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

NCT04110145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-04-26

Study results available
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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.

Conditions

  • Functional Constipation

Interventions

DRUG

Linaclotide

Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state.

DRUG

Placebo

Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Anna Muslin · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2021-04-20
Completion
2021-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110145 on ClinicalTrials.gov