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A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers during Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers during Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2018

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At a glance

  • Drugs Vonoprazan (Primary) ; Lansoprazole
  • Indications NSAID-induced ulcer
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 07 Oct 2017 Primary endpoint (Recurrence rate of gastric or duodenal ulcer within 24 weeks) has been met as per the results published in the Gut
    • 07 Oct 2017 Results published in the Gut
    • 07 May 2014 According to a Takeda media release, the results of this trial will be presented at the Digestive Disease Week 2014.

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