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Completed Phase 2 Interventional Results available

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

ClinicalTrials.gov ID: NCT02559206

Public ClinicalTrials.gov record NCT02559206. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).

Study identification

NCT ID
NCT02559206
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Enrollment
759 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 22, 2015 (Actual)
Primary completion
Sep 30, 2016 (Actual)
Completion
Sep 30, 2016 (Actual)
Last update posted
Apr 24, 2020

2015 – 2016

United States locations

U.S. sites
71
U.S. states
27
U.S. cities
64
Facility City State ZIP Site status
Ironwood Investigational Site Huntsville Alabama 35801 —
Ironwood Investigational Site Phoenix Arizona 85018 —
Ironwood Investigational Site Tucson Arizona 85712 —
Ironwood Investigational Site North Little Rock Arkansas 72117 —
Ironwood Investigational Site Anaheim California 92801 —
Ironwood Investigational Site Chula Vista California 91910 —
Ironwood Investigational Site Garden Grove California 92843 —
Ironwood Investigational Site La Mesa California 91942 —
Ironwood Investigational Site Newport Beach California 92660 —
Ironwood Investigational Site Orange California 92868 —
Ironwood Investigational Site San Diego California 92108 —
Ironwood Investigational Site Thousand Oaks California 91360 —
Ironwood Investigational Site Colorado Springs Colorado 80904 —
Ironwood Investigational Site Bristol Connecticut 06010 —
Ironwood Investigational Site Waterbury Connecticut 06708 —
Ironwood Investigational Site Hialeah Florida 33016 —
Ironwood Investigational Site Kissimmee Florida 34744 —
Ironwood Investigational Site Miami Florida 33015 —
Ironwood Investigational Site Miami Florida 33135 —
Ironwood Investigational Site Miami Florida 33165 —
Ironwood Investigational Site Miami Florida 33175 —
Ironwood Investigational Site Orlando Florida 32806 —
Ironwood Investigational Site South Miami Florida 33143 —
Ironwood Investigational Site Tampa Florida 33634 —
Ironwood Investigational Site West Palm Beach Florida 33409 —
Ironwood Investigational Site Atlanta Georgia 30328 —
Ironwood Investigational Site Oakwood Georgia 30566 —
Ironwood Investigational Site Sandy Springs Georgia 30328 —
Ironwood Investigational Site Evansville Indiana 47714 —
Ironwood Investigational Site Bastrop Louisiana 71220 —
Ironwood Investigational Site Metairie Louisiana 70006 —
Ironwood Investigational Site Shreveport Louisiana 71105 —
Ironwood Investigational Site Baltimore Maryland 21215 —
Ironwood Investigational Site Chevy Chase Maryland 20815 —
Ironwood Investigational Site Boston Massachusetts 02131 —
Ironwood Investigational Site Watertown Massachusetts 02472 —
Ironwood Investigational Site Chesterfield Michigan 48047 —
Ironwood Investigational Site Wyoming Michigan 49519 —
Ironwood Investigational Site Jackson Mississippi 39202 —
Ironwood Investigational Site St Louis Missouri 63128-2197 —
Ironwood Investigational Site Bozeman Montana 59718 —
Ironwood Investigational Site Las Vegas Nevada 89119 —
Ironwood Investigational Site Las Vegas Nevada 89121 —
Ironwood Investigational Site Brooklyn New York 11206 —
Ironwood Investigational Site Charlotte North Carolina 28210 —
Ironwood Investigational Site Concord North Carolina 28025 —
Ironwood Investigational Site Davidson North Carolina 28036 —
Ironwood Investigational Site Fayetteville North Carolina 28304 —
Ironwood Investigational Site Wilmington North Carolina 28401 —
Ironwood Investigational Site Winston-Salem North Carolina 27103 —
Ironwood Investigational Site Cincinnati Ohio 45219 —
Ironwood Investigational Site Cincinnati Ohio 45224 —
Ironwood Investigational Site Mentor Ohio 44060 —
Ironwood Investigational Site Xenia Ohio 45385 —
Ironwood Investigational Site Pittsburgh Pennsylvania 15206 —
Ironwood Investigational Site Dakota Dunes South Dakota 57049 —
Ironwood Investigational Site Bristol Tennessee 37620 —
Ironwood Investigational Site Chattanooga Tennessee 37421 —
Ironwood Investigational Site Knoxville Tennessee 37909 —
Ironwood Investigational Site Arlington Texas 76012 —
Ironwood Investigational Site Beaumont Texas 77001 —
Ironwood Investigational Site El Paso Texas 79905 —
Ironwood Investigational Site Houston Texas 77074 —
Ironwood Investigational Site San Antonio Texas 78209 —
Ironwood Investigational Site San Antonio Texas 78229 —
Ironwood Investigational Site San Antonio Texas 78258 —
Ironwood Investigational Site Ogden Utah 84405 —
Ironwood Investigational Site Sandy City Utah 84094 —
Ironwood Investigational Site Christiansburg Virginia 24073 —
Ironwood Investigational Site Lynchburg Virginia 24502 —
Ironwood Investigational Site La Crosse Wisconsin 54601 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02559206, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 24, 2020 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02559206 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →