Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Completed · Phase 3 · NCT05643534
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
At a glance
- Research payments reported, 2025
- $506,440
- U.S. investigators named
- 20
- Sites paid
- 21
- Planned or actual enrollment
- 180
About the trial
- Sponsor
- Ardelyx
- Tested
- Tenapanor 50 MG (drug), Tenapanor 25 mg bid (drug), Placebo (drug)
- Dates
- Started 2022-11-15; completion 2026-08-20
- Results posted
- Not yet
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and \<18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
From ClinicalTrials.gov, last updated 2026-09-22. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ardelyx, Inc. reported $506,440 in research payments for this study in 2025 (131 payments).
Products named: Ibsrela
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
- Eve C. Shapiro, MD Pediatrics · Tucson, AZ
- Guillermo A. Fonseca, M.D. Family Medicine · Miami, FL
- Akash Pandey Pediatric Gastroenterology · Orlando, FL
- Ana Roig-cantisano, MD Adolescent Medicine · Miami, FL
- Rennan M. Quijano, M.D. Pediatrics · Madisonville, KY
- Corey Baker, M.D. Pediatric Gastroenterology · Boston, MA
- George H. Russell, MD Pediatric Gastroenterology · Portland, ME
- Glenn R. Gourley, M.D. Pediatric Gastroenterology · Minneapolis, MN
- Craig A. Friesen, M.D. Pediatric Gastroenterology · Kansas City, MO
- Angela Hira, DO Gastroenterology · Raleigh, NC
- Jon A. Vanderhoof, MD Pediatric Gastroenterology · Boys Town, NE
- Giancarlo R. Guido, M.D. Pediatrics · Bronx, NY
- Thomas Wallach, MD Pediatric Gastroenterology · New York, NY
- Tiffany Pluto, D.O. Family Medicine · Scottdale, PA
- Jonathan E. Markowitz, M.D. Pediatric Gastroenterology · Greenville, SC
- Subodh K. Bhuchar, MD Family Medicine · Sugar Land, TX
- Leonel Reyes, M.D. Family Medicine · San Antonio, TX
- Mihaela Ringheanu, MD Pediatric Gastroenterology · Harlingen, TX
- Manu R. Sood, MD Pediatric Gastroenterology · Milwaukee, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Waterway Research & Associates Corp $93,044
- Florida Pharmaceutical Research and Associates Inc $78,566
- Frontier Clinical Research LLC $70,639
- Pioneer Research Solutions Inc $52,429
- Advantage Clinical Trials $31,911
- Sun Research Institute LLC $27,867
- Connecticut Childrens Medical Center, CT $21,500
- Osf Heart of Mary Medical Center, IL $20,902
- Javara Inc $18,462
- Southern Maine Health Care $15,928
- Texas Digestive Specialists $14,750
- Orlando Health, FL $14,150
- The Research Foundation for The State University of New York $12,789
- Advanced Research Center Inc $10,188
- Boys Town $8,742
- Prisma Health PAtewood Hospital, SC $3,725
- Eclipse Clinical Research $3,500
- The Children's Mercy Hospital, MO $2,350
- M3 Wake Research Inc $2,000
- G & L Research LLC $1,500
- Osf Saint Francis Medical Center $1,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.