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A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

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Trial Profile

A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Rabeprazole (Primary)
  • Indications Gastro-oesophageal reflux
  • Focus Registrational; Therapeutic Use
  • Acronyms the Japan-based EXTEND study
  • Sponsors Eisai Co Ltd

    • Most Recent Events

    • 22 Sep 2017 Results published in an an Eisai Co Ltd media release.
    • 22 Sep 2017 Primary endpoint has been met (Rate of non-recurrence) according to an Eisai Co Ltd media release.
    • 22 Sep 2017 According to an Eisai Co Ltd media release, based on the results from this study the company has received the approval of additional dosage and administration in Japan of the proton pump inhibitor Pariet 5 mg Tablets and 10 mg Tablets to administer 10 mg of rabeprazole sodium per dose twice-daily for the maintenance therapy of proton pump inhibitor-resistant reflux esophagitis.
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