NCT05652205

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

• Functional Constipation (FC)
• Chronic Idiopathic Constipation (CIC)

Interventions

Type	Name	Description
DRUG	Linaclotide	Capsule; oral
DRUG	Placebo for Linaclotide	Capsule; oral

Timeline

• Start date: 2022-12-29
• Primary completion: 2025-09-02
• Completion: 2025-09-02
• First posted: 2022-12-15
• Last updated: 2025-09-16

Locations

48 sites across 4 countries: United States, Bulgaria, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study