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Could this pill ease tummy troubles for kids with IBS-C?

NCT ID NCT06553547

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This study tests a medicine called tenapanor in children aged 6 to 12 who have irritable bowel syndrome with constipation (IBS-C). The goal is to see if it safely improves bowel movements and reduces belly discomfort. About 72 children will receive either the drug or a placebo for 4 weeks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2026

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 11 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 \<12 years old at the Screening visit (Visit 1) 2. Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential. 3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C 4. 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) 5. Meet the entry criteria assessed during the 2-week Screening period 6. 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 7. Patient must provide verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures Exclusion Criteria: 1. Functional diarrhea as defined by Modified Rome IV child/adolescent criteria 2. IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria 3. History of non-retentive fecal incontinence; 4. Required manual disimpaction any time prior to randomization (after consent) 5. Currently has both unexplained and clinically significant alarm symptoms (lower gastrointestinal \[GI\] bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process. 6. Patient has any of the following conditions: 1. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy; 2. Cystic fibrosis; 3. Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit; 4. Down's syndrome or any other chromosomal disorder; 5. Active anal fissure (Note: History of anal fissure is not an exclusion); 6. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus); 7. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies); 8. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma); 9. Lead toxicity, hypercalcemia; 10. Neurodevelopmental disabilities 11. Inflammatory bowel disease 12. Childhood functional abdominal pain syndrome 13. Childhood functional abdominal pain 14. Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; 15. Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study 16. History of cancer other than treated basal cell carcinoma of the skin; 17. History of diabetic neuropathy. 7. Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator. 8. Patient has had surgery that meets any of the following criteria: 1. Surgery to remove a segment of the GI tract at any time before the Screening Visit; 2. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit; 3. An appendectomy or cholecystectomy during the 60 days before the Screening Visit; 4. Other major surgery during the 30 days before the Screening Visit 9. History of alcohol or substance abuse 10. Participation in other clinical trials within 1 month prior to Screening 11. Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial 12. If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205, United States

  • Boys Town National Research Hospital

    Boys Town, Nebraska, 68010, United States

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida, 33143, United States

  • Mankato Clinic Children's Health Center

    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

  • Proactive El Paso, LLC

    El Paso, Texas, 79902, 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

  • University Physicians and Surgeons, Inc

    Huntington, West Virginia, 25701, United States

  • Valencia Medical and Research Center

    Miami, Florida, 33165, United States

  • Waterway Research & Associates Corp.

    Miami, Florida, 33155, United States

  • Wilmington Health

    Wilmington, North Carolina, 28401, United States

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