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Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Sponsor: Ardelyx
Summary
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.
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2022-11-15
Completion Date
2026-06-01
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
Tenapanor 50 MG
Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
Tenapanor 25 mg bid
Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
Placebo
Participants will be randomized to receive matching placebo
Locations (41)
G & L Research, LLC
Foley, Alabama, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Prohealth Research Center
Doral, Florida, United States
I.H.S. Health, LLC
Kissimmee, Florida, United States
Waterway Research & Associates Corp
Miami, 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
Clinical Research Institute
Stockbridge, Georgia, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Riley Children's Health IUH
Indianapolis, Indiana, United States
Maine Health
Portland, Maine, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mankato Clinic/ Javara Research Ltd
Mankato, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Boys Town National Research Hospital
Boys Town, Nebraska, United States
Med Clinical Research Partners, LLC
Irvington, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
University of Rochester
Rochester, 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
M3 Wake Research, Inc
Raleigh, 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
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 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
Proactive El Paso, LLC
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
ClinPoint Trials
Waxahachie, Texas, United States
University Physicians and Surgeons, Inc.
Huntington, West Virginia, United States
Frontier Clinical Research
Kingwood, West Virginia, United States