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
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• ≥12 and \<18 years old
• Patient weighs ≥18 kg at the time the patient provides written assent
• Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
• Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
• Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
• Patient meets the entry criteria assessed during the 2-week Screening period.
• Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
• Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
Locations
United States
Alabama
G & L Research, LLC
RECRUITING
Foley
Arizona
Eclipse Clinical Research
RECRUITING
Tucson
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
Florida
Prohealth Research Center
RECRUITING
Doral
I.H.S. Health, LLC
TERMINATED
Kissimmee
Valencia Medical and Research Center
RECRUITING
Miami
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
RECRUITING
Orlando
Florida Pharmaceutical Research and Associates, Inc.
RECRUITING
South Miami
Georgia
Clinical Research Institute
RECRUITING
Stockbridge
Illinois
OSF Saint Francis Medical Center
RECRUITING
Peoria
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
North Carolina
Atrium Health
RECRUITING
Charlotte
M3 Wake Research, Inc
WITHDRAWN
Raleigh
Nebraska
Boys Town National Research Hospital
RECRUITING
Boys Town
New Jersey
Med Clinical Research Partners, LLC
RECRUITING
Irvington
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
SUNY Downstate Medical Center
RECRUITING
Brooklyn
Advantage Clinical Trials
RECRUITING
The Bronx
Pennsylvania
Frontier Clinical Research, LLC
RECRUITING
Scottdale
Frontier Clinical Research, LLC
RECRUITING
Smithfield
Rhode Island
Velocity Clinical Research, Providence
WITHDRAWN
East Greenwich
South Carolina
Prisma Health Children's Hospital
RECRUITING
Greenville
Texas
Advance Clinical Trial PLLC
RECRUITING
Abilene
Maspons Pediatric Gastro
RECRUITING
El Paso
Proactive Clinical Research
RECRUITING
El Paso
Texas Digestive Specialists
RECRUITING
Harlingen
AIM Trials, LLC
RECRUITING
Plano
Sun Research Institute
RECRUITING
San Antonio
Pioneer Research Solutions Inc
RECRUITING
Sugar Land
ClinPoint Trials
RECRUITING
Waxahachie
West Virginia
University Physicians and Surgeons, Inc.
RECRUITING
Huntington
Frontier Clinical Research
RECRUITING
Kingwood
Contact Information
Primary
Jocelyn Tabora
jtabora@ardelyx.com
510-745-1724
Backup
Susan Edelstein, PhD
sedelstein@ardelyx.com
510-456-7741
Time Frame
Start Date:2022-11-15
Estimated Completion Date:2025-12-31
Participants
Target number of participants:180
Treatments
Experimental: Tenpanor 50 mg BID
Patients will be randomized to receive 50 mg tenapanor twice daily
Experimental: Tenpanor 25 mg BID
Patients will be randomized to receive 25 mg tenapanor twice daily
Placebo_comparator: Placebo Comparator
Patients will be randomized to receive matching placebo twice daily