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A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) With a 24-week Open-label Treatment Extension

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) With a 24-week Open-label Treatment Extension

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Linaclotide (Primary)
  • Indications Constipation
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AbbVie

Most Recent Events

  • 07 May 2025 Protocol amended to change the trial focus from TU to TU and AR.
  • 07 May 2025 Planned primary completion date changed from 1 Aug 2025 to 1 Sep 2025.
  • 18 Mar 2025 Status changed from recruiting to active, no longer recruiting.

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