Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
Public ClinicalTrials.gov record NCT04026113. 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, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) and of Linaclotide Versus Placebo in Pediatric Participants With Functional Constipation (FC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.
Study identification
- NCT ID
- NCT04026113
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 438 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Years to 17 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
- Oct 1, 2019 (Actual)
- Primary completion
- May 20, 2024 (Actual)
- Completion
- May 29, 2024 (Actual)
- Last update posted
- Nov 26, 2024
2019 – 2024
United States locations
- U.S. sites
- 79
- U.S. states
- 28
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates /ID# 233124 | Birmingham | Alabama | 35205 | — |
| G & L Research, LLC /ID# 233139 | Foley | Alabama | 36535 | — |
| The Center for Clinical Trials Inc. /ID# 232755 | Saraland | Alabama | 36571 | — |
| HealthStar Research of Hot Springs PLLC /ID# 232757 | Hot Springs | Arkansas | 71913 | — |
| Preferred Research Partners /ID# 233023 | Little Rock | Arkansas | 72211 | — |
| Applied Research Center of Arkansas /ID# 233135 | Little Rock | Arkansas | 72212-4187 | — |
| Advanced Research Center /ID# 233121 | Anaheim | California | 92805 | — |
| Alliance Research Institute /ID# 232754 | Bell Gardens | California | 90201 | — |
| Alliance Research Institute Llc /Id# 232637 | Canoga Park | California | 91304 | — |
| Kindred Medical Institute, LLC /ID# 233042 | Corona | California | 92879 | — |
| Center for Clinical Trials LLC /ID# 232781 | Paramount | California | 90723 | — |
| Medical Ctr for Clin Research /ID# 233004 | San Diego | California | 92108 | — |
| Paragon Rx Clinical Inc /ID# 232752 | Santa Ana | California | 92703 | — |
| Lynn Institute of Denver /ID# 233137 | Aurora | Colorado | 80012 | — |
| Children's National Medical Center /ID# 232655 | Washington D.C. | District of Columbia | 20010-2916 | — |
| Prohealth Research Center /ID# 232805 | Doral | Florida | 33166 | — |
| Dolphin Medical Research /ID# 232815 | Doral | Florida | 33172 | — |
| Amedica Research Institute Inc /ID# 232809 | Hialeah | Florida | 33013 | — |
| Nemours Children's Health System /ID# 233127 | Jacksonville | Florida | 32207 | — |
| Elite Clinical Research /ID# 232801 | Miami | Florida | 33144 | — |
| My Preferred Research LLC /ID# 233119 | Miami | Florida | 33155 | — |
| South Miami Medical & Research Group Inc. /ID# 232803 | Miami | Florida | 33155 | — |
| Valencia Medical & Research Center /ID# 232813 | Miami | Florida | 33165 | — |
| Advanced Research for Health Improvement /ID# 233161 | Naples | Florida | 34102-5430 | — |
| Pediatric & Adult Research Center /ID# 232819 | Orlando | Florida | 32825 | — |
| Nemours Children's Hospital /ID# 232919 | Orlando | Florida | 32827-7884 | — |
| Oviedo Medical Research /ID# 232830 | Oviedo | Florida | 32765 | — |
| Treken Primary Care /ID# 232796 | Atlanta | Georgia | 30315 | — |
| Children's Healthcare of Atlanta - Ferry Rd /ID# 233015 | Atlanta | Georgia | 30342-1605 | — |
| Children's Ctr Digestive, US /ID# 233070 | Atlanta | Georgia | 30342 | — |
| River Birch Research Alliance /ID# 233122 | Blue Ridge | Georgia | 30513 | — |
| Clinical Research Institute /ID# 232833 | Stockbridge | Georgia | 30281 | — |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940 | Stockbridge | Georgia | 30281 | — |
| Clinical Trials Specialist Inc /ID# 232802 | Stone Mountain | Georgia | 30083 | — |
| Rophe Adult and Pediatric Medicine/SKYCRNG /ID# 232800 | Union City | Georgia | 30291 | — |
| Univ Kansas Med Ctr /ID# 232645 | Kansas City | Kansas | 66160 | — |
| Alliance for Multispecialty Research LLC /ID# 232681 | Newton | Kansas | 67114 | — |
| Michael W. Simon, MD, PSC /ID# 232966 | Lexington | Kentucky | 40517 | — |
| Meridian Research - Baton Rouge /ID# 232954 | Baton Rouge | Louisiana | 70806-7631 | — |
| Virgo Carter Pediatrics /ID# 232693 | Silver Spring | Maryland | 20910 | — |
| MNGI Digestive Health, P. A. /ID# 232920 | Minneapolis | Minnesota | 55413-2195 | — |
| GI associates and Endoscopy Ce /ID# 233123 | Flowood | Mississippi | 39232 | — |
| David M. Headley, MD, P.A. /ID# 233153 | Port Gibson | Mississippi | 39150-2024 | — |
| Private Practice - Dr. Craig Spiegel /ID# 232707 | Bridgeton | Missouri | 63044 | — |
| Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 232783 | East Orange | New Jersey | 07018 | — |
| University of New Mexico /ID# 233011 | Albuquerque | New Mexico | 87102-4517 | — |
| Columbia Univ Medical Center /ID# 233094 | New York | New York | 10032-3725 | — |
| The Children's Hospital at Montefiore /ID# 232638 | The Bronx | New York | 10467 | — |
| Advantage Clinical Trials /ID# 233117 | The Bronx | New York | 10468 | — |
| East Carolina University - Brody School of Medicine /ID# 233062 | Greenville | North Carolina | 27834 | — |
| PMG Research of Piedmont Healthcare-Statesville /ID# 233162 | Statesville | North Carolina | 28625 | — |
| Univ Oklahoma HSC /ID# 233067 | Oklahoma City | Oklahoma | 73104 | — |
| IPS Research Company /ID# 233081 | Oklahoma City | Oklahoma | 73106 | — |
| Frontier Clinical Research, LLC - Scottdale /ID# 233129 | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research /ID# 233116 | Smithfield | Pennsylvania | 15478 | — |
| Rhode Island Hospital /ID# 233112 | Providence | Rhode Island | 02903 | — |
| Coastal Pediatric Research - West Ashley B /ID# 232816 | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Research - Summerville /ID# 232814 | Summerville | South Carolina | 29486 | — |
| The Jackson Clinic, PA /ID# 232998 | Jackson | Tennessee | 38305 | — |
| Accellacare of Knoxville /ID# 232663 | Jefferson City | Tennessee | 37760 | — |
| Monroe-Carell Jr. Children's Hospital at Vanderbilt /ID# 232659 | Nashville | Tennessee | 37232 | — |
| Oak Cliff Research Company LLC /ID# 232729 | Dallas | Texas | 75243 | — |
| Cook Children's Med. Center /ID# 233066 | Fort Worth | Texas | 76104 | — |
| Valley Institute of Research /ID# 232674 | Harlingen | Texas | 78550 | — |
| Vilo Research Group Inc /ID# 233155 | Houston | Texas | 77017-2337 | — |
| Cullen Research /ID# 232726 | Houston | Texas | 77051 | — |
| Synergy Group US LLC /ID# 232669 | Houston | Texas | 77061 | — |
| Pioneer Research Solutions - Houston /ID# 233006 | Houston | Texas | 77099-4307 | — |
| Synergy Group US LLC /ID# 232670 | Missouri City | Texas | 77459 | — |
| AIM Trials /ID# 232934 | Plano | Texas | 75093 | — |
| Sun Research Institute /ID# 233005 | San Antonio | Texas | 78215 | — |
| ClinPoint Trials /ID# 232978 | Waxahachie | Texas | 75165-1430 | — |
| Chrysalis Clinical Research /ID# 232690 | St. George | Utah | 84790 | — |
| Office of Maria Ona /ID# 232700 | Franklin | Virginia | 23851 | — |
| Health Research of Hampton Roads, Inc. (HRHR) /ID# 233056 | Newport News | Virginia | 23606 | — |
| Clinical Research Partners, LLC /ID# 233026 | Richmond | Virginia | 23220-4459 | — |
| Carilion Medical Center /ID# 232999 | Roanoke | Virginia | 24014 | — |
| Duplicate_Multicare Institute for Research and Innovation /ID# 233010 | Tacoma | Washington | 98405 | — |
| Marshall University Medical Center /ID# 232952 | Huntington | West Virginia | 25701-3656 | — |
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 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04026113, 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 Nov 26, 2024 · Synced Oct 24, 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 NCT04026113 live on ClinicalTrials.gov.