CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 828 enrolled
Drug / intervention
Linaclotidedrug
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.

Search/NCT02590432
NCT02590432Phase 4Completed
CompareCT.gov

An Open-label, Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation.

Forest Laboratories·interventional·Posted Oct 29, 2015·Updated Aug 22, 2019

In Brief

A Phase 4 clinical trial evaluating Linaclotide for Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation. Completed, enrolled 828 participants across 79 sites.

Detailed Summary

The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Constipation, Chronic Idiopathic Constipation
CountriesUnited States
CollaboratorsIronwood Pharmaceuticals, Inc.

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2015
Enrollment StartNov 1, 2015
Primary CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.7 years ago

Interventions

Linaclotidedrug

Linaclotide capsules, orally, once daily.