Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Enrolling by invitation · Phase 3

Conditions studied: Irritable Bowel Syndrome With Constipation (IBS-C)

In brief

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Key facts

Study ID

NCT05905926

Run by

Ardelyx

People needed

150

Starts

2023-02-17

Expected to finish

2031-10-01

Last updated by the study team

2026-06-04

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥6 and <18 years old at enrollment of either parent study
• Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
• Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
• Subject is ambulatory
• Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described

You may not qualify if…

• Patient discontinued prematurely from the parent study.
• Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
• Pregnant or lactating women
• If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Where it is running

• G & L Research, LLC — Foley, Alabama, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• Prohealth Research Center — Doral, Florida, United States
• I.H.S. Health, LLC — Kissimmee, Florida, United States
• Valencia Medical and Research Center — Miami, Florida, United States
• Orlando Health, Inc.- APH Center for Digestive Health and Nutrition — Orlando, Florida, United States
• Florida Pharmaceutical Research and Associates, Inc. — South Miami, Florida, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Riley Children's Health — Indianapolis, Indiana, United States
• Maine Health — Portland, Maine, United States
• Mankato Clinic/ Javara Research Ltd — Mankato, Minnesota, United States
• Boys Town National Research Hospital — Boys Town, Nebraska, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Advantage Clinical Trials — The Bronx, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Wilmington Health — Wilmington, North Carolina, United States
• Frontier Clinical Research, LLC — Scottdale, Pennsylvania, United States
• Frontier Clinical Research, LLC — Smithfield, Pennsylvania, United States
• Prisma Health Children's Hospital — Greenville, South Carolina, United States
• Advance Clinical Trial PLLC — Abilene, Texas, United States
• Maspons Pediatric Gastro — El Paso, Texas, United States
• Texas Digestive Specialists — Harlingen, Texas, United States
• AIM Trials, LLC — Plano, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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