A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 07 Nov 2017
At a glance
- Drugs Tenapanor (Primary)
- Indications Irritable bowel syndrome
- Focus Registrational; Therapeutic Use
- Acronyms T3MPO-2
- Sponsors Ardelyx
- 07 Nov 2017 According to an Ardelyx media release, the company expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of 2018 seeking marketing authorization for tenapanor in IBS-C.
- 11 Oct 2017 Results presented in an Ardelyx media release.
- 11 Oct 2017 Primary endpoint (Percentage of Subjects with Overall Response for 6 out of 12 Weeks) has been met according to an Ardelyx media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History