Clinical Trial: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Functional Constipation (FC)
Study Type: INTERVENTIONAL
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) Wi
Brief Summary:
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.Currently, there are no pharmacological therapies approved for the treatment of FC.This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV…
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