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First received: December 02, 2022

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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