An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
Public ClinicalTrials.gov record NCT02590432. 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.
Official title
An Open-label, Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.
Study identification
- NCT ID
- NCT02590432
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 828 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
- Nov 1, 2015 (Actual)
- Primary completion
- Feb 5, 2018 (Actual)
- Completion
- Feb 5, 2018 (Actual)
- Last update posted
- Aug 22, 2019
2015 – 2018
United States locations
- U.S. sites
- 79
- U.S. states
- 28
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| North Alabama Research Center, LLC | Athens | Alabama | 35611 | — |
| Alliance Clinical Research | Childersburg | Alabama | 35044 | — |
| G & L Research, LLC | Foley | Alabama | 36535 | — |
| Radiant Research, Inc. | Chandler | Arizona | 85224 | — |
| Radiant Research, Inc. | Scottsdale | Arizona | 85251 | — |
| Clinical Research Institute of Arizona, LLC | Surprise | Arizona | 85374 | — |
| Clinical Research Consortium | Tempe | Arizona | 85283 | — |
| Desert Sun Clinical Research, LLC. | Tucson | Arizona | 85710 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| Global Clinical Trials LLC | Costa Mesa | California | 92627 | — |
| Diagnamics Inc | Encinitas | California | 92024 | — |
| MD Studies, Inc. | Fountain Valley | California | 92708 | — |
| Research Center of Fresno, Inc. | Fresno | California | 93702 | — |
| VVCRD Clinical Research | Garden Grove | California | 92845 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Clinical Trials Research | Sacramento | California | 95821 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Precision Research Institute | San Diego | California | 92114 | — |
| Empire Clinical Research | Upland | California | 91786 | — |
| Lynn Institute of Denver | Denver | Colorado | 80246 | — |
| ZASA Clinical Research | Boynton Beach | Florida | 33472 | — |
| Meridien Research | Bradenton | Florida | 34201 | — |
| Clinical Research of Brandon LLC | Brandon | Florida | 33511 | — |
| Clinical Physiology Associates | Fort Myers | Florida | 33912 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| Center for Advanced Gastroenterology | Maitland | Florida | 32751 | — |
| Florida Medical Center and Research, Inc. | Miami | Florida | 33142 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | — |
| Accord Clinical Research | Port Orange | Florida | 32129 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Rockford Gastroenterology Associates | Rockford | Illinois | 611047 | — |
| Iowa Digestive Center, PC | Clive | Iowa | 50325 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | — |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | — |
| Health Science Research Center | Pratt | Kansas | 67124 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| KAMP Medical Research Inc | Natchitoches | Louisiana | 71457 | — |
| Coastal Research Associates, Inc. | South Weymouth | Massachusetts | 02190 | — |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | — |
| Aa Mrc Llc | Flint | Michigan | 48503 | — |
| Beyer Research | Kalamazoo | Michigan | 49009 | — |
| The Center for Clinical Trials, Inc. | Biloxi | Mississippi | 39531 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Digestive Health Associates | Reno | Nevada | 89511 | — |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | — |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87108 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| Manhattan Medical Research Practice PLLC | New York | New York | 10016 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758-1802 | — |
| UNC Health Care, University of North Carolina Medical Center, Memorial Hospital | Chapel Hill | North Carolina | 27514 | — |
| PharmQuest | Greensboro | North Carolina | 27408 | — |
| Northstate Clinical Research | Lenoir | North Carolina | 38645 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Clinical Inquest Center LTD | Dayton | Ohio | 45419 | — |
| Dayton Gastroenterology, Inc. | Dayton | Ohio | 45440 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Preferred Primary Care Physicians, INC | Pittsburgh | Pennsylvania | 15236 | — |
| Montgomery Medical, Inc. | Smithfield | Pennsylvania | 15478 | — |
| Partners In Clinical Research | Cumberland | Rhode Island | 02864 | — |
| Greenville Pharmaceutical Research, Inc. | Greenville | South Carolina | 29615 | — |
| Radiant Research, Inc. | Greer | South Carolina | 29651 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Houston Endoscopy & Research Center | Houston | Texas | 77079 | — |
| Research Across America | Plano | Texas | 75093 | — |
| Sun Research Institute | San Antonio | Texas | 78125 | — |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | — |
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 NCT02590432, 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 Aug 22, 2019 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02590432 live on ClinicalTrials.gov.