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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 770 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 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 6 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, Taiwan and Philippines. 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.


Sponsor: Takeda

Current Primary Outcome: Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer(s) [ Time Frame: Week 4 or Week 6 ]

Rate of endoscopic healing is defined as the percentage of participants in whom the disappearance of all white coats associated with duodenal ulcers has been endoscopically confirmed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment [ Time Frame: After 4 or 6 weeks of treatment (up to 10 weeks) ]
    HP infection status will be determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
  • Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 [ Time Frame: Week 4 ]
    Rate of endoscopic healing is defined percentage of participants in whom the disappearance of all white coats associated with duodenal ulcers has been endoscopically confirmed.
  • Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 [ Time Frame: Week 2 up to Week 6 ]
    Gastrointestinal symptoms are defined as: epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: February 8, 2017
Date Started: April 2017
Date Completion: October 2018
Last Updated: February 8, 2017
Last Verified: February 2017