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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation.

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 May 2023

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At a glance

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

Most Recent Events

  • 01 May 2023 Results (n=2350) of post hoc analysis pooled from studies (NCT02559206, NCT03573908, NCT00948818, and NCT00938717) published in the American Journal of Gastroenterology
  • 26 Oct 2022 Results(n=2073) of post hoc analysis pooled from studies(NCT02559206,NCT00948818, NCT00938717 and NCT03573908) assessing the Safety and Efficacy of Linaclotide in Patients With Irritable Bowel Syndrome and Constipation presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022
  • 27 Oct 2021 Results pooled analysis (of data pooled from NCT00460811, NCT00948818, NCT00938717, and NCT03573908 studies assessing symptoms of Irritable Bowel Syndrome With constipation presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021

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