HP+ participants will be asked to take a TAK- 438 tablet and a lansoprazole capsule twice
daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a
TAK-438 tablet and a lansoprazole capsule once daily for up to 4 weeks. HP negative (HP-)
participants will be asked to take a TAK-438 tablet and a lansoprazole capsule once daily for
up to 6 weeks.
This multi-center trial will be conducted China, Korea and Taiwan. The overall time to
participate in this study is up to 10 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.
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