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A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438, 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis

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A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438, 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2024

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At a glance

  • Drugs Vonoprazan (Primary) ; Lansoprazole
  • Indications Erosive oesophagitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 20 Apr 2024 Results evaluating the noninferiority of vonoprazan vs. lansoprazole as maintenance therapy in patients with healed Erosive esophagitis (EE) published in the Chinese Medical Journal.
    • 13 Oct 2020 Results of sub group analysis evaluating the non-inferiority of vonoprazan compared to lansoprazole in the maintenance phase of healed EE in Chinese patients presented at the 28th United European Gastroenterology Week
    • 19 May 2020 Primary endpoint has been met. (Percentage of Participants with Recurrence of Erosive Esophagitis as Confirmed on Endoscopy after the 24-week Maintenance Phase)

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