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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

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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 Aug 2023

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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

    • 01 Aug 2023 According to a RedHill Biopharma media release, Gaelan Medical received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin).
    • 04 Nov 2022 Results of post hoc analysis of pooled, modified intention-to-treat data from 293 subjects in the Phase 3 trials (NCT01980095/ NCT03198507) presented at The Obesity Society: ObesityWeek 2022.
    • 12 Jul 2022 According to a RedHill Biopharma media release, publication of a study entitled Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia) is Unaffected by High Body Mass Index in the journal GastroHep has been selected by reviewers for oral presentation at the World Gastro 2022 congress.
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