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A Randomized Placebo-Controlled Phase 3 Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection in Non-investigated Dyspepsia Patients

Trial Profile

A Randomized Placebo-Controlled Phase 3 Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection in Non-investigated Dyspepsia Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Amoxicillin/omeprazole/rifabutin (Primary)
  • Indications Helicobacter pylori infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ERADICATE-Hp
  • Sponsors RedHill Biopharma
  • Most Recent Events

    • 04 Nov 2019 According to an RedHill Biopharma media release, the company will host an Investor and Analyst day on November 22, 2019 in New York to review launch plans for Talicia and provide an overview of the Company's commercial operations.
    • 04 Nov 2019 According to an RedHill Biopharma media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved Talicia(omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults.
    • 21 Aug 2019 According to a RedHill Biopharma media release, the company will present data from the positive Phase 3 clinical studies of RHB-105 (Talicia) for H. pylori infection at the upcoming American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting (October 25-30, 2019).
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