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A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

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Trial Profile

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2019

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At a glance

  • Drugs Linaclotide (Primary)
  • Indications Irritable bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors AstraZeneca

    • Most Recent Events

    • 18 Jan 2019 According to an AstraZeneca media release, based on the data of this phase III trial, the companys partner Ironwood Pharmaceuticals, Inc. has received marketing authorisation from the National Medical Products Administration (NMPA) for Linzess (linaclotide) in China for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).
    • 10 Jan 2018 Results (n=839) assessing the efficacy and tolerability of linaclotide in patients with irritable bowel syndrome with constipation, published in the Journal of Gastroenterology and Hepatology.
    • 19 Oct 2016 Results (n=839) presented at the 24th United European Gastroenterology Week

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