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)

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 04 May 2017

At a glance

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

    • 19 Oct 2016 Results (n=839) presented at the 24th United European Gastroenterology Week
    • 19 May 2016 According to an Ironwood Pharmaceuticals media release, the company will present clinical data from this study at the Digestive Disease Week (DDW) 2016.
    • 08 Jul 2015 According to AstraZeneca media release, the company intends to file in early 2016 for China Food and Drug Administration (CFDA) approval to market linaclotide.
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