Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

Summary

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.

Timeline

Start

2019-10-01

Primary completion

2024-05-20

Completion

2024-05-29

Outcome

Met primary endpoint

registry analysis (superiority test); FC Participants: Placebo vs FC Participants: Linaclotide 72 μg; p < 0.0001; Difference 1.170 (95% CI 0.651 to 1.689); ANCOVA NCT04026113 ↗

Publications

• Person H, Hyams JS, Sanghavi RM, Shakhnovich V, Kosch K, Li M, D'Achino D, Khlevner J, Chumpitazi BP, Saps M. A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders. J Pediatr Gastroenterol Nutr. 2026 Mar 30. doi: 10.1002/jpn3.70424. Online ahead of print.
• Di Lorenzo C, Khlevner J, Rodriguez-Araujo G, Xie W, Huh SY, Ando M, Hyams JS, Nurko S, Benninga MA, Simon M, Hewson ME, Saps M. Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):238-250. doi: 10.1016/S2468-1253(23)00398-9. Epub 2024 Jan 8.

Drugs

Indications