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A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the Primary Eradication of H.Pylori.

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Trial Profile

A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the Primary Eradication of H.Pylori.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2016

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At a glance

  • Drugs Vonoprazan (Primary) ; Amoxicillin; Clarithromycin; Lansoprazole
  • Indications Helicobacter pylori infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 02 Mar 2016 Results published in the Gut
    • 26 Mar 2015 According to a Takeda and Otsuka media release, Takeda submitted a NDA to the Ministry of Health, Labour and Welfare, Japan for a single pack containing drugs for the eradication of Helicobacter Pylori. One pack contains three drugs, vonoprazan fumarate, amoxicillin and clarithromycin for the first eradication, and other pack contains drugs, vonoprazan fumarate, amoxicillin and metronidazole for the second eradication of Helicobacter pylori.
    • 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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