Klinische studies kindergastro-enterologie

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.

Samenvatting

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.

Laatste aanpassing: 6 oktober 2020