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: 07 Jun 2017

At a glance

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

    • 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.
    • 10 May 2017 According to a Synergy Pharmaceuticals media release, pooled analysis from this and another study (CTP700247364) presented at Digestive Disease Week (DDW) 2017.
    • 09 May 2017 Results of two identical trials (NCT02493452 and NCT02387359) assessing the efficacy and safety of once-daily plecanatide in IBS-C patients, presented at the Digestive Disease Week 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top