A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Public ClinicalTrials.gov record NCT01880424. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
Study identification
- NCT ID
- NCT01880424
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,722 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
- Jul 2013 (Type not available)
- Primary completion
- May 2015 (Actual)
- Completion
- May 2015 (Actual)
- Last update posted
- Sep 27, 2016
2013 – 2015
United States locations
- U.S. sites
- 52
- U.S. states
- 21
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Huntsville | Alabama | — | — |
| Research Site | North Little Rock | Arkansas | — | — |
| Research Site | Phoenix | Arkansas | — | — |
| Research Site | Artesia | California | — | — |
| Research Site | Chula Vista | California | — | — |
| Research Site | Encino | California | — | — |
| Research Site | North Hollywood | California | — | — |
| Research Site | Orange | California | — | — |
| Research Site | Riverside | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | Boynton Beach | Florida | — | — |
| Research Site | Brandon | Florida | — | — |
| Research Site | Brooksville | Florida | — | — |
| Research Site | Doral | Florida | — | — |
| Research Site | Gainesville | Florida | — | — |
| Research Site | Hialeah | Florida | — | — |
| Research Site | Kissimmee | Florida | — | — |
| Research Site | Lauderdale Lakes | Florida | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Miami Lakes | Florida | — | — |
| Research Site | Addison | Illinois | — | — |
| Research Site | Evansville | Indiana | — | — |
| Research Site | Crowley | Louisiana | — | — |
| Research Site | Monroe | Louisiana | — | — |
| Research Site | Shreveport | Louisiana | — | — |
| Research Site | Boston | Massachusetts | — | — |
| Research Site | Chesterfield | Michigan | — | — |
| Research Site | Wyoming | Michigan | — | — |
| Research Site | St Louis | Missouri | — | — |
| Research Site | Billings | Montana | — | — |
| Research Site | Las Vegas | Nevada | — | — |
| Research Site | Brooklyn | New York | — | — |
| Research Site | Great Neck | New York | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Salisbury | North Carolina | — | — |
| Research Site | Winston-Salem | North Carolina | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Dayton | Ohio | — | — |
| Research Site | Franklin | Ohio | — | — |
| Research Site | Mentor | Ohio | — | — |
| Research Site | Greer | South Carolina | — | — |
| Research Site | Chattanooga | Tennessee | — | — |
| Research Site | Kingsport | Tennessee | — | — |
| Research Site | Knoxville | Tennessee | — | — |
| Research Site | Smyrna | Tennessee | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | San Antonio | Texas | — | — |
| Research Site | Webster | Texas | — | — |
| Research Site | Ogden | Utah | — | — |
| Research Site | Lynchburg | Virginia | — | — |
| Research Site | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01880424, 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 Sep 27, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01880424 live on ClinicalTrials.gov.