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)

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2018

At a glance

  • Drugs Plecanatide (Primary)
  • Indications Constipation; Irritable bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Synergy Pharmaceuticals Inc
  • Most Recent Events

    • 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
    • 25 Jan 2018 According to a Synergy Pharmaceuticals Inc. media release, the US FDA has approved TRULANCE (plecanatide 3mg tablet) for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C). The regulatory application was based on data from this and second phase III trial (SP304203-04).
    • 07 Jun 2017 According to a Synergy Pharmaceuticals media release, the US FDA has accepted for filing the company's sNDA for TRULANCE (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) based on data from this and second phase III trial (SP304203-04). The Prescription Drug User Fee Act (PDUFA) date is January 24, 2018.
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