Carlo Di Lorenzo, Julie Khlevner, Gerardo Rodriguez-Araujo, Wangang Xie, Susanna Y Huh, Masakazu Ando, Jeffrey S Hyams, Samuel Nurko, Marc A Benninga, Michael Simon, Marcella E Hewson, Miguel Saps
BACKGROUND: Linaclotide, a guanylate cyclase C agonist, has been approved in the USA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with predominant constipation in adults. We aimed to assess the efficacy and safety of linaclotide in paediatric patients aged 6-17 years with functional constipation. METHODS: This randomised, double-blind, placebo-controlled, multicentre, phase 3 study was done at 64 clinic or hospital sites in seven countries (USA, Canada, Israel, Italy, the Netherlands, Ukraine, and Estonia)...
March 2024: Lancet. Gastroenterology & Hepatology