Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Completed · Phase 3 · NCT04166058
Conditions: Irritable Bowel Syndrome With Constipation, Functional Constipation
At a glance
- Research payments reported, 2025
- $82,885
- U.S. investigators named
- 10
- Sites paid
- 9
- Planned or actual enrollment
- 381
About the trial
- Sponsor
- AbbVie (with Ironwood Pharmaceuticals, Inc.)
- Tested
- Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) (drug), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) (drug)
- Dates
- Started 2019-11-19; completion 2025-06-05
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-01-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $82,885 in research payments for this study in 2025 (26 payments).
Products named: Linzess
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- John T. Baber SR., MD Gastroenterology · Little Rock, AR
- Louis D. Velez, M.D. Gastroenterology · Little Rock, AR
- Austina B. Cho, M.D. Psychiatry · Orange, CA
- Mohammad A. Mahmud, MD, MPH, PHD Internal Medicine · Corona, CA
- Inti Fernandez, M.D General Practice · Miami, FL
- Edgar Gonzalez, M.D General Practice · Miami, FL
- Katherine E. Mcgoogan, MD Pediatric Gastroenterology · Jacksonville, FL
- Julie Khlevner, MD Pediatric Gastroenterology · New York, NY
- Roberto A. Gomez-suarez, M.D. Pediatric Gastroenterology · San Antonio, TX
- Samuel N. Landero, MD Family Medicine · Harlingen, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Nemours Childrens Hospital, Florida, FL $46,830
- The Trustees of Columbia University $13,062
- Valencia Medical & Research $9,722
- Applied Research Center of Arkansas $4,100
- Valley Institute of Research $2,869
- Preferred Research PArtners Inc $2,791
- Kindred Medical Institute for Clinical Trials LLC $1,975
- Advanced Research Center Inc $1,350
- South Miami Medical & Research Group Inc $187
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.