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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)

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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: 13 Nov 2023

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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

  • 09 May 2023 Results of post hoc pooled analysis (n=2176) assessing plecanatide for simultaneously improving these patient-reported outcomes, using composite endpoints, as healthcare providers must rely upon symptom improvement to measure IBS treatment success from NCT02387359 and NCT02493452 studies, presented at the Digestive Disease Week 2023.
  • 26 Oct 2022 Results of a pooled post-hoc analysis from two clinical studies (NCT02387359 and NCT02493452) assessing change from baseline at week 12 in abdominal pain and bloating symptoms in overall population and those with severe baseline abdominal pain and bloating presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022
  • 26 Oct 2022 Results of post hoc pooled analysis from NCT01982240; NCT02122471, NCT02387359, NCT02493452; evaluating the potential impact of age on plecanatide efficacy in Chronic Idiopathic Constipation and IBS-C, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022

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