A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Completed · Phase 3 · NCT05652205
Conditions: Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
At a glance
- Research payments reported, 2025
- $419,959
- U.S. investigators named
- 36
- Sites paid
- 45
- Planned or actual enrollment
- 123
About the trial
- Sponsor
- AbbVie (with Ironwood Pharmaceuticals, Inc.)
- Tested
- Placebo for Linaclotide (drug), Linaclotide (drug)
- Dates
- Started 2022-12-29; completion 2025-09-02
- Results posted
- Yes
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 cha…
From ClinicalTrials.gov, last updated 2026-05-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $419,959 in research payments for this study in 2025 (184 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
- Nidal Morrar, M.D. Family Medicine · Foley, AL
- Jon M. Robert, MD Pediatrics · Hot Springs, AR
- Louis D. Velez, M.D. Gastroenterology · Little Rock, AR
- Carlos J. Lopez, M.D. Family Medicine · Phoenix, AZ
- Mohammad A. Mahmud, MD, MPH, PHD Internal Medicine · Corona, CA
- Robert J. Semo, MD OB-GYN (Obstetrics & Gynecology) · San Diego, CA
- Belkis Delgado, M.D. Internal Medicine · Miami Springs, FL
- Aymin Delgado, M.D. Pediatric Gastroenterology · Naples, FL
- Inti Fernandez, M.D General Practice · Miami, FL
- Yuneisy M. Garcia, MD Pediatrics · Miami, FL
- David Jativa, MD Internal Medicine · North Miami, FL
- Maanasa Reddy Konda, M.D Hospitalist · Winter Haven, FL
- Yelena Korotkaya, MD Pediatrics · Jacksonville, FL
- Akash Pandey Pediatric Gastroenterology · Orlando, FL
- Dwight D. Blake, MD Internal Medicine · Union City, GA
- Lance E. Slade, M.D. Pediatrics · Macon, GA
- Rennan M. Quijano, M.D. Pediatrics · Madisonville, KY
- Michael W. Simon, M.D. Pediatrics · Nicholasville, KY
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Gabrielle N. Virgo, MD FAAP Pediatrics · Silver Spring, MD
- Martin P. Levinson, M.D. Pediatrics · Bingham Farms, MI
- Ramalingam Arumugam, MD Pediatric Gastroenterology · Saint Paul, MN
- Daniel J. Leonard IV, D.O. Pediatrics · Hastings, NE
- Iona Monteiro, MD Pediatric Gastroenterology · Newark, NJ
- Thomas J. Sferra, MD Pediatric Gastroenterology · Cleveland, OH
- Marcy J. Goisse, MD Family Medicine · Smithfield, PA
- Tiffany Pluto, D.O. Family Medicine · Scottdale, PA
- Robert A. Clifford, M.D. Pediatrics · Charleston, SC
- Carole I. Mercer, M.D. Adolescent Medicine · Simpsonville, SC
- Stephen W. Stripling, M.D. Pediatrics · Charleston, SC
- Peggy F. Linguist, M.D. Pediatrics · Waxahachie, TX
- Tolulope M. Olabintan, MD Family Medicine · Mansfield, TX
- Naila F. Siddiqi, MD Pediatrics · Houston, TX
- Monica P. Garin-laflam, MD Pediatric Gastroenterology · Roanoke, VA
- Matthew D. Egberg, M.D. Student in an Organized Health Care Education/Training Program · Madison, WI
- Jeffry J. Pilney, M.D. Specialist · Buckeye, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Advanced Research Center Inc $64,190
- Uh Cleveland Medical Center, OH $62,108
- Velocity Clinical Research Inc $39,725
- Frontier Clinical Research LLC $36,544
- Kindred Medical Institute for Clini $23,080
- Carilion Medical Center, VA $22,998
- Nemours Childrens Hospital, Florida, FL $19,956
- $18,077
- Clinpoint Trials LLC $14,322
- Kissimmee Clinical Research $14,117
- Michigan Center of Medical Research $12,170
- Valencia Medical & Research $11,657
- South Miami Medical & Research $9,281
- Houston Clinical Research $8,666
- Mngi Digestive Health PA $7,638
- Prime Clinical Research Inc $6,000
- Tribe Clinical Research LLC $5,339
- Wr-Mccr LLC $4,150
- University of North Carolina $4,070
- Kidz Medical Services Inc $3,699
- Rutgers the State University $3,414
- Michael W Simon MD Psc $3,371
- Orlando Health, FL $2,750
- G & L Research LLC $2,150
- Houston Clinical Research Associates $1,854
- Coastal Pediatric Associates PA $1,854
- Applied Research Center of Akansas $1,200
- South Florida Research Phase I-Iv $1,134
- Kidz Medical Services $927
- Simon Michael W Medical Group $927
- Advanced Research Center $927
- Clinpoint Trials $927
- Rophe Adult and Pediatric Medicineskycrng $927
- Kindred Medical Institute for Clinical Trials LLC $927
- Healthstar Research $850
- Applied Research Center of Arkansas $850
- Valencia Medical and Research Center $850
- South Miami Medical & Research Group Inc $773
- Elias Research Associate LLC $773
- Prohealth Research Center $773
- South Florida Research Phase IIv Inc $773
- University of North Carolina at Chapel Hill $773
- G and L Research LLC $773
- Plymouth Endoscopy Center and Clinic $773
- Certified Research Consultants $541
- Wrmccr LLC $386
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.