Study Shows Linaclotide Beneficial for Pediatric Functional Constipation

The phase 3 trial included patients 6 to 17 years of age who fulfilled modified Rome III Criteria for child/adolescent functional constipation.

Treatment with linaclotide improved the frequency of spontaneous bowel movements (SBM) and stool consistency in pediatric patients with functional constipation, according to positive topline data from a phase 3 trial.

The multicenter, randomized, double-blind, parallel-group trial ( Identifier: NCT04026113) evaluated the efficacy and safety of linaclotide, a guanylate cyclase-C agonist, in 330 patients 6 to 17 years of age who fulfilled modified Rome III Criteria for child/adolescent functional constipation. Patients were randomly assigned 1:1 to receive either linaclotide 72mcg orally once daily or placebo. 

Findings showed that treatment with linaclotide met the primary endpoint demonstrating a statistically significant and clinically meaningful improvement in the 12-week SBM frequency rate (SBMs/week) compared with placebo. The least squares mean change from baseline in SBMs/week was greater than 2-fold (2.22) in the linaclotide treatment arm compared with the placebo arm (1.05) (P <.0001).

Moreover, treatment with linaclotide resulted in an improvement in stool consistency vs placebo, as assessed by Bristol Stool Form Scale scores (least squares mean change from baseline at week 12: 1.108 points vs 0.685 points, respectively; P =.0001). The most frequently reported treatment-emergent adverse event was diarrhea, which occurred in 4.3% of linaclotide-treated patients vs 1.8% of placebo-treated patients.

“We are excited by the results of this phase 3 trial and are focused on identifying an expeditious regulatory path forward, with our partner AbbVie, to support delivering this potential first functional constipation therapeutic to pediatric patients ages 6 to 17 in need,” said Mike Shetzline, MD, PhD, chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals.

Linaclotide is currently marketed under the brand name Linzess® for the treatment of adults 18 years of age and older with irritable bowel syndrome with constipation or chronic idiopathic constipation.


Ironwood Pharmaceuticals reports positive topline data from phase III trial of Linzess® (linaclotide) in pediatric patients aged 6-17 with functional constipation. News release. Ironwood Pharmaceuticals, Inc. Accessed September 6, 2022.