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New drug tested for kids with chronic constipation

NCT ID NCT05905926

Symptom relief Sponsor: Ardelyx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing the long-term safety of tenapanor (Ibsrela) in children aged 6 to 17 with irritable bowel syndrome with constipation (IBS-C). About 150 kids who completed a prior study will continue taking the drug for up to one year. Researchers will monitor side effects and heart health to see if the drug is safe for long-term use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tenapanor (Ibsrela)
What this could lead to
If successful, this could confirm tenapanor as a safe long-term option for managing IBS-C symptoms in children.
What could go wrong
This is an open-label safety study, not a placebo-controlled efficacy trial, so results may not prove how well it works. Side effects are possible, and long-term use in children is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome with constipation (IBS-C)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIM Trials, LLC

    Plano, Texas, 75093, United States

  • Advance Clinical Trial PLLC

    Abilene, Texas, 79606, United States

  • Advanced Research Center, Inc.

    Anaheim, California, 92805, United States

  • Advantage Clinical Trials

    The Bronx, New York, 10467, United States

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Boys Town National Research Hospital

    Boys Town, Nebraska, 68010, United States

  • Duke University School of Medicine

    Durham, North Carolina, 27705, United States

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida, 33143, United States

  • Frontier Clinical Research

    Kingwood, West Virginia, 26537, United States

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683, United States

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478, United States

  • G & L Research, LLC

    Foley, Alabama, 36535, United States

  • I.H.S. Health, LLC

    Kissimmee, Florida, 34741, United States

  • Maine Health

    Portland, Maine, 04102, United States

  • Mankato Clinic/ Javara Research Ltd

    Mankato, Minnesota, 56001, United States

  • Maspons Pediatric Gastro

    El Paso, Texas, 79902, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

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

    Orlando, Florida, 32806, United States

  • Pioneer Research Solutions Inc

    Sugar Land, Texas, 77479, United States

  • Prisma Health Children's Hospital

    Greenville, South Carolina, 29615, United States

  • Prohealth Research Center

    Doral, Florida, 33166, United States

  • Riley Children's Health

    Indianapolis, Indiana, 46202, United States

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Texas Digestive Specialists

    Harlingen, Texas, 78550, United States

  • Valencia Medical and Research Center

    Miami, Florida, 33165, United States

  • Wilmington Health

    Wilmington, North Carolina, 28401, United States

More trials for these conditions

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