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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 mcg or 145 mcg) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 mcg or 145 mcg) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

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

    • Most Recent Events

    • 26 Jan 2017 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) has approved a 72 mcg dose of LINZESS (linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.
    • 09 Jun 2016 According to an Ironwood Pharmaceuticals and Allergan media release, based on the results of this trial, the US FDA accepted to review the sNDA for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation. The PDUFA target action date is expected in early 2017.
    • 11 Feb 2016 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
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