At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Linaclotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) With Functional Constipation
In Brief
A Phase 2 clinical trial evaluating Linaclotide and Placebo for Functional Constipation. Completed, enrolled 35 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Constipation
CountriesUnited States
CollaboratorsIronwood Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionApr 2021
TodayJul 2026
First PostedOct 1, 2019
Enrollment StartOct 14, 2019
Primary CompletionApr 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.8 years ago
Interventions
Linaclotidedrug
Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state.
Placebodrug
Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state