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RECRUITING
NCT05643534
PHASE3

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Sponsor: Ardelyx

View on ClinicalTrials.gov

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

DRUG

Tenapanor 50 MG

Participants will receive tenapanor 50 mg BID (total of 100 mg daily)

DRUG

Tenapanor 25 mg bid

Participants will receive tenapanor 25 mg BID (total of 50 mg daily)

DRUG

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