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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation.

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 May 2017

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At a glance

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

Most Recent Events

  • 09 May 2017 Results (n=3536) assessing placebo relative effect of Linaclotide and Plecanatide on efficacy and safety using patient data pooled from 4 phase 3 trials (NCT00730015, NCT00765882, NCT01982240, NCT02122471), presented at the Digestive Disease Week 2017
  • 11 Aug 2011 Results published in the New England Journal of Medicine.
  • 10 May 2011 Results of two identical phase III trials [clinical trial profile 700037954 and 700038135] presented at the Digestive Disease Week 2011.

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