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Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Trial Profile

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2019

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At a glance

  • Drugs Plecanatide (Primary)
  • Indications Irritable bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 17 Jul 2018 Results from two phase 3 randomized trials (NCT02387359 and NCT02493452; n=2189) assessing safety and efficacy of plecanatidepublished in the Annals of Internal Medicine.
    • 15 Mar 2018 Results of two phase 3 randomized trials (NCT02387359 and NCT02493452; n=2189) assessing safety and efficacy of plecanatide, published in the American Journal of Gastroenterology
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