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RECRUITING
NCT06553547
PHASE2

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Sponsor: Ardelyx

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Official title: 4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

Key Details

Gender

All

Age Range

6 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-07-24

Completion Date

2026-06

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Tenapanor

Tenapanor 5 mg/mL solution

DRUG

Placebo

Matching Placebo solution

Locations (17)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Connecticut Children's Medical Center

Hartford, Connecticut, 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

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Mankato Clinic Children's Health Center

Mankato, Minnesota, United States

Boys Town National Research Hospital

Boys Town, Nebraska, United States

One Perkins Square

Akron, Ohio, United States

Prisma Health Children's Hospital

Greenville, South Carolina, 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

Pioneer Research Solutions Inc

Sugar Land, Texas, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

University Physicians and Surgeons, Inc

Huntington, West Virginia, United States