CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 420 enrolled
Drug / intervention
Linaclotide Acetate +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.

Search/NCT00460811
NCT00460811Phase 2Completed
CompareCT.gov

A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation

Ironwood Pharmaceuticals, Inc.·interventional·Posted Apr 16, 2007·Updated Feb 4, 2013

In Brief

A Phase 2 clinical trial evaluating Linaclotide Acetate and Matching placebo for Irritable Bowel Syndrome With Constipation. Completed, enrolled 420 participants across 85 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Constipation
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 16, 2007
Enrollment StartApr 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.2 years ago

Interventions

Linaclotide Acetatedrug

Oral, once daily

Matching placebodrug

Oral, once daily