CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,743 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/NCT00730171
NCT00730171Phase 3Completed
CompareCT.gov

An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Ironwood Pharmaceuticals, Inc.·interventional·Posted Aug 8, 2008·Updated Feb 19, 2018

In Brief

A Phase 3 clinical trial evaluating Linaclotide for Irritable Bowel Syndrome With Constipation and Chronic Constipation. Completed, enrolled 1,743 participants across 116 sites.

Detailed Summary

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Constipation, Chronic Constipation
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartSep 1, 2008
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.9 years ago

Interventions

Linaclotidedrug

Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.