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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Rifamycin (Primary)
  • Indications Traveller's diarrhoea
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies; Cosmo Pharmaceuticals; Salix Pharmaceuticals; Santarus

    • Most Recent Events

    • 31 Oct 2023 Results assessing to improve the prediction of prognosis and to optimize treatments, a simple risk-based clinical severity classification has been developed from Pooled data from NCT01142089 and NCT01208922, published in the Journal of Travel Medicine.
    • 05 Dec 2022 According to RedHill Biopharma media release, company announced that the U.S. Food and Drug Administration's (FDA) Exclusivity Board has granted Aemcolo five years exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years' data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.
    • 23 May 2021 Results of a pooled analysis of data from two phase III studies (NCT01142089 and NCT01208922) reassessing the efficacy of Rifamycin SV presented at the Digestive Disease Week 2021

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