Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Public ClinicalTrials.gov record NCT04166058. 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
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.
Study identification
- NCT ID
- NCT04166058
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 381 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Years to 18 Years
- 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 19, 2019 (Actual)
- Primary completion
- Jun 5, 2025 (Actual)
- Completion
- Jun 5, 2025 (Actual)
- Last update posted
- Jan 6, 2026
2019 – 2025
United States locations
- U.S. sites
- 65
- U.S. states
- 26
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates /ID# 237953 | Birmingham | Alabama | 35205 | — |
| G & L Research, LLC /ID# 238093 | Foley | Alabama | 36535 | — |
| The Center for Clinical Trials Inc. /ID# 234605 | Saraland | Alabama | 36571 | — |
| HealthStar Research of Hot Springs PLLC /ID# 234608 | Hot Springs | Arkansas | 71913 | — |
| Preferred Research Partners /ID# 237109 | Little Rock | Arkansas | 72211 | — |
| Applied Research Center of Arkansas /ID# 238069 | Little Rock | Arkansas | 72212-4187 | — |
| Advanced Research Center /ID# 237960 | Anaheim | California | 92805 | — |
| Kindred Medical Institute, LLC /ID# 237367 | Corona | California | 92879 | — |
| Duplicate_Center for Clinical Trials LLC /ID# 234629 | Paramount | California | 90723 | — |
| Medical Ctr for Clin Research /ID# 236911 | San Diego | California | 92108 | — |
| Lynn Institute of Denver /ID# 238086 | Aurora | Colorado | 80012 | — |
| Childrens National Medical Center /ID# 234417 | Washington D.C. | District of Columbia | 20010-2916 | — |
| Prohealth Research Center /ID# 234659 | Doral | Florida | 33166 | — |
| Dolphin Medical Research /ID# 234676 | Doral | Florida | 33172 | — |
| Amedica Research Institute Inc /ID# 234666 | Hialeah | Florida | 33013 | — |
| Nemours Childrens Specialty Care /ID# 237991 | Jacksonville | Florida | 32207 | — |
| Elite Clinical Research /ID# 234651 | Miami | Florida | 33144 | — |
| My Preferred Research LLC /ID# 237943 | Miami | Florida | 33155 | — |
| South Miami Medical & Research Group Inc. /ID# 234654 | Miami | Florida | 33155 | — |
| Valencia Medical & Research Center /ID# 234671 | Miami | Florida | 33165 | — |
| Advanced Research for Health Improvement /ID# 238253 | Naples | Florida | 34102-5430 | — |
| Pediatric & Adult Research Center /ID# 234681 | Orlando | Florida | 32825 | — |
| Nemours Children's Hospital /ID# 234429 | Orlando | Florida | 32827-7884 | — |
| Oviedo Medical Research /ID# 234692 | Oviedo | Florida | 32765 | — |
| Treken Primary Care /ID# 234645 | Atlanta | Georgia | 30315 | — |
| Children's Healthcare of Atlanta - Ferry Rd /ID# 237005 | Atlanta | Georgia | 30342-1605 | — |
| Children's Ctr Digestive, US /ID# 237574 | Atlanta | Georgia | 30342 | — |
| River Birch Research Alliance /ID# 237963 | Blue Ridge | Georgia | 30513 | — |
| Clinical Research Institute /ID# 234702 | Stockbridge | Georgia | 30281 | — |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342 | Stockbridge | Georgia | 30281 | — |
| KU Wichita Center for Clinical Research /ID# 234500 | Wichita | Kansas | 67214 | — |
| Michael W. Simon, MD, PSC /ID# 236516 | Lexington | Kentucky | 40517 | — |
| Virgo Carter Pediatrics /ID# 234518 | Silver Spring | Maryland | 20910 | — |
| MNGI Digestive Health, P. A. /ID# 234437 | Minneapolis | Minnesota | 55413-2195 | — |
| GI associates and Endoscopy Ce /ID# 237969 | Flowood | Mississippi | 39232 | — |
| David M. Headley, MD, P.A. /ID# 238216 | Port Gibson | Mississippi | 39150-2024 | — |
| Private Practice - Dr. Craig Spiegel /ID# 234545 | Bridgeton | Missouri | 63044 | — |
| Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566 | East Orange | New Jersey | 07018 | — |
| University of New Mexico /ID# 236983 | Albuquerque | New Mexico | 87102-4517 | — |
| Columbia University Irving Medical Center /ID# 235686 | New York | New York | 10032 | — |
| Advantage Clinical Trials /ID# 237932 | The Bronx | New York | 10468 | — |
| East Carolina University - Brody School of Medicine /ID# 237509 | Greenville | North Carolina | 27834 | — |
| PMG Research of Piedmont Healthcare-Statesville /ID# 238257 | Statesville | North Carolina | 28625 | — |
| Univ Oklahoma HSC /ID# 237546 | Oklahoma City | Oklahoma | 73104 | — |
| IPS Research Company /ID# 237669 | Oklahoma City | Oklahoma | 73106 | — |
| Frontier Clinical Research, LLC - Scottdale /ID# 238022 | Scottdale | Pennsylvania | 15683 | — |
| Duplicate_Frontier Clinical Research /ID# 237923 | Smithfield | Pennsylvania | 15478 | — |
| Rhode Island Hospital /ID# 237861 | Providence | Rhode Island | 02903 | — |
| Coastal Pediatric Research - West Ashley B /ID# 234678 | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Research - Summerville /ID# 234674 | Summerville | South Carolina | 29486 | — |
| The Jackson Clinic, PA /ID# 236772 | Jackson | Tennessee | 38305 | — |
| Accellacare of Knoxville /ID# 234462 | Jefferson City | Tennessee | 37760 | — |
| Cook Children's Med. Center /ID# 237536 | Fort Worth | Texas | 76104 | — |
| Valley Institute of Research /ID# 234475 | Harlingen | Texas | 78550 | — |
| Vilo Research Group Inc /ID# 238228 | Houston | Texas | 77017-2337 | — |
| Cullen Research /ID# 234482 | Houston | Texas | 77051 | — |
| Pioneer Research Solutions - Houston /ID# 236935 | Houston | Texas | 77099-4307 | — |
| AIM Trials /ID# 236364 | Plano | Texas | 75093 | — |
| Sun Research Institute /ID# 236932 | San Antonio | Texas | 78215 | — |
| ClinPoint Trials /ID# 236615 | Waxahachie | Texas | 75165-1430 | — |
| Duplicate_Chrysalis Clinical Research /ID# 234515 | St. George | Utah | 84790 | — |
| Office of Maria Ona /ID# 234539 | Franklin | Virginia | 23851 | — |
| Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252 | Newport News | Virginia | 23606 | — |
| Clinical Research Partners, LLC /ID# 237158 | Richmond | Virginia | 23220-4459 | — |
| Duplicate_Multicare Institute for Research and Innovation /ID# 236979 | Tacoma | Washington | 98405 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04166058, 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 Jan 6, 2026 · Synced Oct 20, 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 NCT04166058 live on ClinicalTrials.gov.