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).

Trial Profile

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
  • Most Recent Events

    • 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.
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