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

PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 15, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
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

Trial Locations (33)

10467

RECRUITING

Advantage Clinical Trials, The Bronx

11203

RECRUITING

SUNY Downstate Medical Center, Brooklyn

15478

RECRUITING

Frontier Clinical Research, LLC, Smithfield

15683

RECRUITING

Frontier Clinical Research, LLC, Scottdale

25701

RECRUITING

University Physicians and Surgeons, Inc., Huntington

26537

RECRUITING

Frontier Clinical Research, Kingwood

27612

WITHDRAWN

M3 Wake Research, Inc, Raleigh

28203

RECRUITING

Atrium Health, Charlotte

29615

RECRUITING

Prisma Health Children's Hospital, Greenville

30281

RECRUITING

Clinical Research Institute, Stockbridge

32806

RECRUITING

Orlando Health, Inc.- APH Center for Digestive Health and Nutrition, Orlando

33143

RECRUITING

Florida Pharmaceutical Research and Associates, Inc., South Miami

33165

RECRUITING

Valencia Medical and Research Center, Miami

33166

RECRUITING

Prohealth Research Center, Doral

34741

TERMINATED

I.H.S. Health, LLC, Kissimmee

36535

RECRUITING

G & L Research, LLC, Foley

61637

RECRUITING

OSF Saint Francis Medical Center, Peoria

64108

RECRUITING

Children's Mercy Hospital, Kansas City

68010

RECRUITING

Boys Town National Research Hospital, Boys Town

75093

RECRUITING

AIM Trials, LLC, Plano

75165

RECRUITING

ClinPoint Trials, Waxahachie

77479

RECRUITING

Pioneer Research Solutions Inc, Sugar Land

78215

RECRUITING

Sun Research Institute, San Antonio

78550

RECRUITING

Texas Digestive Specialists, Harlingen

79606

RECRUITING

Advance Clinical Trial PLLC, Abilene

79902

RECRUITING

Maspons Pediatric Gastro, El Paso

RECRUITING

Proactive Clinical Research, El Paso

85745

RECRUITING

Eclipse Clinical Research, Tucson

87131

RECRUITING

University of New Mexico Health Sciences Center, Albuquerque

92805

RECRUITING

Advanced Research Center, Inc., Anaheim

02115

RECRUITING

Boston Children's Hospital, Boston

07111

RECRUITING

Med Clinical Research Partners, LLC, Irvington

02818

WITHDRAWN

Velocity Clinical Research, Providence, East Greenwich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ardelyx

INDUSTRY