A Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide in Children With Functional Constipation (Allergan)
Principal Investigator: Prof. Ilse Hoffman
Functional constipation (FC) is a common disorder in children with complaints of hard stool and painful excretion which can lead to abdominal pain and fecal inconsistency. As a consequence, quality of life could be reduced with increased absences from school and increased health care costs. The first-line treatment consists of non-pharmacological interventions such as education, behavioral changes, and keeping a diary. However, pharmacological treatment is often required. Multiple pharmacological products are available for FC treatment, but no well-controlled clinical trials are performed with pharmacological treatment in children.
In de LIN-MD-64 studie worden kinderen (6-18 jaar) gerandomiseerd in de behandelingsgroep met linaclotide of in de placebogroep voor een periode van 12 weken om de veiligheid en doeltreffendheid van linaclotide te evalueren in kinderen met functionele constipatie.