M21-572

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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) with a 24-week Open-label Treatment Extension

Sex at Birth: Any
Age: Child (Birth - 17)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase III
Conditions Being Studied: Functional Constipation

Study Purpose

The purpose of this study is to learn about the long-term safety and efficacy (how well a drug works) of a study drug called Linaclotide for the treatment of functional constipation (FC) in pediatric subjects aged 2 to 5 years.

Principal Investigator
Thomas Sferra MD

Department/Division
Gastroenterology (Pediatrics)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

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UH IRB: SITE00001988
StudyID: 2023-01193
ClinicalTrials.gov: NCT05652205

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