What this study is
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
What's being tested
- Tenapanor
Intervention · DRUG
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 details
- Official title
- An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
- Sponsor
- Ardelyx
- Conditions
- Irritable Bowel Syndrome With Constipation (IBS-C)
- Enrolling
- 150 people
- Starts
- 2023-02-17
- Est. completion
- 2031-10
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥6 and <18 years old at enrollment of either parent study
- Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
- 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).
- Subject is ambulatory
- 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
You can't join if
- Patient discontinued prematurely from the parent study.
- Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
- Pregnant or lactating women
- If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (27)
27 openG & L Research, LLC
Foley, Alabama, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Prohealth Research Center
Doral, Florida, United States
I.H.S. Health, LLC
Kissimmee, 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
Riley Children's Health
Indianapolis, Indiana, United States
Maine Health
Portland, Maine, United States
Mankato Clinic/ Javara Research Ltd
Mankato, Minnesota, United States
Boys Town National Research Hospital
Boys Town, Nebraska, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Advantage Clinical Trials
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University School of Medicine
Durham, North Carolina, United States
Wilmington Health
Wilmington, North Carolina, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Prisma Health Children's Hospital
Greenville, South Carolina, United States
Advance Clinical Trial PLLC
Abilene, Texas, United States
Maspons Pediatric Gastro
El Paso, Texas, United States
Texas Digestive Specialists
Harlingen, Texas, United States
AIM Trials, LLC
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Pioneer Research Solutions Inc
Sugar Land, Texas, United States
Frontier Clinical Research
Kingwood, West Virginia, United States
Study team
Sponsor
Ardelyx
Study ID TEN-01-306
Study director
Jocelyn Tabora
Ardelyx
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.