drugset / Trial / NCT04110145

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

NCT04110145

Phase 2 Completed 35 enrolled Allergan Ironwood Pharmaceuticals, Inc. · collab
RandomizedSequentialTriple-blindTreatment

Summary

The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.

Timeline

Start
2019-10-14
Primary completion
2021-04-20
Completion
2021-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Linaclotide Peptide 18 ug Oral
Subject Linaclotide Peptide 36 ug Oral
Subject Linaclotide Peptide 72 ug Oral

Indications