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Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Sponsor: Ardelyx
Summary
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Official title: An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-02-17
Completion Date
2031-10
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
Tenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Locations (22)
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
Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 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
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
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
Pioneer Research Solutions Inc
Sugar Land, Texas, United States
Frontier Clinical Research
Kingwood, West Virginia, United States