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
Latest Information Update: 14 May 2025
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.