CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 805 enrolled
Drug / intervention
Linaclotide or Matching Placebodrug
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/NCT00938717
NCT00938717Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation

Ironwood Pharmaceuticals, Inc.·interventional·Posted Jul 14, 2009·Updated Nov 5, 2013

In Brief

A Phase 3 clinical trial evaluating Linaclotide or Matching Placebo for Irritable Bowel Syndrome With Constipation. Completed, enrolled 805 participants across 107 sites.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.0 years ago

Interventions

Linaclotide or Matching Placebodrug

Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial