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)
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
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History