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: 09 Aug 2017
At a glance
- Drugs Tenapanor (Primary)
- Indications Irritable bowel syndrome
- Focus Registrational; Therapeutic Use
- Acronyms T3MPO-1
- Sponsors Ardelyx
- 09 Aug 2017 According to a company media release, based on the results of the T3MPO-1 trial and pending T3MPO-2 results, Ardelyx is preparing for its first New Drug Application (NDA) for tenapanor for the treatment of IBS-C, which the company currently expects to submit in 2018.
- 12 May 2017 Top-line results published in an Ardelyx media release.
- 12 May 2017 Primary endpoint (6 of 12 Week Overall Responder Rate) 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