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Enrolling by invitation Phase 3

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

NCT05905926 · tracked via the Priya Life Science USA tracker
Sponsor
Ardelyx
Phase
Phase 3
Started
2023-02-17
Last updated
2026-06-04

Condition(s) studied

Irritable Bowel Syndrome With Constipation (IBS-C)

Investigational drug(s) / intervention(s)

Tenapanor →

Tenapanor: Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID

Study summary

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. ≥6 and \<18 years old at enrollment of either parent study 2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator 3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence). 4. Subject is ambulatory 5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described Exclusion Criteria: 1. Patient discontinued prematurely from the parent study. 2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy 3. Pregnant or lactating women 4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol

Primary outcome measure(s)

  • Safety Measure Assessment (Adverse Event) — 40 weeks
    Incidence of AEs, SAEs and drug related adverse events
  • Safety Measure Assessment (ECG) — 40 weeks
    Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)

Trial sites (27)

FacilityCityRegionStatus
G & L Research, LLC Foley Alabama
Advanced Research Center, Inc. Anaheim California
Prohealth Research Center Doral Florida
I.H.S. Health, LLC Kissimmee Florida
Valencia Medical and Research Center Miami Florida
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition Orlando Florida
Florida Pharmaceutical Research and Associates, Inc. South Miami Florida
OSF Saint Francis Medical Center Peoria Illinois
Riley Children's Health Indianapolis Indiana
Maine Health Portland Maine
Mankato Clinic/ Javara Research Ltd Mankato Minnesota
Boys Town National Research Hospital Boys Town Nebraska
SUNY Downstate Medical Center Brooklyn New York
Advantage Clinical Trials The Bronx New York
Atrium Health Charlotte North Carolina
Duke University School of Medicine Durham North Carolina
Wilmington Health Wilmington North Carolina
Frontier Clinical Research, LLC Scottdale Pennsylvania
Frontier Clinical Research, LLC Smithfield Pennsylvania
Prisma Health Children's Hospital Greenville South Carolina
Advance Clinical Trial PLLC Abilene Texas
Maspons Pediatric Gastro El Paso Texas
Texas Digestive Specialists Harlingen Texas
AIM Trials, LLC Plano Texas
Sun Research Institute San Antonio Texas
Pioneer Research Solutions Inc Sugar Land Texas
Frontier Clinical Research Kingwood West Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05905926 on ClinicalTrials.gov ↗ ← All trials in the USA