A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

About the trial

Sponsor

AbbVie (with Ironwood Pharmaceuticals, Inc.)

Tested

Linaclotide (drug), Placebo (drug)

Dates

Started 2023-04-27; completion 2025-06-09

Results posted

Yes

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 who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, …

From ClinicalTrials.gov, last updated 2026-01-06. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $257,222 in research payments for this study in 2025 (72 payments).

Products named: Linzess

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.