A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period 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-1
- 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.
- 07 Nov 2017 According to an Ardelyx media release, results from the trial were presented at the American College of Gastroenterology (ACG) Annual Meeting 2017.
- 16 Oct 2017 According to an Ardelyx media release, results from this trial will be presented at the American College of Gastroenterology (ACG) World Congress 2017. Bill Chey is the principal investigator of the T3MPO clinical program.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History