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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Vonoprazan (Primary) ; Amoxicillin; Clarithromycin; Lansoprazole; Tripotassium dicitratobismuthate
  • Indications Duodenal ulcer
  • Focus Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 27 Mar 2022 Results published in the Journal of Gastroenterology and Hepatology
    • 13 Oct 2020 Results assessing efficacy and safety of vonoprazan versus lansoprazole in the treatment of duodenal ulcer in Asian patients presented at the 28th United European Gastroenterology Week.
    • 19 May 2020 Primary endpoint has been met. (Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers)

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