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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05643534

Public ClinicalTrials.gov record NCT05643534. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 18, 2026, 4:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT05643534
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ardelyx
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Tenapanor 25 mg bid Drug
  • Tenapanor 50 MG Drug

Drug

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 14, 2022
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update posted
Jan 11, 2026

2022 – 2026

United States locations

U.S. sites
41
U.S. states
22
U.S. cities
39
Facility City State ZIP Site status
G & L Research, LLC Foley Alabama 36535 Completed
Eclipse Clinical Research Tucson Arizona 85745 Recruiting
Advanced Research Center, Inc. Anaheim California 92805 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Prohealth Research Center Doral Florida 33166 Recruiting
I.H.S. Health, LLC Kissimmee Florida 34741 Terminated
Waterway Research & Associates Corp Miami Florida 33155 Recruiting
Valencia Medical and Research Center Miami Florida 33165 Recruiting
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition Orlando Florida 32806 Recruiting
Florida Pharmaceutical Research and Associates, Inc. South Miami Florida 33143 Recruiting
Clinical Research Institute Stockbridge Georgia 30281 Completed
OSF Saint Francis Medical Center Peoria Illinois 61637 Recruiting
Riley Children's Health IUH Indianapolis Indiana 46202 Recruiting
Maine Health Portland Maine 04102 Recruiting
Boston Children's Hospital Boston Massachusetts 02115 Recruiting
Mankato Clinic/ Javara Research Ltd Mankato Minnesota 56001 Recruiting
Children's Mercy Hospital Kansas City Missouri 64108 Withdrawn
Boys Town National Research Hospital Boys Town Nebraska 68010 Recruiting
Med Clinical Research Partners, LLC Irvington New Jersey 07111 Recruiting
University of New Mexico Health Sciences Center Albuquerque New Mexico 87131 Completed
SUNY Downstate Medical Center Brooklyn New York 11203 Recruiting
University of Rochester Rochester New York 14642 Recruiting
Advantage Clinical Trials The Bronx New York 10467 Completed
Atrium Health Charlotte North Carolina 28203 Recruiting
Duke University School of Medicine Durham North Carolina 27705 Recruiting
M3 Wake Research, Inc Raleigh North Carolina 27612 Withdrawn
Wilmington Health Wilmington North Carolina 28401 Recruiting
Frontier Clinical Research, LLC Scottdale Pennsylvania 15683 Recruiting
Frontier Clinical Research, LLC Smithfield Pennsylvania 15478 Recruiting
Velocity Clinical Research, Providence East Greenwich Rhode Island 02818 Withdrawn
Prisma Health Children's Hospital Greenville South Carolina 29615 Recruiting
Advance Clinical Trial PLLC Abilene Texas 79606 Recruiting
Maspons Pediatric Gastro El Paso Texas 79902 Recruiting
Proactive El Paso, LLC El Paso Texas 79902 Recruiting
Texas Digestive Specialists Harlingen Texas 78550 Recruiting
AIM Trials, LLC Plano Texas 75093 Completed
Sun Research Institute San Antonio Texas 78215 Recruiting
Pioneer Research Solutions Inc Sugar Land Texas 77479 Recruiting
ClinPoint Trials Waxahachie Texas 75165 Recruiting
University Physicians and Surgeons, Inc. Huntington West Virginia 25701 Recruiting
Frontier Clinical Research Kingwood West Virginia 26537 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05643534, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2026 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05643534 live on ClinicalTrials.gov.

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